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Clinical Studies in the Department of Obstetrics, Gynecology, and Reproductive Sciences

Clinical Studies

Trailblazing research to discover better clinical outcomes in Obstetrics, Gynecology, and Reproductive Sciences

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Clinical Trials

Division of Complex Family Planning

UCSD Complex Family Planning Clinical Studies

Study Title Description Eligibility Contact Location
UCSD Fourth Trimester Center Project This project is dedicated to providing comprehensive postpartum care for birthing people and their newborns through integration and co-location of health services.

Sarah Averbach, MD
Sarah Averbach, MD, MAS

Postpartum Integration of Vaccines and Contraception Trial (PIVoT) The objective of this study is to assess the effect of utilizing gender-transformative strategies - i.e., those targeting restrictive gender-based norms – to deliver family planning (FP) in the context of a public health infant vaccination program in rural India. Our central hypothesis is that integrating community-based FP care with the existing infant vaccination program will reach more rural postpartum women and improve uptake of postpartum contraception.

(Inclusion): Postpartum people aged 18 and older, reside in rural Maharashtra, speak Marathi, delivered a baby within the past 8 weeks but did not undergo sterilization, hysterectomy or immediate postpartum IUD placement and do not have a new pregnancy.

(Exclusion): Under 18 years old, delivered a baby more than 8 weeks prior or planning to move out of the study area within the next 6 months. 

Sarah Averbach, MD
Sarah Averbach, MD, MAS
Postpartum progestin-only pill use and breastfeeding pilot study This study will assesses the impact of early initiation (less than one week postpartum) and delayed initiation (4 weeks postpartum) of two types of progestin-only contraceptive pills on maternal, breastmilk, and infant outcomes. This is a placebo-controlled randomized controlled trial enrolling dyads of birthing people and their newborn babies. We will explore if the type and timing of initiation of pills is acceptable to the user with minimal side effects, impacts the supply or composition of breastmilk, and/or affects infant growth.

(Inclusion): 18 years and older, speak English or Spanish, had a vaginal or cesarean delivery of a singleton full-term (>37weeks) infant less than 168 hours prior.

(Exclusion:) Patients who desire another pregnancy in less than 6 months, do not intend to exclusively breastfeed, do not have access to a smartphone, email or telephone, or have any medical contraindication to progestin-only pills (POPs) per the U.S. CDC MEC or any contraindication to breastfeeding. In addition, people with known current illegal maternal drug use, a history of breast reduction or augmentation, or an infant with a major congenital anomaly due to unique challenges with breastfeeding.

Sarah Averbach, MD
Sarah Averbach, MD, MAS
Early versus Interval Postpartum IUD Insertion: A Multi-site Randomized Controlled Trial Intrauterine devices (IUDs) are historically placed at the six-week postpartum (PP) visit for women who desire intrauterine contraception. Some women are already pregnant at that time. The early postpartum period (EPP), 2-4 weeks after delivery, could be a convenient time for women to receive contraception, including IUDs. Offering women EPP IUDs may decrease the risk of undesired pregnancy and rapid repeat pregnancy.

(Inclusion): Patients who gave birth less than or equal to 10 days ago, desires an IUD for contraception (either copper or levonorgestrel contraining), willinf and able to sign an informed consent, willing to comply with the study protocol, age great than or equal to 18 years, English or Spanish speaking.

(Exclusion): Uterine anomaly or leiomyomata which would not allow placement of an IUD, desire for repeat pregnancy in less than 6 months, evidence of intra-uterine infection (chorioamnionitis or postpartum endometritis) treated with antibiotics, ruptured uterus at the time of delivery, received a postpartum tubal ligation or immediate postpartum IUD or implant at delivery, incarcerated women or women with significant cognitive impairment, 4th degree perineal laceration sustained at delivery, any medical contraindication to IUD per the US CDC Medical Eligibility Criteria, any suspicion for new pregnancy.  

Sarah Averbach, MD
Sarah Averbach, MD, MAS
Clinician Knowledge and Beliefs About Rh testing in Early Pregnancy To assess baseline clinician knowledge regarding Rh testing in early pregnancy and understand barriers impeding practice changes regarding Rh testing in early pregnancy. (Inclusion): ObGyn Clinicians in academic medical settings Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
Patient Experience Regarding Seeking Permanent female Contraception and Technology Influences (PERSPeCTIves) To describe motivations, influences, barriers, impact of abortion restrictions, and technology use for nulliparous patients under the age of 30 seeking permanent femal contraception. (Inclusion): Clinicians who see patients seeking permanent female contraception. Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
University of California Abortion Registry (UCAR): an initial assessment of high risk pregnancies and surgical abortion complications To better understand the abortion risk profile for women with high-risk pregnancies. A collaboration with other UC medical centers.

(Inclusion): 18 years or older; Less than 23 weeks and 6 days; Having had one of the following ICD-10 procedures (59840, 59841, 59820, 59821)

(Exclusion): If they underwent an induction termination or a medication abortion; If they underwent admission or procedure as a result of an outside facility transfer

Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
The Impact of Dobbs v. Jackson on Obstetrics and Gynecology Resident Abortion Training To assess the effect of the Dobbs decision on OBGYN residency abortion training
in the United States from the perspective of Ryan Residency directors and Residency Program Directors.
(Inclusion): Directors of ob/gyn residency programs Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
Assessing Interest in peer Doula-facilitated Empathy and Self-compassion Training among women with history of Early Pregnancy Loss (AIDES for EPL) To assess the potential for a peer support doula (trained in pain management, self-compassion, and emotional support techniques) as a possible early pregnancy loss (EPL) intervention that could result in improved emotional wellbeing and ability to cope post-EPL (Inclusion): reproductive aged women 18-50 years old who experienced an EPL in the past two years and are able to consent in English Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
EXPLORING EQUITY AND PERSON-CENTERED CARE IN THE PROVISION OF CONTRACEPTION THROUGH TELEMEDICINE AMONG PATIENTS WHO SPEAK SPANISH: A MIXED-METHOD STUDY To explore telemedicine for contraception care, focusing on the experience of patients who speak Spanish. Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
Perspectives on Implementation of Extended Use of Long-acting Reversible Contraception (The PIE Study) Exloration of barriers and facilitators of IUD extended use from patient and clinician perspectives. Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
Phase 3 double-blind placebo-controlled efficacy trial of EVO100 vaginal gel for the prevention of urogenital Chlamydia trachomatis and Neisseria gonorrhoeae infection Phase 3 trial of a investigational gel to prevent transmission of gonhorrhea and chlamydia. Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
KEEP Contraceptive Arm Long acting-iMplant (CALM) AND CARRY ON To understand barriers, facilitators, and experiences of clinicians, patients, and health systems to implement and utilize extended use of the contraceptive implant.

(Inclusion): Over 18. Nexplanon user. Has appointment to replace nexplanon.

(Exclusion): Has had nexplanon for less that 32 months or more than 40 months.

Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
Assessment of Contraceptive Safety and Efffectiveness in Cystic Fibrosis This multi-site study linked Contraception method use with the national Cystic Fibrosis patient registry. Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
MENstrual Symptom Tracking to Understand and Assess (Women)Living with Cystic Fibrosis In this study we had participants track their menstrual cycle & Cystic Fibrosis symptoms in the same App to see if there an association. Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
Retrospective Evaluation of Predictors of Maternal-Fetal Outcomes in Cystic Fibrosis In this multi-site study we retrospectively looked pregnancy outcome & Cystic Fibrosis (CF) symptom severity among individuals with CF. Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
Addition of Buprenorphine to Paracervical Block Prior to Osmotic Dilator Insertion for Dilation and Evacuation: A Randomized Controlled Trial RCT study. We evaluated whether Buprenorphine added to paracervicel block made a difference in patients' perceptions of pain during dilator insertion. Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
Partnering with Refugee Women to Inform Culturally Sensitive Patient-Centered Reproductive Healthcare We partnered with refugee women from East Africa and Middle East to learn what type of reproductive health care information would be most helpful to their communities. Sheila Mody, MD, MPH
Sheila Mody, MD, MPH
Depot medroxyprogesterone acetate (DMPA) use in women with and without epilepsy: a pilot study of serum MPA levels We drew blood samples from our patients with epilepsy who are DMPA users to evaluate how their epilepsy medications interact with their levels of DMPA. (Inclusion): Diagnosis of epilepsy, current user of DMPA Sheila Mody, MD, MPH
Sheila Mody, MD, MPH

Division of Gynecologic Oncology

Gynecologic Oncology Clinical Studies at UCSD

Study Title Description Eligibility Contact Location
Acrivon ACR-368-201/GOG-3082: A Phase 1b/2 Basket Study of ACR-368 as Monotherapy and in Combination with Gemcitabine in Adult Subjects with Platinum-Resistant Ovarian Carcinoma, Endometrial Adenocarcinoma, and Urothelial Carcinoma Based on Acrivon OncoSignature Status This study is examining the use of ACR-368 in patients with platinum resistant recurrent ovarian cancer. The trial is trying to also determine the potential utility of an OncoSignature on predicting response to treatment Ramez Eskander, MD
Ramez Eskander, MD
Corcept: GOG-3073 CORT125134-556: A Phase 3 Study of Relacorilant in Combination with Nab-Paclitaxel versus Nab-Paclitaxel Monotherapy in Advanced, Platinum-Resistant, High- Grade Epithelial Ovarian, Primary Peritoneal, or Fallopian-Tube Cancer (ROSELLA) Preliminary evidence suggests that glucocorticoid receptor antagonists, when combined with chemotherapy can improve outcomes in patients with platinum resistant recurrent ovarian cancer. This trial is examining the potential benefit of combining Relacorilant with Nab-Paclitaxel in platinum resistant recurrent ovarian cancer. Ramez Eskander, MD
Ramez Eskander, MD
Nuvectis GOG-3087 / ENGOT-GYN5 / NCRI / NXP800-101: A Phase 1 Clinical Study of NXP800 in Subjects with Advanced Cancers and Expansion in Subjects with Ovarian Cancer Clear cell and endometrioid ovarian cancers are difficulct to treat malignancies. This trial is examining a novel drug, NXP-800 in the treatment of ARID1a mutated clear cell and endometrioid ovarian cancer. Ramez Eskander, MD
Ramez Eskander, MD
Merck MK3475-C93: A Phase 3 Randomized, Open-label, Active-comparator Controlled Clinical Study of Pembrolizumab versus Platinum Doublet Chemotherapy in Participants With Mismatch Repair Deficient (dMMR) Advanced or Recurrent Endometrial Carcinoma in the First-line Setting (KEYNOTE-C93/GOG-3064/ENGOT-en15) THIS TRIAL IS CLOSED TO ACCRUAL Ramez Eskander, MD
Ramez Eskander, MD
CanariaBio. QPT-ORE-005 / GOG Foundation No. GOG-3035 (Flora-5): A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Clinical Study comparing Chemo-Immunotherapy (Paclitaxel-Carboplatin-Oregovomab) versus Chemotherapy (Paclitaxel-Carboplatin-Placebo) In Patients with Advanced Epithelial Ovarian, Fallopian Tube or Peritoneal Carcinoma THIS TRIAL IS CLOSED TO ACCRUAL Ramez Eskander, MD
Ramez Eskander, MD
UCSD IIT: Molecular and Epigenetic Profiling of Endometrial Cancer TISSUE COLLECTION STUDY Ramez Eskander, MD
Ramez Eskander, MD
Xencor XmAb20717-05: A Phase 2 Study of XmAb®20717 in Patients With Selected Gynecological Malignancies and High-Risk Metastatic Castration-Resistant Prostate Cancer Immunotherpay remains an attractive treatment option for many cancer types. This trial is examining a novel, bi-specific immunotherapy drug, XmAb20717, in patients with gynecologic malignancies Ramez Eskander, MD
Ramez Eskander, MD
GOG Foundation No. GOG-3043: A Randomized Controlled Trial of Robotic versus Open Radical Hysterectomy for Cervical Cancer (ROCC trial) This clinical trial is looking to determine if the robotic laparoscopic platform is safe in the surgical management of appropriately selected cervical cancer patients. Ramez Eskander, MD
Ramez Eskander, MD
K-Group Beta ZN-c3-005 / GOG-3066: A Phase 2 Open-Label, Multicenter Study to Evaluate Efficacy and Safety of ZN‑c3 in Subjects with High-Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Wee-1 inhibitors have shown proise as treatment strategies in the management of platinum resistant, recurrent ovarian cancer.  This trial is looking to examine the efficacy of ZN‑c3, a wee-1 inhibitor, in platinum resistant recurrent ovarian cancer Ramez Eskander, MD
Ramez Eskander, MD
Corcept: Mersana: MER-XMT 1536-3 / GOG-3049: A Phase 3, Randomized, Double-blind, Placebo-controlled, Multicenter Study of Upifitamab Rilsodotin (XMT-1536) as Post-Platinum Maintenance Therapy for Participants with Recurrent, Platinum-Sensitive Ovarian Cancer (UP-NEXT) THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
ImmunoGen: IMGN853-0420: Multicenter, open-label, phase 2 study of carboplatin plus mirvetuximab soravtansine followed by mirvetuximab soravtansine continuation in folate receptor-alpha positive, recurrent platinum-sensitive, high-grade epithelial ovarian, primary peritoneal, or fallopian tube cancers following 1 prior line of platinum-based chemotherapy Antibody drug conjugates have emerged as an appealing treatment strategy in the management of ovarian cancer. Mirvetuximab is already approved in FR-alpha high recurrent, platinum resistant ovarian cancer. This trial is examining the potential use of mirvetuximab in combination with carboplatin in patients with lower FR-alpha expression levels. Ramez Eskander, MD
Ramez Eskander, MD
ImmunoGen: GOG-3078 IMGN853-0421: Randomized, multicenter, open-label, phase 3 study of mirvetuximab soravtansine in combination with bevacizumab versus bevacizumab alone as maintenance therapy for patients with FRα-positive recurrent platinum-sensitive epithelial ovarian, fallopian tube, or primary peritoneal cancers who have not progressed after second line platinumbased chemotherapy plus bevacizumab (GLORIOSA) Antibody drug conjugates have emerged as an appealing treatment strategy in the management of ovarian cancer. Mirvetuximab is already approved in FR-alpha high recurrent, platinum resistant ovarian cancer. This trial is examining the potential use of mirvetuximab in combination with bevacizumab as a maintenance treatment in patients with FR alpha high, recurrent platinum sensitive ovarian cancer Ramez Eskander, MD
Ramez Eskander, MD
NRG-GY018: A Phase III Randomized, Placebo-Controlled Study of Pembrolizumab (MK-3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
Merck KEYNOTE-B21 / ENGOT-en11 / GOG-3053: A Phase 3, Randomized, Double-Blind Study of Pembrolizumab versus Placebo in Combination With Adjuvant Chemotherapy With or Without Radiotherapy for the Treatment of Newly Diagnosed High-Risk Endometrial Cancer After Surgery With Curative Intent THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
NRG-GY014: A Phase II Study of Tazemetostat (EPZ-6438) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
Clovis CO-3810-101: A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With an Advanced, Metastatic Solid Tumor THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
Novocure ENGOT-ov50 / INNOVATE-3, EF-28 / GOG-3029: Pivotal, randomized, open-label study of Tumor Treating Fields (TTFields, 200kHz) concomitant with weekly paclitaxel for the treatment of recurrent ovarian cancer THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
A Phase II Randomised, Multi-Centre Study to Investigate the Efficacy and Tolerability of a Second Maintenance Treatment in Patients with Platinum-Sensitive Relapsed Epithelial Ovarian Cancer, who havePreviously Received PARP Inhibitor Maintenance Treatment THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
Patients with Ovarian Cancer Experiencing the Highest Benefit from Heated Intraperitoneal Chemotherapy (HIPEC) based on their Tumor-Intrinsic Chemosensitivity (KELIM) This is a retrospective study looking to examine the potential benefit of Heated Intraperitoneal Chemotherapy (HIPEC) based on their Tumor-Intrinsic Chemosensitivity (KELIM) Ramez Eskander, MD
Ramez Eskander, MD
The efficacy of platinum-based therapy in recurrent endometrial cancer patients who have received prior platinum: Does the paradigm of platinum sensitivity apply in the Endometrial cancer space? Ramez Eskander, MD
Ramez Eskander, MD
A Phase 1b/2, Open-Label Study to Evaluate the Safety and Efficacy of Lucitanib in Combination With Nivolumab in Patients With an Advanced, Metastatic Solid Tumor THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
Loop electrosurgical excision procedure in the outpatient vs inpatient setting This is a retrospective study exploring the clinical outcomes for in patient vs out patient LEEP Ramez Eskander, MD
Ramez Eskander, MD
MMR deficiency in high-intermediate risk endometrial cancer and outcomes based on adjuvant therapy THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
Effects of proactive oncology dietetics care on weight and body composition during treatment of patients with locally advanced cervical cancer (LACC) undergoing primary chemoradiation (CRT): a pilot study THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
Assessment of Malnutrition and its implications on outcomes in patients with Cervical, Vulvar and Vaginal Cancer Receiving Definitive Chemoradiation THIS STUDY IS CLOSED Ramez Eskander, MD
Ramez Eskander, MD
A retrospective analysis of combination pegylated liposomal doxorubicin andbevacizumab use in women with recurrent endometrial cancer. Steven Plaxe, MD
Steven Plaxe, MD
NRG-GY004: A Phase III Study Comparing Single-Agent Olaparib or the Combination of Cediranib and Olaparib to Standard Platinum-Based Chemotherapy in Women with Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Michael McHale, MD
Michael McHale, MD
GeneLux / GOG-3076 / Olvi-Vec-022: A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec followed by Platinum-doublet Chemotherapy and Bevacizumab Compared with Platinum-doublet Chemotherapy and Bevacizumab in Women with Platinum-Resistant/Refractory Ovarian Cancer (OnPrime) Michael McHale, MD
Michael McHale, MD
Alkermes: ALKS 4230-007 / GOG-3063 / ENGOT-ov68: A Phase 3, Multicenter, Open-Label, Randomized Study of Nemvaleukin Alfa in Combination With Pembrolizumab Versus Investigator’s Choice Chemotherapy in Patients With Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (ARTISTRY-7) Michael McHale, MD
Michael McHale, MD
The impact of myometrial invasion in stage 1 carcinosarcomas (Study # 805830) Michael McHale, MD
Michael McHale, MD
GOG-0286B A Randomized Phase II/III Study Of Paclitaxel/Carboplatin/Metformin (NSC#91485) Versus Paclitaxel/Carboplatin/Placebo As Initial Therapy For Measurable Stage III Or IVA, Stage IVB, or Recurrent Endometrial Cancer Michael McHale, MD
Michael McHale, MD
K-Group Beta ZN-c3-002 / GOG-3072: A Phase 1b Study of ZN-c3 in Combination with Chemotherapy in Patients with Platinum-Resistant Ovarian, Peritoneal, or Fallopian Tube Cancer Michael McHale, MD
Michael McHale, MD
Preoperative COVID 19 testing- feasibility, testing results and patient outcomes (Study # 200598) Michael McHale, MD
Michael McHale, MD
AstraZeneca D9311C00001; GOG-3041; ENGOT-EN10 (DUO-E): A Randomised, Multicentre, Double-blind, Placebo-controlled, Phase III Study of First-line Carboplatin and Paclitaxel in Combination with Durvalumab, Followed by Maintenance Durvalumab with or without Olaparib in Patients with Newly Diagnosed Advanced or Recurrent Endometrial Cancer Michael McHale, MD
Michael McHale, MD
Agenus C-750-01/GOG-3028 A Two-arm, Randomized, Non-comparative, Phase 2 Trial of AGEN2034 (anti-PD-1) as a Monotherapy or Combination Therapy with AGEN1884 (anti-CTLA4) or with Placebo in Women with Recurrent Cervical Cancer (Second Line) - RaPiDS Michael McHale, MD
Michael McHale, MD
A Randomized Phase II Study Comparing Single-Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer. IND# 137760 Michael McHale, MD
Michael McHale, MD
GOG 0258: A Randomized Phase III Trial of Cisplatin and Tumor Volume Directed Irradiation Followed by Carboplatin and Paclitaxel vs. Carboplatin and Paclitaxel for Optimally Debulked, Advanced Endometrial Carcinoma Michael McHale, MD
Michael McHale, MD
GOG-0238: A Randomized Trial Of Pelvic Irradiation With Or Without Concurrent Weekly Cisplatin In Patients With Pelvic-Only Recurrence Of Carcinoma Of The Uterine Corpus Michael McHale, MD
Michael McHale, MD
NCI 10104: A Randomized Phase 2 Study of Cabozantinib in Combination with Nivolumab in Advanced, Recurrent, Metastatic Endometrial Cancer Michael McHale, MD
Michael McHale, MD
Iovance C-145-04: A Phase 2, Multicenter Study to Evaluate the Efficacy and Safety Using Autologous Tumor Infiltrating Lymphocytes (LN-145) in Patients with Recurrent, Metastatic, or Persistent Cervical Carcinoma Michael McHale, MD
Michael McHale, MD
UCSD IIT ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer with Kinase Inhibition of FAK Michael McHale, MD
Michael McHale, MD
NCI 9944: Phase 2 Study of VX-970 (NSC# 780162) in Combination with gemcitabine versus gemcitabine alone in Subjects with Platinum-Resistant Recurrent Ovarian or Primary Peritoneal Fallopian Tube Cancer (NCI) Michael McHale, MD
Michael McHale, MD
GOG-0225: Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival? Michael McHale, MD
Michael McHale, MD
UCSD IIT BRCA1-IRIS: Expression Induced in Ovarian Cancer by Treatment with Platinum-Based Chemotherapy and the Development of Platinum Resistance Correlates with the Induction of BRCA1-IRIS Expression Cheryl Saenz, MD
Cheryl Saenz, MD
UCSD IIT: Early Detection of Ovarian Cancer through Identification of Ovarian Cancer Biomarkers using Dielectropheresis (DEP) Based Chip Technology Cheryl Saenz, MD
Cheryl Saenz, MD
UCSD IIT: Molecular Profiling of Ovarian Carcinomas Cheryl Saenz, MD
Cheryl Saenz, MD

Division of Maternal-Fetal Medicine

Maternal-Fetal Medicine Clinical Trials at UCSD

Study Title Description Eligibility Contact Location
Twin gestations and mode of delivery: predictors of successful vaginal delivery and maternal and neonatal outcomes by planned and actual mode of delivery Jerasimos Ballas, MD Clinical Investigator
Jerasimos Ballas, MD
Evidence-Based Prediction and Prevention of Adverse Outcomes Caused by Postpartum Hypertension Ukachi Emeruwa, MD Clinical Investigator
Ukachi Emeruwa, MD, MPH
Obstetrical and Intrapartum Factors Associated with Successful versus Failed or Complicated Induction Trial of Labor After Cesarean This study seeks to identify maternal and intrapartum factors associated with successful versus failed induction TOALC, and with induction TOLAC compilations, among women undergoing induction TOLAC. An examination of the maternal and obstetrical factors among women undergoing induced TOLAC which are associated with successful outcomes will allow clinicians to stratify which patients are good candidates for induction TOLAC, providing them with the benefits of TOLAC, while sparing other women from the risks of failed or complicated TOLAC.

(Inclusion): persons with a prior cesarean section undergoing an induction of labor either electively or for medical indication after 34 weeks with a live, singleton gestation in cephalic presentation.

(Exclusion): persons with multiple gestation, fetal demise, malpresentation, contraindication to vaginal delivery, those who present with spontaneous labor, cases of labor augmentation, those who undergo planned elective repeat cesarean section, or for whom available data is insufficient.

Cynthia Gyamfi-Bannerman, MD, MS Clinical Investigator
Cynthia Gyamfi-Bannerman, MD, MS
Labor Agentry and Postpartum Mental Health in the Setting of High Risk Pregnancy This study aims to evaluate the relationship between postpartum mental health and wellbeing and perceived control over delivery (labor agentry). Subjects will be enrolled early in the third trimester and given surveys to complete at on enrollment, immediately after delivery, and at 6 weeks postpartum.

(Inclusion): Patients must be 28-32 weeks gestational age, English or Spanish speaking, over 18 years old, not planning on a cesarean delivery, and see high risk OB (MFM) for prenatal care.

(Exclusion): Planning a cesarean section, under 18, primary language other than English or Spanish, see a prenatal provider who is not a high risk OB

Cynthia Gyamfi-Bannerman, MD, MS Clinical Investigator
Cynthia Gyamfi-Bannerman, MD, MS
Promoting Shared Decision Making in Periviable Care: A randomized controlled trial of the Periviable GOALS Decision Support Tool To test the Periviable GOALS (Getting Optimal Alignment around Life Support) decision support tool versus usual care among pregnant women who are hospitalized for potential periviable delivery.

(Inclusion):

  • 18 years of age or older
  • At risk for delivery between GA 22.0-23.6
  • Counseled by NICU and MFM regarding resuscitation options
Cynthia Gyamfi-Bannerman, MD, MS Clinical Investigator
Cynthia Gyamfi-Bannerman, MD, MS
Childhood Pulmonary Complications in a Birth Cohort after a Randomized Trial of Antenatal Corticosteroids: the ALPS Follow-Up Study There is little information on long-term pulmonary outcomes of children born in the late preterm period, and no data on the effects of antenatal betamethasone exposure when administered in the late preterm period. Therefore, this study is designed to conduct an assessment of pulmonary outcomes on children whose mothers participated in the MFMU Network ALPS trial to determine whether the neonatal benefit of antenatal corticosteroids is sustained into childhood. Cynthia Gyamfi-Bannerman, MD, MS Clinical Investigator
Cynthia Gyamfi-Bannerman, MD, MS
COVID-19 and Pregnancy Outcomes with Extracorporeal Membrane Oxygenation (CPrO-ECMO) Observational study regarding the use of Extracorporeal Membrane Oxygenation system for COVID-19 infection in pregnancy Cynthia Gyamfi-Bannerman, MD, MS Clinical Investigator
Cynthia Gyamfi-Bannerman, MD, MS
MIRACLE of LIFE Study: Observational Study of Pregnant Women to Validate Biomarkers of Pregnancy Complication Risk Development of a blood test to identify maternal plasma markers that are predictive of fetal age and pregnancy complications like preterm birth and preeclampsia. Cynthia Gyamfi-Bannerman, MD, MS Clinical Investigator
Cynthia Gyamfi-Bannerman, MD, MS
Prematurity Risk assessment combined with clinical Interventions for improving neonatal outcoMEs (The PRIME Study) The PreTRM test is a blood test that lookds at certain proteins in the blood and predicts the risk of giving birth preterm (<37wk GA). All women will have blood collected but only half will receive the test result. Those who get a Higher risk result will be offered the intervention.

(Inclusion):

  • 18 years of age or older
  • Gestational age18 0/7 to 20 6/7 weeks
  • Singleton intrauterine pregnancy
  • No signs and/or symptoms of preterm labor and has intact membranes
Cynthia Gyamfi-Bannerman, MD, MS Clinical Investigator
Cynthia Gyamfi-Bannerman, MD, MS
Oral fat tolerance testing for prediction of preeclampsia This study aims to evaluate the feasibility and utility of an oral lipid challenge test between 16-24 weeks gestation to predict development of preclampsia in high risk patients. The study involves ingestion of an oral lipid challenge drink with 3 timed blood draws (BL, 1hr, 4hr) and brief diet and exercise surveys. Marni Jacobs, PhD
Marni Jacobs, PhD
Pre and post-natal evaluation of CPAM The aim of this study is to examine characteristics of pre and post-natal imaging that may be used to predict adverse outcomes and to compare the performance and pre and post natal imaging for diagnosis and prognostication of these conditions. Leah Lamale Smith, MD Clinical Investigator
Leah Lamale-Smith, MD
Education Intervention Study Design: Obstetric Laceration Identification and Categorization This study will allow research to be done using data from imaging examinations that have been or will be performed for clinical care and compare to outcomes identified from medical records. Leah Lamale Smith, MD Clinical Investigator
Leah Lamale-Smith, MD
Prospective and Retrospective observational Study in Human Subjects Undergoing Imaging Examinations in Pregnancy Obstetric laceration identification and categorization: in this study, we examine whether we can improve obstetric laceration identification and diagnosis with a brief instructional video. Leah Lamale Smith, MD Clinical Investigator
Leah Lamale-Smith, MD
Multi-Omics for Maternal Health after Preeclampsia (MOM-Health) To develop strategies to identify postpartum women at risk for adverse cardiovascular outcomes and provide them with preventative therapies. Participation in the study will begin no later than the second trimester of pregnancy (enrollment by 24 weeks of gestation) and continue through the first year postpartum. Over the course of the study, biospecimens and relevant surveys and cardiovascular assessments will be collected at specified intervals/time-points.

(Inclusion):

  • Pregnant women 18 years of age to 50 years of age
  • 10-24 weeks gestation at time of enrollment
  • Singleton pregnancy
  • Planning to deliver at a study site

(Exclusion):

  • Inability to give informed consent
  • Intrauterine fetal demise
  • Fetal genetic or structural anomaly
  • Institutionalization for psychiatric disorder, mental deficiency or incarcerated
  • Active or history of malignancy requiring major surgery or systemic chemotherapy
  • Multi-fetal gestation or a twin demise at any gestational age
  • Known maternal or fetal chromosomal anomalies
  • Patients who plan to keep their placenta after delivery
Louise Laurent, MD, PhD Clinical Investigator
Louise Laurent, MD, PhD
CO-CREATE-Ex: Community-engaged Optimization of COVID-19 Rapid Evaluation And TEsting Experiences The purpose of this study is to offer sustainable COVID-19 testing convenience in the greater San Diego community. This will be a flexible and sustainable approach that promotes responsiveness to both the needs of the community and the changing pandemic context while reducing COVID-19 disparities.

(Inclusion):

  • Age 18 years or older
  • Speak Spanish or English
  • Cohort 2 Testing Group:
  • Speak Spanish and/or English.
  • Affiliated with San Ysidro Health as a patient at select clinics (San Ysidro, Chula Vista, Lincoln Park, and Logan Heights) OR
  • A member of a community near a SYH clinic (San Ysidro, Chula Vista, Lincoln Park, and Logan Heights).
  • Ages 2 and older (for use of FDA-authorized antigen test kits)
  • Cohort 3 Healthcare Providers/Staff/Administrators:
  • Speaks Spanish and/or English.
  • Employed as a SYH clinical provider, administrator, or clinical staff member at a participating clinic
Louise Laurent, MD, PhD Clinical Investigator
Louise Laurent, MD, PhD
Uncovering the etiologies of non-immune hydrops fetalis through comprehensive genomic analyses and phenotyping This is a multicenter collaboration designed to discover genetic diseases and novel variants underlying non-immune hydrops fetalis (NIHF) and other fetal effusions in a prospectively cohort utilizing genomic sequencing and RNA sequencing.

(Inclusion): Non-diagnostic results of chromosomal microarray and/or karyotype and No evidence of:

  • Clinically significant abruption that is suspected to underlie NIHF
  • Twin-twin transfusion syndrome in monochorionic twins;
  • Clear fetal viral infection;
  • Alloimmunization.

AND ONE OF THE FOLLOWING

  • i) Increased nuchal translucency or cystic hygroma ≥5 mm WITHOUT any additional fetal effusions or anomalies;

AND/OR

  • ii) Increased nuchal translucency or cystic hygroma ≥3.5 mm AS WELL AS either any additional fetal effusions or congenital anomalies;

AND/OR

  • iii) Fetal ascites, pleural effusion, pericardial effusion, AND/OR skin edema identified at any point during gestation, prior to the conclusion of the pregnancy.
Louise Laurent, MD, PhD Clinical Investigator
Louise Laurent, MD, PhD
Prospective NIPT Sample Collection The purpose of this study is to collect blood samples from volunteers to develop a new noninvasive prenatal test that can detect these genetic abnormalities in blood samples.

(Inclusion):GA≥10Wks, available results form NIPT standard

(Exclusion):Failure to meet inclusion criteria

Louise Laurent, MD, PhD Clinical Investigator
Louise Laurent, MD, PhD
Non-Invasive Continuous Fetal Monitoring in Obstetric Patients To demonstrate the use of a non-invasive, wearable continuous fetal hemodynamics monitor. The long-term goal is to apply this system for at-home monitoring, which will allow clinicians to properly assess and manage response to treatment in fetal complications such as hypoxia, growth restrictions, or pre-eclampsia.

(Inclusion):

  • Female age ≥18 years of age
  • Able to provide informed consent
  • Fetal gestational age 24-42 weeks at time of consent
  • Surrogates and/or use of donor eggs/donor sperm for conception is allowed
Louise Laurent, MD, PhD Clinical Investigator
Louise Laurent, MD, PhD
Obtaining Umbilical Cords for Clinical and Non-Clinical Research The purpose of this study is to collect tissue samples for Angiocrine Bioscience, who will then perform research to determine the potential for cells isolated from the umbilical cord tissue to regenerate cells within the hematologic (blood) system and to repair various tissues and organs in the body that are damaged by disease.

(Inclusion):

  • Female age >18 years of age
  • Able to provide informed consent
  • Able to provide acceptable answers to Donor/Subject Questionnaire
  • Giving birth at a licensed hospital-based Labor and Delivery (L&D) Unit
  • Neonatal gestational age 24-42 weeks at time of consent
  • History of prolonged rupture of membranes with no maternal fever before birth is allowed
  • History of maternal diabetes or hypertension is allowed
  • Surrogates and/or use of donor eggs/donor sperm for conception is allowed
  • Multiple gestation pregnancy is allowed
Louise Laurent, MD, PhD Clinical Investigator
Louise Laurent, MD, PhD
Prenatal and placental evaluation of high risk obstetric patients The purpose of this study is to determine if certain ultrasound findings, clinical data and biomarkers present in biospecimens such as urine, blood and placenta can help predict the outcome of pregnancy. A biospecimen bank and associated database have been created under this protocol and will be used for biomarker discovery and/or validation. Placental stem cells will be used for investigation of the different cell types that are made during embryo and placental development and will be used to study placental dysfunction.

(Inclusion):

  • Pregnant patients ≥ 18 years of age.
  • Agrees to allow for the placenta to be sent to Pathology for evaluation.

Inclusion criteria for the Non-pregnant group:

  • Non-pregnant women ≥ 18 years of age.
  • Healthy women with no previous history of chronic hypertension or renal disease.
Louise Laurent, MD, PhD Clinical Investigator
Louise Laurent, MD, PhD
Biomarkers predicting onset of spontaneous term labor This project will look at changes in levels of biomarkers (e.g. exRNAs and proteins) in biofluid samples collected from pregnant women from 38 to 42 weeks gestation. We will analyze these data to identify biomarkers to predict when a woman will go into labor. GA 38.0 to 38.3; singleton pregnancy; healthy women with no previous poor pregnancy outcome Louise Laurent, MD, PhD Clinical Investigator
Louise Laurent, MD, PhD
Discovery of maternal circulating biomarkers to distinguish between normal placentation, placenta previa and placenta accreta The purpose of this study is to determine whether circulating biomarkers in the maternal blood, with or without specific ultrasound findings and clinical data, can accurately distinguish pregnancies affected by placenta accreta from pregnancies affected by placenta previa (placenta covering the cervix) without accreta and from pregnancies with normally located placentas. A biospecimen bank and associated database will be created under this protocol and will be used for biomarker discovery and/or validation.

Inclusion criteria for cases:

  • Pregnant women ≥18 years of age
  • Presenting for care in one of the listed health care systems
  • Diagnosis of suspected placenta accreta, diagnosed by ultrasound or magnetic resonance imaging
  • Planning to deliver within the listed health care system
  • Agrees to allow for the placenta to be sent to Pathology for evaluation
Louise Laurent, MD, PhD Clinical Investigator
Louise Laurent, MD, PhD
App-based glucose logs for gestational diabetes mellitus: a multicenter randomized clinical trial Evaluate outcomes associated with the use of an app-based glucose log versus traditional pen and paper for management of GDM.

(Inclusion): Diagnosis of GDM in pregnancy

(Exclusion): Pre-existing diabetes, use of APP independently

Sandy Ramos, MD, Clinical Investigator
Sandy Ramos, MD
Continuous glucose monitoring in non-diabetic laboring women Characterize glucose utilizing CGM in pregnant people without diabetes Sandy Ramos, MD, Clinical Investigator
Sandy Ramos, MD
Pilot Study to Assess Adherence to Daily Low Dose Aspirin in Pregnant Patients with Pre-Gestational Diabetes Assess compliance with Aspirin in a population of people with diabetes mellitus in pregnancy Sandy Ramos, MD, Clinical Investigator
Sandy Ramos, MD
A comparison of continuous glucose monitor (CGM) to traditional glucometer readings during admission for delivery in women with type 1 diabetes mellitus (T1DM) Assess correlation between glucose obtain utilizing glucometer versus CGM Sandy Ramos, MD, Clinical Investigator
Sandy Ramos, MD
Medical Optimization & Management of Pregnancies with Overt Type 2 Diabetes (MOMPOD), A Multicenter Trial Evaluation pregnancy and neonatal outcomes with Metformin added to insulin for management of Diabetes in pregnancy Sandy Ramos, MD, Clinical Investigator
Sandy Ramos, MD

Division of Reproductive Endocrinology and Fertility

Reproductive Endocrinology and Infertility Clinical Studies

Study Title Description Eligibility Contact Location
Quantitative proteomic profiling of extracellular vesicles from menstrual effluent for discovery of non-invasive diagnostic biomarkers of endometriosis Sanjay Agarwal, MD Clinical Investigator
Sanjay Agarwal, MD
Pilot study of the IL-1 antagonist anakinra for the treatment of endometriosis related symptoms Sanjay Agarwal, MD Clinical Investigator
Sanjay Agarwal, MD
Androgen effects on the reproductive neuroendocrine axis Evaluations of reproductive hormones and ovulation in transgender men before and during testosterone treatment; comparison with cisgender women Transgender men initiating therapy or cisgender women, age 18-35, BMI 18-29, no endocrinopathy Antoni Duleba, MD Clinical Investigator
Antoni Duleba, MD
Pulsatile Secretion of Luteinizing Hormone in Transgender Men and Cisgender Female Controls Evaluations of reproductive hormones and ovulation in transgender men before and during testosterone treatment; comparison with cisgender women Antoni Duleba, MD Clinical Investigator
Antoni Duleba, MD
Association of fertility preservation health insurance benefit mandates with utilization of ART banking and philanthropic fertility drug programs among females newly diagnosed with cancer Via linking the national IVF dataset (SART) with data from the Walgreens Heart Beat Program, we aim to compare utilization of ART oocyte and embryo banking prior to gonadotoxic treatment cycles and Heart Beat Program before and after the effective date of state fertility preservation mandates Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
The SAFE Study: Psychosocial Stress And Fertility Outcomes The objectives are: 1) Test the feasibility of ecological momentary assessment (EMA) to measure psychosocial stress in females with infertility, and 2) Estimate the association between psychosocial stress and follicular phase length and ovulation. (Inclusion): Ages 18-42, regular menstrual cycles, undergoing in vitro fertilization Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Navigating New UC IVF Benefits The objectives are: 1) Assess the feasibility, acceptability, appropriateness of and satisfaction with a health insurance education intervention on in vitro fertilization (IVF) insurance benefits; 2) Explore the effectiveness of a health insurance education intervention on health insurance literacy and IVF utilization. (Inclusion): University of California, San Diego staff or faculty, ages 18-50, intention to attempt pregnancy over the next year Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Telehealth oncofertility care: a stepped wedge cluster randomized controlled trial in pediatric, adolescent and young adult cancer survivors Conduct a hybrid type 1 effectiveness-implementation trial of a telehealth intervention for oncofertility care in three hospital systems (Inclusion): Ages 0-50, newly diagnosed cancer patient, oncology care at UC San Diego, Rady Children's or City of Hope Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Intervening on Women’s Health for Rural Young Breast Cancer Survivors Conduct an interrupted time series trial of a multi-component intervention to deliver women’s health care to rural breast cancer survivors (Inclusion): Ages 0-50, breast cancer survivor, female Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Ovarian tissue cryopreservation outcomes: a study by the Oncofertility Consortium This is a multi-center prospective cohort study following psychosocial and reproductive otucomes in individuals who undergo ovarian tissue cryopreservation for fertility preservation (Inclusion): Ages 0-42, undergoing ovarian tissue cryopreservation Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Implementation of fertility care for adolescents and young adults with cancer Conduct an interrupted time series trial of a reproductive health survivorship care plan for Hispanic, rural female survivors of adolescent and young adult cancer Ages 0-39, AYA cancer survivor, undergoing care at El Centro Regional Medical Center Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Predictors of Ovarian Insufficiency through Serial Exams (POISE) Study in Young Breast Cancer Survivors A prospective cohort study using biomarkers to predict ovarian function outcomes in young breast cancer survivors Ages 0-45, breast cancer, has uterus and at least one ovary Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Cell free RNA as non-invasive biomarkers of in vitro fertilization (IVF) outcomes Using spent media in IVF culture, this study sought to measure cell free RNA and relate biomarkers to IVF outcomes. (Inclusion): IVF with embryo culture Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Intervening on Reproductive Health in Young Breast Cancer Survivors (SCP-R) This clinical trial tested if a remotely-delivered survivorship care plan on estrogen deprivation symptoms, fertility concerns, contraception and sexual health improved reproductive outcomes in breast cancer survivors Ages 0-45, breast cancer Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
The Reproductive Window in Young Adult Cancer Survivors This prospective cohort study aimed to characterize the pattern of ovarian function post-treatment in adolescent and young adult cancer survivors. Ages 15-40, AYA cancer, female, has uterus and at least one ovary Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Ovarian reserve testing in female young adult cancer survivors This prospective cohort study aimed to test ovarian reserve in the pill-free week in AYA cancer survivors to see if we can measure ovarian reserve accurately without stopping combined hormonal contraception Ages 15-40, AYA cancer, female, has uterus and at least one ovary Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Assessing reproductive outcomes in young female cancer survivors through a national fertility preservation registry This prospective cohort study measured patient reported reproductive outcomes in a national cohort of female AYA cancer survivors Ages 15-40, AYA cancer, female Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Studying the impact of state-mandated health insurance benefits for fertility preservation services on affordability and access for Hispanic/Latino cancer patients Assess the association between social determinants of health and fertility preservation health insurance benefit designs and access. Ages 0-50, newly diagnosed cancer patient, oncology care at UC San Diego, Rady Children's or City of Hope Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Policy implementation research on health benefit mandates for fertility preservation services to improve access to care in young cancer survivors. To characterize multi-level implementation of state-level health insurance benefit mandates for fertility preservation (Inclusion): Newly diagnosed cancer patients, parents/guardians, oncology and fertility clinic members Irene Su, MD Clinical Investigator
H. Irene Su, MD, MSCE
Expression and Regulation of RHOX Genes and an X-linked MicroRNACluster EDeveloping a stem cell approach to confer fertility to infertile male patients. Spermatogonial stem cells (SSCs) are essential for the continuous generation of sperm. Thus, there is tremendous interest in generating a SSC-based therapy to treat male infertility. Two key challenges in developing SSC therapy are (i) the identification of specific markers that label human SSCs (so they can be identified and purified), and (ii) development of methods to culture human SSCs. We are actively working on both these challenges. In order to do so, it is essential we have testicular biopsies as a source of SSCs. Miles Wilkinson, PhD Clinical Investigator
Miles Wilkinson, PhD
Development of a Diagnostic PCR test for Semen Samples from Patients with Spermatogenic Arrest Optimizing a rapid diagnostic test—only requiring semen, not a testes biopsy—that will tell your doctor whether you have a spermatogenic defect and, if so, whether it is treatable. For example, if your semen has no sperm and our molecular diagnostic test indicates that you have “testicular sperm” (technically, called “elongated spermatids”), you will be a strong candidate for the microdissection testicular sperm extraction (mTESE) procedure. This mTESE procedure, coupled with intracytoplasmic sperm injection (ICSI), has the potential to allow you to father children. An added feature of the diagnostic test we are developing is that it will determine how “mature” your testicular sperm are. Mature testicular sperm are probably more likely than immature testicular sperm to fertilize an egg. Thus, our diagnostic test has the potential to predict the likelihood that you will father children through the mTESE + ICSI procedure. Miles Wilkinson, PhD Clinical Investigator
Miles Wilkinson, PhD

Division of Urogynecology and Reconstructive Pelvic Surgery

Urogynecology and Reconstructive Pelvic Surgery Trials at UCSD

Study Title Description Eligibility Contact Location
The Impact of Placental Extracellular Vesicles in Gestational Diabetes on Regeneration of Female Pelvic Skeletal Muscle After Birth Injury This study seeks to examine the composition of placental extracellular vesicles from different pregnancy conditions including obesity and gestational diabetes and their impact on pelvic floor skeletal muscle function and recovery from birth injury

Lindsey Burnett, MD, PhD
Lindsey Burnett, MD, PhD

Sponsor: Center for Perinatal Discovery

Clinical accuracy of the UDI and MESA questionnaries in defining type of urinary incontinence in a multi-lingual population: a retrospective cohort study. This study seeks to determine whether commonly used urinary questionnaires that have been validated in English are also useful at determining urinary symptoms in Spanish speaking patient populations. Lindsey Burnett, MD, PhD
Lindsey Burnett, MD, PhD

Beta-Agonist versus Botox A® Trial for Urgency Urinary Incontinence (BEST)

Discover "BEST" Research Study

The goal of this clinical trial is to compare treatment outcomes between an oral medication (beta agonist) versus onabotulinumtoxinA injections in women with urgency urinary incontinence (UUI).

Participants will be randomly selected to receive one of the two treatments. The primary outcome measure will be at 3 months, and women will be followed for a total of 12 months.

  1. 18 years or older
  2. report at least "quite a bit bothered" or worse by their UUI defined by response to OAB-q-SS item #8 "How bothered are you by urine loss associated with a strong desire to urinate?"
  3. are not and do not plan to become pregnant
  4. have persistent UUI defined as previous unsuccessful results after conservative and anticholinergic treatment, or are unable to tolerate or have contraindications to anticholinergics
  5. are currently not taking anticholinergics or are willing to stop medication for 3 weeks prior to enrollment.
  6. for participants reporting mixed urinary incontinence symptoms, participant must (a) have less bother from SUI than from UUI, defined as a response of "Not at all bothered" or only "a little bit bothered" by SUI on the Urogenital Distress Inventory item "Do you experience urine leakage related to physical activity? (walking, running, laughing, sneezing, coughing), and (b) SUI symptoms be stable (> 3 months), and (c)participant does not desire additional treatment for SUI in the upcoming 3 months.
  7. Participants after unsuccessful neuromodulation trial can be eligible after a 4-week washout period.

Emily Lukacz, MD, MAS
Emily Lukacz, MD, MAS

Sponsor: Patient-Centered Outcomes Research Institute (PCORI)

RISE FOR HEALTH

Discover "RISE" Clinical Trial

The RISE FOR HEALTH study (RISE) is an initiative of the Prevention of Lower Urinary Tract Symptoms (PLUS) Research Consortium, which was formed by the NIDDK in 2015 to develop the science to improve bladder health in women and girls. RISE is designed to identify risk and protective factors for bladder health and lower urinary tract symptoms (LUTS) and to estimate the distributions of bladder health and bladder health knowledge, attitudes, and beliefs in women of all ages across the life course.
  1. Community dwelling
  2. Age ≥18 years
  3. Identify or born as female (includes cis- and trans-women, and trans-men)
  4. Able to read and understand English or Spanish
  5. Able to read and provide informed consent

Emily Lukacz, MD, MAS
Emily Lukacz, MD, MAS

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health

PFDN Treatment for Mixed Urinary Incontinence: Mid-urethral Sling vs. Botox A (MUSA)

Discover "MUSA" Clinical Trial

The primary aim is to compare the effectiveness of intradetrusor injection of 100 unit injection of Botulinum toxin A to mid-urethral sling for change in MUI symptoms 6 months following treatment.
  1. Reporting at least "moderate bother" from UUI item on UDI "Do you experience urine leakage associated with a feeling of urgency?"
  2. Reporting at least "moderate bother" from SUI item on UDI "Do you experience urine leakage related to physical activity, coughing, or sneezing?"
  3. Diagnosis of SUI defined by a positive cough stress test (CST) or UDE within the past 18 months
  4. Presence of UUI on bladder diary with > 4 Urgency IE/3-day diary
  5. Urinary symptoms >3 months
  6. Persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, physical therapy) as determined adequate by the physician.
  7. Inadequate response to oral overactive bladder medications (including anti-cholinergic and/or beta-mimetic medication) unless patient is intolerant of oral overactive bladder medications, or oral overactive bladder medications are contraindicated as determined by the treating provider.
  8. Urodynamics within past 18 months
  9. Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.

Emily Lukacz, MD, MAS
Emily Lukacz, MD, MAS

Sponsor: NICHD Pelvic Floor Disorders Network

Three Arm Apical Suspension Trial for Post-Hysterectomy Vault Prolapse: Prospective Randomized Trial involving Sacral Colpopexy, Transvaginal Mesh and Native Tissue Apical Repair - The ASPIRe Study

Discover "ASPIRe" Clinical Trial

The study is a multi-center, randomized, surgical trial of women with symptomatic post-hysterectomy apical (cuff) prolapse desiring surgical treatment. This study will compare the three available surgical treatments performed in usual practice. The purpose of this study is to compare two commonly performed mesh apical repair (sacral colpopexy vs. Apical Transvaginal Mesh) and vaginal native tissue apical repairs with mesh reinforced repairs. The primary outcome is measured over time (up to 60 months) using a survival analysis approach.
  1. Women age 21 or older
  2. Prior total hysterectomy (no cervix present)
  3. Prolapse beyond the hymen (defined as Ba, C, or Bp > 0 cm)
  4. Vaginal cuff descent into at least the lower two thirds of the vagina (defined as point C> -2/3 TVL)
  5. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
  6. Desires surgical treatment for post-hysterectomy vaginal prolapse
  7. Available for up to 60 month follow-up

Emily Lukacz, MD, MAS
Emily Lukacz, MD, MAS

Sponsor: NICHD Pelvic Floor Disorders Network

PFDN 24P01 - A Randomized Trial of Vaginal Surgery for Uterovaginal Prolapse: Vaginal Hysterectomy with Native Tissue Vault Suspension vs. Mesh Hysteropexy Suspension - Study of Uterine Prolapse Procedures - Randomized Trial "SUPeR" Protocol Ver. 2.0

Discover "SUPeR" Clinical Trial

The primary purpose of this randomized clinical trial is to compare the effectiveness and safety of two transvaginal apical suspension strategies for uterovaginal prolapse: a mesh augmented hysteropexy versus vaginal hysterectomy and uterosacral ligament suspension (USLS). The primary aim is to determine whether treatment success in women who undergo the above strategies differ at time points through 3 years.
  1. Women aged 21 or older who have completed child-bearing
  2. Prolapse beyond the hymen (defined as Ba, Bp, or C > 0 cm)
  3. Uterine descent into at least the lower half of the vagina (defined as point C> -TVL/2) )
  4. Bothersome bulge symptoms as indicated on question 3 of the PFDI-20 form relating to 'sensation of bulging' or 'something falling out'
  5. Desires vaginal surgical treatment for uterovaginal prolapse
  6. Available for up to 60 month follow-up
  7. Amenorrhea for the past 12 months from either menopause or endometrial ablation
  8. Not pregnant, not at risk for pregnancy or agree to contraception if at risk for pregnancy (only applicable to the rare endometrial ablation patient)
  9. Eligible for no cervical cancer screening for at least 3 years

Emily Lukacz, MD, MAS
Emily Lukacz, MD, MAS

Sponsor: NICHD Pelvic Floor Disorders Network

CLEAR, Clarification of Language, Evaluation And Refinement of questions A Protocol for the Prevention of Lower Urinary Tract Symptoms (PLUS) Consortium

Discover "CLEAR" Clinical Trial

The primary objective of this study is to perform cognitive interviews in conjunction with an electronic survey to test candidate survey items for inclusion in a bladder health measure that can assess the full range of bladder health and be considered for further reliability and validity testing. The secondary objective is to carry out cognitive interviews/surveys to test key risk and protective factor candidate survey items capable of assessing risk and protective factors for bladder health.
  1. Female sex assigned at birth
  2. Fluent in written and spoken English (may be bilingual)
  3. Age ≥18 years old
  4. Available for a virtual 2 hours interview and questionnaire completion
  5. Able to read and provide either verbal or written informed consent
  6. Virtual interviews: Access to the computer with Internet, audio and video capabilities for participants who will be completing their Cis virtually

Emily Lukacz, MD, MAS
Emily Lukacz, MD, MAS

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health

A Randomized Trial of Transurethral Bulking Agent Injection versus Single-Incision Sling for Stress Urinary Incontinence: The BASIS Trial

Emily Lukacz, MD, MAS
Emily Lukacz, MD, MAS

Sponsor: NICHD, Pelvic Floor Disorders Network

Benchmarking storage and processing of the Urogenital Microbiome and Metabolomic Profile This study is designed to evaluate anonymous urine and vaginal samples collected from volunteers in clinic for shipping and storage conditions (e.g. extremes of temperature and duration of storage prior to analysis) and 16s vs. whole genome microbial sequencing of the urinary and vaginal microbiota (organisms, such as bacteria), and metabolites (the chemicals that the organisms make) in different preservative materials. Inclusion:
  1. Age ≥18 years
  2. Identify or born as female
Exclusion:
  1. Physical or mental condition that would impede participant to provide urine sample
Emily Lukacz, MD, MAS
Emily Lukacz, MD, MAS

Division of Obstetrics and Gynecology (Generalist)

Obstetrics and Gynecology Clinical Studies at UCSD

Study Title Description Eligibility Contact Location
Utilization of a low fidelity pelvic model in developing task-specific gynecologic surgical skills Jorge Alvarado, MD
Jorge Alvarado, MD
Exploring the association of introversion personality measures and third-year clinical clerkship evaluations David Klein, MD
David Klein, MD
Selecting Measures for a Maternal Equity Safety Bundle to Eliminate Racial Inequities Across Labor & Delivery Units in Massachusetts Audra Meadows, MD, MPH
Audra Meadows, MD, MPH
Reducing Racial Disparities in SMM Post COVID19: Assessing the Integration of Maternal Safety Bundles and Community Based Doulas to Improve Outcomes for Black Women Audra Meadows, MD, MPH
Audra Meadows, MD, MPH
Building and Evaluating an Introduction to Equity Focused Health Systems Science Course for Medical Students Audra Meadows, MD, MPH
Audra Meadows, MD, MPH
Reproductive Health Desires in a Refugee and Asylum Seeker Population in Tijuana, Mexico Maureen Ries, MD
Maureen Ries, MD
Post-menopausal bleeding: Incidence of fibroids as etiology of symptoms Shira Varon, MD
Shira Varon, MD
Effect of tourniquet time during myomectomy on ovarian reserve Shira Varon, MD
Shira Varon, MD
ULTRA (Uterine Leiomyomata Treatment with Radiofrequency ablation) Shira Varon, MD
Shira Varon, MD

Division of Hospitalist

Hospitalist Clinical Trials in Obstetrics and Gynecology at UCSD

Study Title Description Eligibility Contact Location
Outcomes After Obstetric Supracervical vs Total Hysterectomy: A Multi-Center Retrospective Chart Review Scott Harvey, MD
Scott Harvey, MD
Health Care Provider Experience During Virtual Reality Simulation in Obstetrics Hemorrhage Emergency Julia Cormano, MD
Julia Cormano, MD