Clinical Studies
Trailblazing research to discover better clinical outcomes in Obstetrics, Gynecology, and Reproductive Sciences
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Division of Complex Family Planning
Study Title | Description | Eligibility | Contact | Location |
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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. | |||
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, MAS |
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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, MAS |
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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, MAS |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
Division of Gynecologic Oncology
Study Title | Description | Eligibility | Contact | Location |
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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 |
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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 |
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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 |
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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 |
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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 |
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UCSD IIT: Molecular and Epigenetic Profiling of Endometrial Cancer | TISSUE COLLECTION STUDY | Ramez Eskander, MD |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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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 |
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MMR deficiency in high-intermediate risk endometrial cancer and outcomes based on adjuvant therapy | THIS STUDY IS CLOSED | Ramez Eskander, MD |
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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 |
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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 |
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A retrospective analysis of combination pegylated liposomal doxorubicin andbevacizumab use in women with recurrent endometrial cancer. | 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 | |||
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 | |||
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 | |||
The impact of myometrial invasion in stage 1 carcinosarcomas (Study # 805830) | 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 | |||
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 | |||
Preoperative COVID 19 testing- feasibility, testing results and patient outcomes (Study # 200598) | 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 | |||
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 | |||
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 | |||
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 | |||
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 | |||
NCI 10104: A Randomized Phase 2 Study of Cabozantinib in Combination with Nivolumab in Advanced, Recurrent, Metastatic Endometrial Cancer | 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 | |||
UCSD IIT ROCKIF Trial: Re-sensitization of Carboplatin-resistant Ovarian Cancer with Kinase Inhibition of FAK | 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 | |||
GOG-0225: Can Diet and Physical Activity Modulate Ovarian, Fallopian Tube and Primary Peritoneal Cancer Progression-Free Survival? | 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 | |||
UCSD IIT: Early Detection of Ovarian Cancer through Identification of Ovarian Cancer Biomarkers using Dielectropheresis (DEP) Based Chip Technology | Cheryl Saenz, MD | |||
UCSD IIT: Molecular Profiling of Ovarian Carcinomas | Cheryl Saenz, MD |
Division of Maternal-Fetal Medicine
Study Title | Description | Eligibility | Contact | Location |
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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 |
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Evidence-Based Prediction and Prevention of Adverse Outcomes Caused by Postpartum Hypertension | Ukachi Emeruwa, MD, MPH |
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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 |
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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 |
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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):
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Cynthia Gyamfi-Bannerman, MD, MS |
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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 |
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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 |
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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 |
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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):
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Cynthia Gyamfi-Bannerman, MD, MS |
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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 | ||
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 | ||
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 | ||
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 | ||
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):
(Exclusion):
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Louise Laurent, MD, PhD |
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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):
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Louise Laurent, MD, PhD |
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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:
AND ONE OF THE FOLLOWING
AND/OR
AND/OR
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Louise Laurent, MD, PhD |
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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 |
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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):
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Louise Laurent, MD, PhD |
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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):
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Louise Laurent, MD, PhD |
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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):
Inclusion criteria for the Non-pregnant group:
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Louise Laurent, MD, PhD |
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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 |
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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:
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Louise Laurent, MD, PhD |
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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 | |
Continuous glucose monitoring in non-diabetic laboring women | Characterize glucose utilizing CGM in pregnant people without diabetes | 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 | ||
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 | ||
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 |
Division of Reproductive Endocrinology and Fertility
Study Title | Description | Eligibility | Contact | Location |
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Quantitative proteomic profiling of extracellular vesicles from menstrual effluent for discovery of non-invasive diagnostic biomarkers of endometriosis | Sanjay Agarwal, MD |
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Pilot study of the IL-1 antagonist anakinra for the treatment of endometriosis related symptoms | 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 | |
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 | ||
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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | H. Irene Su, MD, MSCE |
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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 | ||
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 |
Division of Urogynecology and Reconstructive Pelvic Surgery
Study Title | Description | Eligibility | Contact | Location |
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The Impact of Placental Extracellular Vesicles in Gestational Diabetes on Regeneration of Female Pelvic Skeletal Muscle After Birth Injury | Lindsey Burnett, MD, PhD |
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Clinical accuracy of the UDI and MESA questionnaries in defining type of urinary incontinence in a multi-lingual population: a retrospective cohort study. | Lindsey Burnett, MD, PhD |
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Utilization of Reddit to Understand the Experiences of Patients with Vulvodynia, Vestibulodynia, and Vaginismus | Lindsey Burnett, MD, PhD |
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The Association of Self-Reported Recurrent Urinary Tract Symptoms and Hormonally Mediated Vestibulodynia | Lindsey Burnett, MD, PhD |
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Assessment of Fundamental Knowledge and comfortability of medical trainees in the Diagnosis and Treatment of Genitopelvic Pain Penetration Disorder (GPPPD) | Lindsey Burnett, MD, PhD |
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Sexual Function Outcomes After Gender Affirming Care Surgery Survey | Lindsey Burnett, MD, PhD |
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Intravesical Gentamicin in Adult Women with Recurrent Urinary Tract Infection: the Urinary Microbiome and Metabolmic Profile | Lindsey Burnett, MD, PhD |
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Shape modeling of bladder behavior using video urodynamic imaging - a pilot study | Lindsey Burnett, MD, PhD |
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Beta-Agonist versus Botox A® Trial for Urgency Urinary Incontinence (BEST) |
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. |
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Emily Lukacz, MD, MAS |
Division of Obstetrics and Gynecology (Generalist)
Study Title | Description | Eligibility | Contact | Location |
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Division of Hospitalist
Study Title | Description | Eligibility | Contact | Location |
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