Clinical Trials

Many of our physicians are also leading researchers in their specialties, making breakthroughs and contributing to discoveries that are shaping their fields. Their research may offer some of our patients the additional benefit of having access to treatments that are under review in clinical trials.

Enrolling in a study does not always include testing a new treatment. Participating in a study can be as simple as answering a phone survey every few months to help doctors better understand healthy development, the effectiveness of prevention behaviors or the progression of a disease state. You will never be enrolled in a clinical study without your consent, and our physicians will give you complete information about a study that interests you before you choose whether to take part.

Learn more on the Washington University Physicians website:
Read the frequently asked questions about clinical trials »

Get notifications from Volunteer for Health:
Register to hear when you may have matched to a study »

Find a study in the National Institutes of Health (NIH) registry:
Search studies in all specialties at Washington University »


Find a clinical trial in obstetrics and gynecology

To request more information about a study below, you may email dcr@wustl.edu.

  • Preterm birth

    PI: George Macones, MD • Sponsored by March of Dimes

    The Washington University March of Dimes Prematurity Research Center is recruiting 1,000 volunteers for a study that follows women throughout pregnancy. The purpose is to learn more about how the body changes during pregnancy and why some babies are born too early. Ultimately, we hope our research will help to lower the rate of preterm birth, which is higher in St. Louis (12.5% of live births) and St. Louis County (10.6%) than the national average (9.6%), especially among black women.

    Visit the Prematurity Research Center website to learn more »

  • 17OHP Dosing: Impact of a higher dose on the pharmacokinetics of 17-alpha hyroxyprogesterone caproate in obese women

    PI: Molly Stout, MD, MSCI

    The purpose of this research study is to determine if a higher weekly dose of 500mg of 17OHP in obese women results in a higher amount of the medication found in the blood compared to the standard dose of 250mg.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • A Randomized Phase II Study of Chemoradiation and Pembrolizumab for Locally Advanced Cervical Cancer

    PI: Julie Schwarz, MD • Sponsors: Linda Duska & Merck Sharp & Dohme Corp.

    The purpose of this study is to evaluate the safety and effectiveness of immunotherapy in combination with chemotherapy and radiation (chemoradiation) for the treatment of advanced cervical cancer. Pembrolizumab, a type of immunotherapy called a checkpoint inhibitor, will be administered after or during chemoradiation.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • Aravive AVB500-OC-002: A phase 1b/2 randomized, controlled study of avb-s6-500 in combination with pegylated liposomal doxorubicin or paclitaxel in patients with platinum-resistant recurrent ovarian cancer

    PI: Premal Thaker, MD, MS • Sponsor: Aravive Biologics

    This is a Phase 1b/2 study of AVB-S6-500 in combination with pegylated liposomal doxorubicin (PLD) or paclitaxel (Pac) in patients with platinum resistant recurrent ovarian cancer. The phase 1b portion of the study is open label and patients will receive either AVB-S6-500+PLD or AVB-S6-500+ Pac. The Phase 2 portion of the study is randomized, double-blind, placebo-controlled study to compare efficacy and tolerability of AVB-S6-500 in combination with PLD or Pac versus placebo plus PLD or Pac.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

     

  • Behavioral Influences on Ovarian Cancer Progression: Role of Chemoresistance

    PI: Permal Thaker, MD • Sponsor: NIH

    The purpose of this study is to understand the relationships between psychological and social factors, the expression of chemoresistance related genes in tumor tissue, and the clinical outcomes in ovarian cancer patients. The significance of this research is that it may help in our understanding of risk factors for progression of ovarian cancer.

    Contact: Elena Jones
    314-747-0918 | jonesmariaelena@wustl.edu

  • Celsion Ovation II: A Phase I/II study Evaluating the Dosing, Safety, Efficacy, and Biological Activity of Intraperitoneal GEN-1 (IL-12 Plasmid Formulated with PEG-PEI-Cholesterol Lipopolymer) Administered in Combination with Neoadjuvant Chemotherapy (NACT) in Patients Newly Diagnosed with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

    PI: Lindsay Kuroki, MD • Sponsor: Celsion

    This is a randomized, open label, multicenter trial to evaluate the safety, dosing, efficacy and biological activity of intraperitoneal GEN-1 plus NACT compared to NACT alone.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • CHAP: Antihypertensive Therapy for Mild Chronic Hypertension during Pregnancy

    PI: Methodius Tuuli, MD • Sponsored by a NIH grant

    Antihypertensive therapy to a standardized BP goal <140/90, compared with ACOG recommendations (no treatment), for mild CHTN reduces the frequency of key adverse maternal and newborn outcomes associated with CHTN including 1) a composite perinatal outcome (perinatal death, placental abruption, severe preeclampsia or indicated PTB <35 weeks) and 2) SGA (birth weight <10th percentile).  The purpose of this study is to evaluate whether a BP treatment strategy to achieve targets that are beneficial for non-pregnant adults (<140/90 mmHg) is safe and effective during pregnancy. This is a multi-center randomized trial.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • CUTI (Cancer of the Uterus and Treatment of Stress Urinary Incontinence)

    Carolyn McCourt, MD • Jerry Lowder, MD

    UPDATE: This study is currently in progress. We are no longer recruiting for this study.
    The purpose of this study is to compare quality of life in women with endometrial cancer or atypical hyperplasia and Stress Urinary Incontinence (SUI) who undergo SUI and endometrial cancer surgery simultaneously to women that do not. In addition, this study will determine if there are differences in the clinical outcomes of women with SUI who have concurrent surgery compared to those that do not. Overall we expect women that choose concurrent SUI and cancer surgery will have improved quality of life (QoL) scores, but no difference in clinical outcomes.

    Contact: Zoe Jennings
    jenningsz@wudosis.wustl.edu

  • Cytokine-Induced Depression in Ovarian Cancer: Activation of Kynurenine Pathway (KL2)

    PI: Lindsay Kuroki, MD • Sponsor: Institutional Grant Award

    The overall scientific goal of this proposal is to define the role of IDO1 driven cytokine-induced depression in patients with ovarian tumors. We hypothesize that IDO1 driven cytokine-induced depression is present in a subset of ovarian cancer patients at diagnosis and impacts their cancer journey from diagnosis to 1-year follow-up outcomes.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • Diet and Physical Activity Change or Usual Care in Improving Progression-Free Survival in Patients With Previously Treated Stage II, III, or IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    PI: David Mutch, MD • NCI Cooperative Group

    UPDATE: This study is currently in progress. We are no longer recruiting for this study.

    This randomized phase III trial studies whether changes in diet and physical activity can increase the length of survival without the return of cancer (progression-free survival) compared with usual care in patients with previously treated stage II, III, or IV ovarian, fallopian tube, or primary peritoneal cancer. A healthy diet and physical activity program and counseling may help patients make healthier lifestyle choices. It is not yet known whether changes in diet and exercise may help increase progression-free survival in patients with previously treated cancer.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • GDM group: Group versus Traditional Prenatal Care for Diabetes: A Randomized Controlled Trial

    PI: Ebony Carter, MD • Sponsored by CDTR funding

    A randomized trial to test group prenatal care on self-care activities, compared to traditional prenatal care, will improve glycemic control and, ultimately, maternal and neonatal outcomes in women with type 2 and gestational diabetes.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • GOG 3015: A Phase III, Multicenter, Randomized, Study of Atezolizumab Versus Placebo Administered in Combination With Paclitaxel, Carboplatin, and Bevacizumab to Patients With Newly-Diagnosed Stage III or Stage IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    PI: Premal Thaker, MD, MS • Sponsor: GOG Foundation and Hoffmann-LaRoche

    Update: This study is not currently recruiting

    This is a Phase III, global, double-blind, 2-arm randomized study designed to compare the efficacy and safety of atezolizumab + paclitaxel + carboplatin + bevacizumab versus placebo + paclitaxel + carboplatin + bevacizumab. Study participants will have Stage 3 or 4 ovarian cancer (OC), fallopian tube cancer (FTC), or primary peritoneal cancer (PPC) with macroscopic residual disease postoperatively (i.e., after primary tumor reductive surgery) or who will undergo neoadjuvant therapy followed by interval surgery.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • GOG 3020: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study in Ovarian Cancer Patients Evaluating Rucaparib and Nivolumab as Maintenance Treatment Following Response to Front-Line Platinum-Based Chemotherapy

    PI: Premal Thaker, MD, MS • Sponsor: GOG Foundation and Clovis Oncology

    This is a Phase 3, randomized, multinational, double-blind, dual placebo-controlled, 4-arm study evaluating rucaparib and nivolumab as maintenance treatment following response to front-line treatment in newly diagnosed ovarian cancer patients. Response to treatment will be analyzed based on homologous recombination (HR) status of tumor samples.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • L105: A Phase 3, Multicenter, Open-Label Study of a Levonorgestrel 52 mg Intrauterine System for the Treatment of Heavy Menstrual Bleeding

    PI: David Eisenberg, MD

    The purpose of this study is to evaluate if Liletta IUD (a hormonal intrauterine device) is a safe and effective treatment for women with very heavy menstrual bleeding. Participants must be female, 18-50 years old, and must report heavy periods when not using hormonal contraception or a copper IUD. They will be asked to come to the clinic for up to 8 study visits.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • MAXI-K: The role and regulation of maxi-k channel during pregnancy

    PI: Sarah England, PhD • Sponsored by an NIH grant

    This is a prospective study looking at the control of muscle contractions of the uterus during labor by looking at channel proteins in the uterine muscle. These channel proteins are involved in muscle functions. Approximately 1000 women will be recruited from Barnes Jewish Hospital who are undergoing cesarean delivery or hysterectomy.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • Merck Keynote 826: A Phase 3 Randomized, Double-Blind, Placebo-Controlled Trial of Protocol # 826-00 Pembrolizumab (MK-3475) Plus Chemotherapy Versus Chemotherapy Plus Placebo for the First-Line Treatment of Persistent, Recurrent, or Metastatic Cervical Cancer

    PI: Premal Thaker, MD, MS • Sponsor: Merck

    The purpose of this study is to assess the efficacy and safety of pembrolizumab (MK-3475) plus one of four platinum-based chemotherapy regimens compared to the efficacy and safety of placebo plus one of four platinum-based chemotherapy regimens in the treatment of adult women with persistent, recurrent, or metastatic cervical cancer. Possible chemotherapy regimens include: paclitaxel plus cisplatin with or without bevacizumab and paclitaxel plus carboplatin with or without bevacizumab.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • MK-3475 Immunotherapy in Endometrial Carcinoma

    PI: Dr. Premal Thaker, MD • Sponsors: Washington Unversity School of Medicine & MERCK

    UPDATE: This study is currently in progress. We are no longer recruiting for this study.

    The purpose of this research study is to learn more about how endometrial cancer responds to treatment with a drug called MK-3475 (also known as pembrolizumab).

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • Neoadjuvant Chemotherapy Tumor Profiling in Ovarian Cancer: Genomic and Proteomic Analysis (U10)

    PI: Katherine Fuh, MD, PhD • Sponsor: NCI

    To identify targetable elements by performing real-time evaluation of genomic or proteomic changes in ovarian cancer during neoadjuvant chemotherapy treatment.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • NRG GY005 – A Randomized Phase II/III study of the combination of Cediranib and Olaparib compared to Cediranib or Olaparib alone, or Standard of care chemotherapy in women with recurrent platinum-resistant or -refractory ovarian, fallopian tube, or primary peritoneal cancer (COCOS)

    PI: David Mutch, MD • Sponsor: NCI Cooperative Group

    Update: This trial is currently in Phase 3

    This randomized phase II/III trial studies how well cediranib maleate and olaparib work when given together or separately, and compares them to standard chemotherapy in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has returned (recurrent) after receiving chemotherapy with drugs that contain platinum (platinum-resistant) or continued to grow while being treated with platinum-based chemotherapy drugs (platinum-refractory). Cediranib maleate and olaparib may stop the growth of tumor cells by blocking enzymes needed for cell growth. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether giving cediranib maleate and olaparib together may cause more damage to cancer cells when compared to either drug alone or standard chemotherapy.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • NRG GY007: A Phase I/II Study of Ruxolitinib with Front-Line Neoadjuvant and Post-Surgical Therapy in Patients with Advanced Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Cancer

    PI: Premal Thaker, MD • Sponsor: NCI Cooperative Group

    This phase I/II partially randomized trial studies the side effects and the best dose of ruxolitinib phosphate when given together with paclitaxel and carboplatin and to see how well they work in treating patients with stage III-IV epithelial ovarian, fallopian tube, or primary peritoneal cancer. Ruxolitinib phosphate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving ruxolitinib phosphate together with paclitaxel and carboplatin may be a better treatment for epithelial ovarian, fallopian tube, or primary peritoneal cancer.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • NRG GY009:  A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP-Supplied Atezolizumab (IND #134427) versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP-Supplied Atezolizumab versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer.

    PI: Premal Thaker, MD, MS • Sponsor: NCI Cooperative Group

    Update: This trial is currently suspended to enrollment

    This randomized phase II/III trial studies how well pegylated liposomal doxorubicin hydrochloride with atezolizumab and/or bevacizumab work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back. Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Immunotherapy with monoclonal antibodies, such as atezolizumab and bevacizumab, may help the body’s immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. It is not yet known which combination will work better in treating patients with ovarian, fallopian tube, or primary peritoneal cancer.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • NRG GY012: 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

    PI: David Mutch, MD • Sponsor: NCI Cooperative Group

    Update: We are not currently recruiting for this study

    To compare the efficacy of single-agent olaparib and the combination of olaparib and cediranib (and potentially other combination arms that may be added by subsequent amendment) versus single agent cediranib as measured by progression free survival (PFS), in patients with recurrent, persistent or metastatic endometrial cancer.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • NRG GY014: A Phase II Study of Tazemetostat (EPZ-6438) (IND # 138671) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma

    PI: Premal Thaker, MD, MS • Sponsor: NCI Cooperative Group

    This phase II trial studies how well tazemetostat works in treating patients with ovarian, primary peritoneal, or endometrial cancer that has come back. Drugs used in chemotherapy, such as tazemetostat, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • Nutraceutical efficacy for recurrent UTIs

    Stacy Lenger, MD

    This is a study designed to evaluate the effectiveness of a dietary supplement (known as a nutraceutical) as a non-antibiotic treatment to prevent repeated urinary tract infections in women that have completed menopause and are on vaginal estrogen therapy.  A separate arm of the study will also evaluate the effectiveness of a dietary supplement in patients who do not use vaginal estrogen therapy. In the past, patients with repeated UTIs have been placed on long-term antibiotics to try to prevent them from happening again. With more concern about antibiotics not working and side effects from antibiotics, some healthcare providers prefer other treatment options. This study investigates a combination treatment approach to preventing recurrent UTIs.

    You may be a candidate if: you have completed menopause and have two positive urine tests in the last 6 months or three positive urine tests in the last 12 months.

    Contact: Stacy Lenger, MD
    314-747-1402 | slenger@wustl.edu

  • Olaparib or Cediranib Maleate and Olaparib Compared With Standard Platinum-Based Chemotherapy in Treating Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

    PI: David Mutch, MD • Sponsor: NCI Cooperative Group

    UPDATE: This study is currently in progress. We are no longer recruiting for this study.

    This randomized phase III trial studies olaparib or cediranib maleate and olaparib to see how well they work compared with standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer that has come back. Olaparib and cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Cediranib maleate may stop the growth of ovarian, fallopian tube, or primary peritoneal cancer by blocking the growth of new blood vessels necessary for tumor growth. Drugs used in chemotherapy, such as carboplatin, paclitaxel, gemcitabine hydrochloride, and pegylated liposomal doxorubicin hydrochloride work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether olaparib or cediranib maleate and olaparib is more effective than standard platinum-based chemotherapy in treating patients with platinum-sensitive ovarian, fallopian tube, or primary peritoneal cancer.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • OMSS: Optimizing Management of the Second Stage of Labor

    PI: Alison Cahill, MD & Methodius Tuuli, MD • Sponsored by a NIH grant

    This is a multi-center randomized trial of nulliparous women to compare the effectiveness of immediate and delayed pushing in the second stage of labor. We aim to test the central hypothesis that immediate pushing in the second stage of labor increases spontaneous vaginal delivery, shortens duration of the second stage, and reduces adverse neonatal and maternal outcomes. Secondary aim is to determine the effect of immediate pushing on the rate of neonatal composite morbidity and determine the impact of immediate versus delayed pushing on objective and subjective measures of maternal pelvic floor morbidity.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • OnTarget: A Phase 3, Randomized, Single Dose, Open-Label Study to Investigate the Safety and Efficacy of OTL38 Injection (OTL38) for Intra-operative Imaging of Folate Receptor Positive Ovarian Cancer

    PI: Premal Thaker, MD, MS • Sponsor: OnTarget Laboratories

    This is a phase 3, randomized, multi-center, single dose, open label, pivotal study in patients diagnosed with, or with high clinical suspicion of, ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery. The Phase 3 study is to confirm the efficacy of OTL38 in combination with fluorescent light to detect additional Folate Receptor-positive (FR+) ovarian cancer lesions not detected by palpation and visualization under normal light in patients with FR+ ovarian cancer scheduled to undergo primary surgical cytoreduction, interval debulking, or recurrent ovarian cancer surgery.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

     

  • OXYGEN Trial: Intrapartum maternal oxygen supplementation: Effects on the mother and neonate

    PI: Nandini Raghuraman, MD, MS

    The purpose of this research study is to see if giving mothers oxygen or room air for certain patterns in the baby’s heart monitoring can change the heart monitoring, neonatal outcomes, or affect the baby’s routine cord blood results. We are also studying if oxygen and room air affect the amount of stress we see in a mom and baby’s cells and tissues. Participants are randomized to receive either room air or oxygen supplementation.  A subset of randomized participants will undergo a neonatal MRI.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • Paclitaxel and Carboplatin or Bleomycin Sulfate, Etoposide Phosphate, and Cisplatin in Treating Patients With Advanced or Recurrent Sex Cord-Ovarian Stromal Tumors

    PI: David Mutch, MD • Sponsor: NCI Cooperative Group

    This randomized phase II trial studies paclitaxel and carboplatin to see how well they work compared with bleomycin sulfate, etoposide phosphate, and cisplatin in treating patients with sex cord-ovarian stromal tumors that have spread to other places in the body and usually cannot be cured or controlled with treatment (advanced) or has returned (recurrent). Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving more than one drug (combination chemotherapy) may kill more tumor cells. It is not yet known which chemotherapy regimen is more effective in treating sex cord-ovarian stromal tumors.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • Paclitaxel and Carboplatin With or Without Metformin Hydrochloride in Treating Patients With Stage III, IV, or Recurrent Endometrial Cancer

    PI: David Mutch, MD • Sponsor: NCI Cooperative Group

    UPDATE: This study is currently in progress. We are no longer recruiting for this study.

    This randomized phase II/III trial studies how well paclitaxel, carboplatin, and metformin hydrochloride works and compares it to paclitaxel, carboplatin, and placebo in treating patients with endometrial cancer that is stage III, IV, or has come back. Drugs used in chemotherapy, such as paclitaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Metformin hydrochloride may help paclitaxel and carboplatin work better by making cancer cells more sensitive to the drugs. It is not yet known whether paclitaxel and carboplatin is more effective with or without metformin hydrochloride in treating endometrial cancer.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • PANDA Trial: Preeclampsia and Nonsteroidal Drugs for Analgesia: a randomized non-inferiority trial

    PI: Jonathan Hirschberg, MD

    The purpose of this research study is to determine if the use of non-steroidal anti-inflammatories (NSAIDs), such as ibuprofen, worsen hypertensive diseases of pregnancy when given post-delivery. Participants are randomized at delivery to Standard Analgesia or NSAID-free analgesia pain management postpartum.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • PII: Applying Diffusion Basis Spectrum Imaging to Characterize Human Placenta Immuno-response during normal term and preterm pregnancies

    PI: Nandini Raghuraman, MD, MS • PI: Yong Wang, PhD

    The purpose of this research study it to develop a safe, noninvasive technology capable of assessing placental health early in pregnancy. We aim to develop Placental Immune Imaging (PII), a system based on a nonconventional magnetic resonance imaging (MRI) technique. By doing this study, we hope to learn more about healthy, term pregnancies and identify characteristics of pregnancies at risk for preterm birth.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • PREVENA: Prophylactic Negative Pressure Wound Therapy in Obese Women after Cesarean

    PI: Methodius Tuuli, MD • Sponsored by a NIH grant

    A randomized trial to determine the effectiveness of prophylactic Negative Pressure Wound Therapy (NPWT) in reducing the rate of surgical site infections (SSIs) after cesarean in obese women.  Assess the safety of prophylactic NPWT in obese women as measured by frequency of adverse events including skin blisters, erythema, wound bleeding, and prolonged wound drainage.  Determine the effect of prophylactic NPWT on the frequency and identity of bacteria, including antibiotic-resistant organisms, isolated from SSIs after cesarean in obese women.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • Randomized Trial of Nivolumab with or without Ipilimumab in Patients with Persistent or Recurrent Epithelial Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

    PI: David Mutch, MD • Sponsor: NCI Cooperative Group

    UPDATE: This study is currently in progress. We are no longer recruiting for this study.

    This randomized phase II trial studies how well nivolumab works with or without ipilimumab in treating patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer that has not responded after prior treatment (persistent) or has come back (recurrent). Monoclonal antibodies, such as nivolumab and ipilimumab, may block tumor growth in different ways by targeting certain cells.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • Roche/YO40482: A Phase IB Study of Cobimetinib Administered in Combination With Niraparib, With or Without Atezolizumab, to Patients With Advanced Platinum-Sensitive Ovarian Cancer

    PI: David Mutch, MD • Sponsor: Hoffmann-LaRoche

    The study will include a safety run-in phase (Stage 1) and a randomization phase (Stage 2).

    The purpose of Stage 1 is to evaluate the safety of cobimetinib when administered in combination with niraparib (Cohort 1) and cobimetinib with niraparib plus atezolizumab (Cohort 2).

    Stage 1 will enable patient enrollment in the randomized phase of the study (Stage 2) with both regimens at the recommended dose levels from Stage 1.

    Stage 2 is a randomized, dose-expansion phase, evaluating clinical outcomes in patients with advanced platinum-sensitive ovarian cancer.

    All patients will continue to receive study treatment until disease progression (according to “Response Evaluation Criteria in Solid Tumors” (RECIST), Version 1.1, unacceptable toxicity, death, or patient or investigator decision to withdraw, whichever occurs first.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • Study for treatment of patients with hip and pelvic floor pain

    Melanie Meister, MD

    The purpose of this study is to better understand the type of patients who are diagnosed with hip and pelvic floor pain. Pelvic floor pain is pain coming from the muscles and connective tissue of the pelvis. This pain can be brought on by trigger points, tender points, and local pain. Even though this pain is common in adult women, not a lot of doctors check patients for these points, even when they complain of pelvic pain.  In this study, we are very interested in other symptoms that often happen with this hip and pelvic floor pain. Some examples are a sudden need to go to the bathroom, going to the bathroom more than normal, pain with urination, and not being able to hold it until you get to a bathroom. and symptoms of pelvic organ prolapse (heaviness, pressure). We are also interested in investigating the change in these symptoms after a course of treatment.

    You may be a candidate if: you have bothersome urinary or bladder symptoms and are found to have hip and pelvic floor pain on examination.

    Contact: Melanie Meister, MD
    314-273-1329 | meisterm@wustl.edu

     

  • Targeted lifestyle change (TLC) group prenatal care for obese women at high risk for gestational diabetes: A randomized controlled trial.

    PI: Ebony Carter, MD, MPH

    This study is a randomized controlled trial testing the intervention Targeted Lifestyle Change Prenatal Group Care (TLC).  The purpose of this study is to determine the effects of TLC on maternal and neonatal outcomes.  We enroll and randomize women, early in pregnancy, who are at high risk of developing gestational diabetes to receive either traditional prenatal care or TLC and follow them throughout pregnancy and postpartum.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • UPFRONT: Multi-component implementation of shared decision making (SDM) for uterine fibroids across socioeconomic strata

    PI: Tessa Madden, MD

    Uterine fibroids are prevalent among adult women, with nearly half of reproductive-age women experiencing them.  There are many options available to treat uterine fibroids, each with their own tradeoffs.  Because of this, patient preference plays a large role in the treatment decision.  We plan to use a tool called an Option Grid, which is designed to facilitate conversation between patients and providers about treatment options that are aligned with patient preferences.  We hope to gain an understanding of how an Option Grid can be implemented and sustained in diverse clinical settings.

    We will enroll two groups of participants: patients seeking treatment with our physicians for new or recurrent symptoms of uterine fibroids (e.g. heavy menstrual bleeding, pelvic pressure or pain, etc.) and physicians who provide care to these patients.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • Use of vaginal estrogen cream to treat bladder infections in women who have gone through menopause

    Jerry Lowder, MD

    Urinary tract infections (UTIs) and irritative voiding symptoms (urinary urgency, frequency) are common in women of all ages but occur more frequently in women who have gone through menopause. Vaginal estrogen cream therapy is used to treat lower urinary tract symptoms and to prevent urinary tract infections. However, the current strength and dosing recommendations are not standardized or evidence-based, and how vaginal estrogen works is not very clear. Even though this treatment is considered first-line therapy in gynecology, many physicians and patients may not “believe” that a topical vaginal estrogen therapy really works.

    This study will look at UTIs and many irritative voiding symptoms that have an inflammatory response and will examine the effect of the form of cream (Estrace™ non-liquefying cream, USP, 0.01%) the doctor prescribes to women with urinary tract infections who have gone through menopause.

    You may be a candidate if: you have recurrent bladder infections

    Contact: Melanie Meister, MD
    314-273-1329 | meisterm@wustl.edu

  • Vaginal Prep: Vaginal Cleansing Before Cesarean Delivery to Reduce Infection: A Randomized Trial

    PI: Nandini Raghuraman, MD, MS

    A randomized trial to compare the standard-of-care preoperative abdominal cleansing to abdominal cleansing plus vaginal cleansing with povidone-iodine solution prior to cesarean delivery of women in labor.  To attempt to provide this Level 1 evidence by performing a clinical trial to test the central hypothesis that vaginal cleansing with povidone-iodine solution immediately prior to cesarean delivery reduces postcesarean infectious morbidity.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • Vulvar ABX: Does antibiotic prophylaxis reduce wound complications after vulvar excision of premalignant lesions: A Double-Blinded Randomized Controlled Trial

    PI: Maggie Mullen, MD • Sponsor: Institutional Grant Award

    A randomized control trial will provide the most reliable data to determine the role of prophylactic antibiotics to decrease the wound complication rate. The investigators plan to perform a pilot study to evaluate actual rates of wound complications and how long it takes to recruit 50 patients.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • Women Choosing Surgical Prevention

    PI: Andrea Hagemann, MD • Sponsor: Department funded

    This phase II trial studies how well surgery works in preventing ovarian cancer in patients with genetic mutations at risk of ovarian cancer. Risk reducing salpingo oophorectomy (RRSO) is surgery to remove the fallopian tubes and ovaries at the same time. Interval salpingectomy with delayed oophorectomy (ISDO) is surgery to remove the fallopian tubes. It is not known whether ISDO works better than RRSO at lowering risk of ovarian cancer and improving the sexual function and psychosocial well-being in patients with genetic mutation.

    Contact: Stephanie Russell, MPH
    314-362-1705 | swrussell@wustl.edu

  • Women’s and infant’s health specimen collection and processing

    PI: Emily Jungheim, MD, MSCI

    The study aim is to create a structure to facilitate the collection of patient specimens for women and infant’s health research. The Women and Infants Health Specimen Consortium provides specimen collection, specimen storage and processing, as well as the maintenance of a comprehensive database of outcomes data.

    Contact: Tracy Burger, RN, BSN
    314-747-1390 | tburger@wustl.edu

  • Women’s Genitourinary Tract Specimen Consortium

    Indira Mysorekar, PhD • Jerry L. Lowder, MD, MSc • Christine M. Chu, MD • Melanie Meister, MD • Stacy Lenger, MD

    The purpose of the study is to facilitate the creation of a specimen bank (biobank) of genitourinary tract samples. These specimens will be collected from non-pregnant women of different age groups and will be available to many researchers.  Samples collected may include blood, urine, vaginal swabs, bladder biopsies or endometrial samples. For more information, visit the Center for Reproductive Health Sciences.

    Contact: Indira Mysorekar, PhD
    314-747-1329 | imysorekar@wustl.edu