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 »

  • 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

  • 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

  • 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: Monica Anderson, RN, BSN
    314-747-1390 | andersonmr@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

  • 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

    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

  • Endometrial intervention to improve IVF success rates

    Emily Jungheim, MD

    The objective of this study is to find out if endometrial mechanical stimulation (i.e. endometrial biopsy) prior to embryo transfer increases clinical pregnancy and live birth rates. Previous studies have shown that mechanical endometrial stimulation prior to embryo transfer may have a positive effect on clinical pregnancy and live birth rates.
    Goal: 100 participants

    Inclusion criteria:

    • Women 18-40 years old
    • Normoovulatory women with regular menstrual cycles defined as a cycle duration of 21-35 days will be enrolled
    • Regular cycles

    Exclusion criteria:

    • Known endometriosis

    Contact: Kristina Cipolla, Research Coordinator
    314-286-2458 | cipollak@wudosis.wustl.edu

  • EPIC (Effectiveness of Prolonged Use of IUD/Implanon)

    Colleen McNicholas, MD

    The progesterone-containing intrauterine device (Mirena® or LNG-IUD) is FDA-approved for 5 years of use and the subdermal contraceptive implant (Implanon® or ENG implant) is approved for 3 years. However, there is data in the literature that these methods may be highly effective for longer durations. This prospective cohort study will evaluate 675 LNG-IUD users and 675 ENG implant users who are within 6 months of expiration or beyond the end of the FDA-approved duration.

    Contact: Lisa Muench
    314-362-4317 | lisajmuench@wustl.edu

  • EPIC Assessing Ovarian Function During Prolonged Implant Use

    Colleen McNicholas, DO

    The purpose of this research study is to evaluate how the ovaries may be functioning while using the the Implanon®/Nexplanon® during the three years beyond the FDA approved duration. We will measure the activity of the ovary by checking progesterone levels (naturally occurring hormone found in the body) in blood. We will also check the etonogestrel levels (the hormone found in the implant). Lastly, data about bleeding patterns will be collected for 30 days.

    Contact: Lisa Muench
    314-362-4317 | lisajmuench@wustl.edu

  • EPIC Removal (Effectiveness of Prolonged Use of IUD/Implant for Contraception Removal Study)

    Colleen McNicholas, MD

    UPDATE: This study is currently in progress. We are no longer recruiting for this study.
    This prospective cohort study will evaluate 250 women who have used their implant (Implanon®/Nexplanon®) for a full 3 years or more or hormonal IUD (Mirena®) for the full 5 years or more, are having their implant or IUD removed but still do not want a pregnancy for at least 12 months. The EPIC Removal study will track future contraceptive method use, patient satisfaction and unintended pregnancies. We will compare pregnancy rates of implant/IUD users enrolled in the EPIC Prolonged Use study with women enrolled in the EPIC Removal study using a variety of methods or no method after removal of their IUD or implant.

    Contact: Lisa Muench
    314-362-4317 | lisajmuench@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: Monica Anderson, RN, BSN
    314-747-1390 | andersonmr@wustl.edu

  • GEMINI (Genetics of Male Infertility Initiative)

    Kenan Omurtag, MD

    An NIH study established to identify the genetic causes of male infertility. One blood draw.
    Goal: 200 participants

    Inclusion criteria:

    • Men 18-55 years old
    • Men with extremely low sperm concentration (<5 million sperm/mL) on semen analysis

    Exclusion criteria:

    • Obstruction or absence of vas deferens
    • Varicocele
    • History of cryptorchidism
    • Radical pelvic surgery
    • Anejaculation
    • Spinal cord injury
    • Radiation treatments
    • Y chromosome microdeletions (YCMD) or karyotypic abnormalities

    Contact: Kristina Cipolla, Research Coordinator
    314-286-2458 | cipollak@wudosis.wustl.edu

  • LIFE (Levonorgestrel Intrauterine System for Emergency Contraception)

    Colleen McNicholas, DO

    This study will evaluate the effectiveness of the Levonorgestrel intrauterine system (LNG-IUS) as a method of emergency contraception by comparing observed pregnancy rates in those receiving oral levonorgestrel, ulipristal acetate (Ella) or LNG-IUS.

    Contact: Loire Biggs
    314-747-1425 | loirebiggs@wustl.edu

  • Lifestyle and Ovarian Aging (LORE)

    Emily Jungheim, MD

    LORE is a research project working to determine the link between lifestyle factors and fertility. Participants are eligible for a $30 Target gift card. Must complete 3 surveys, a blood draw, and transvaginal ultrasound.

    Inclusion criteria:

    • Women ages 18-44
    • History of regular menstrual cycles
    • Not taking birth control pills

    Exclusion criteria:

    • Currently pregnant
    • History of ovarian surgery, infertility
    • Major chronic disease

    Contact: Kristina Cipolla, Research Coordinator
    314-286-2458 | cipollak@wudosis.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: Monica Anderson, RN, BSN
    314-747-1390 | andersonmr@wustl.edu

  • MK-3475 Immunotherapy in Endometrial Carcinoma

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

    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

  • 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

    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: Monica Anderson, RN, BSN
    314-747-1390 | andersonmr@wustl.edu

  • Oxygen for Category II Intrauterine Fetal Resuscitation: A randomized, noninferiority trial

    PI: Raghuraman, Nandini, MD

    The objective of this study is to investigate the utility of maternal oxygen administration in patients with Category II FHT and to compare the effectiveness of this option to room air. Our hypothesis is that room air along, is not inferior to the current practice of maternal oxygen administration for category II FHT.

    Contact: Monica Anderson, RN, BSN
    314-747-1390 | andersonmr@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

    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

  • PPHTN: Furosemide for Prevention of Severe Postpartum Hypertension

    PI: Methodius Tuuli, MD

    A randomized controlled trial to test the efficacy and safety of postpartum furosemide for preventing severe postpartum hypertension in women with Gestational Hypertension or PreEclampsia. Our central hypothesis is that prophylactic postpartum furosemide, by promoting excretion of excess fluid and sodium, will reduce severe postpartum hypertension in high-risk women.

    Contact: Monica Anderson, RN, BSN
    314-747-1390 | andersonmr@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: Monica Anderson, RN, BSN
    314-747-1390 | andersonmr@wustl.edu

  • Radiation Therapy, Gemcitabine Hydrochloride, and Cisplatin in Treating Patients With Locally Advanced Squamous Cell Carcinoma of the Vulva

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

    This phase II trial studies how well giving radiation therapy together with gemcitabine hydrochloride and cisplatin work in treating patients with locally advanced squamous cell carcinoma of the vulva. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with gemcitabine hydrochloride and cisplatin may kill more tumor cells.

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

    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

  • Reproductive Endocrinology / Fertility

    The Fertility and Reproductive Medicine Center participates in a number of individual and multi-center clinical studies. These studies use new interventions to diagnose and treat any number of conditions related to reproductive endocrinology and infertility, such as ovulation disorders, recurrent miscarriage and male factor infertility.

    Contact: Kristina Cipolla, Research Coordinator
    314-286-2458 | cipollak@wudosis.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

     

  • The ACTorNOT Trial: Optimal treatment for women with a Persisting Pregnancy of Unknown Location (PPUL)

    Emily Jungheim, MD

    A randomized clinical trial of women at risk for an ectopic pregnancy: Active Treatment versus Expectant Management (no treatment). This is for stable women with a confirmed PPUL to be randomized to one of three strategies:

    1. Uterine evacuation followed by methotrexate (MTX) for some (those that have evidence of a non-visualized ectopic pregnancy)
    2. Empiric treatment with MTX for all
    3. Expectant management

    **Recruiting from our clinical population only

    Contact: Kristina Cipolla, Research Coordinator
    314-286-2458 | cipollak@wudosis.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: Lorene Temming, MD

    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: Monica Anderson, RN, BSN
    314-747-1390 | andersonmr@wustl.edu

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

    PI: Ann Gronowski, PhD; Kelle Moley, MD

    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: Monica Anderson, RN, BSN
    314-747-1390 | andersonmr@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