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URMC / Obstetrics & Gynecology / Research / Current Clinical Studies

 

Current Clinical Studies

The faculty of Obstetrics and Gynecology regularly conduct clinical research on new devices and medications that may assist in the future health of women. Scroll down to see what we're studying and how you can participate.

Studies for Pregnant Women

Group B Strep Surveillance Study

Group B streptococcus is a leading cause of hospitalization and death among infants. This study is a partnership with the NYS Department of Health, CDC, and URMC to conduct a case control study to compare maternal antibody levels in cases of neonatal GBS infection and controls in order to help establish immunologic endpoints. We are asking all pregnant patients who screen GBS+ at URMC clinics if they would be willing to donate their GBS swab to the state. Patients will receive $15 to Target 4-12 weeks after delivery.

The DECIDE Study

Preexisting diabetes in the mother has to the potential to significantly increase the risk to the fetus, including congenital anomalies, excessive fetal growth, respiratory distress syndrome, and profound neonatal hypoglycemia. The risk of stillbirth is also increased in women with diabetes. The DECIDE study looks to assess ultra-sonographic and blood markers of fetal cardiac dysfunction are associated with adverse fetal outcome in women with poorly controlled preexisting diabetes as compared to normal pregnancies. Women are asked to undergo an extra ultrasound procedure in their 3rd trimester, and to donate cord blood and amniotic fluid at delivery. There is no compensation for this study.

Short Cervix Study

Patients identified as having a cervix less than 2 cm are considered high risk for pre term delivery. The purpose of this study is to determine if there are subclinical myometrial contractions occurring that can be identified by a specific electrical pattern in the uterine myometrium of women who have a short cervix at the mid-trimester (16 0/7 – 22 6/7 weeks) compared to women with a normal length cervix. Patients will be asked to allow stickers and electrodes to be placed on their belly, and be monitored for one hour prior to receiving any intervention for their short cervix. Patients will be identified through provider referral and ultrasound screening. Patients will be compensated $50 for their time.

STePP – Structural Properties of Placentae

The purpose of this study is to visualize the structural and vascular characteristics of healthy placentae, and compare them to placentae in women with ischemic placental disease (pre-eclampsia, IUGR, placental abruption). Patients will be asked if eligible upon admission to Labor and Delivery if they would be interested in participating. Participation requires donating the placenta after delivery, and access to the patient’s medical chart concerning their current pregnancy. Patients will be paid $20 for their time.

Registry of Complicated Monochorionic Twin Pregnancies

Patients who are pregnant with monochorionic (identical) twins will be asked if they would be willing to participate in a data registry of similar patients in order to better coordinate care for future patients with the same condition. No identifying information will be entered into the registry. There is no compensation for this study.

Testing a Volume Sweep Imaging (VSI) Ultrasound Protocol for Obstetrics

Ultrasound remains an inaccessible diagnostic technology for obstetric patients in low resource environments throughout the world. Volume sweep imaging uses large imaging sweeps to cover the target region or organ using only external body landmarks and requires minimal training to operate. Comparing results from standard of care ultrasounds to these portable imaging VSI devices is important to establish the effectiveness and demonstrate that novices can employ this technique in underserved regions. Patients who are pregnant and undergoing a routine obstetric ultrasound will be asked to participate by allowing the study team to scan their abdomen using this portable ultrasound device after completion of their routine ultrasound. There is no compensation for this study.

IDO and FGR

The kynurenine (kyn) pathway is mediated by indoleamine 2,3 dioxygenase 1 (IDO1) in the placenta, and results in generation of numerous metabolites, each of which have distinct immunosuppressive, vasoregulatory and neuromodulatory effects. Studies have linked decreased IDO1 expression to fetal growth restriction, pre eclampsia, and spontaneous miscarriage. Placentas from patients experiencing fetal growth restriction will be collected and examined for IDO expression. There is no compensation for this study.

Upcoming

  • RSV Vaccine Trial
  • AMAG-423

Studies of Polycystic Ovarian Syndrome

Abbvie

This is a Phase 2, multicenter, double-blind (sponsor-unblinded), randomized, placebo-controlled study to assess the safety and efficacy of Elagolix in women with polycystic ovary syndrome (PCOS). PCOS is one of the most common hormonal disorders in women of reproductive age, yet few treatment options are available. This study will help determine if Elagolix can impact disordered hormonal dynamics in women with PCOS and at what dosage. Patients receive compensation for time and travel, pro rated over the course of 26 weeks.

Cornell Study

This is a study looking at the need to improve the methods and criteria defining polycystic ovarian syndrome across populations. Both normal controls and patients with a PCOS diagnosis are needed. Following informed consent, a detailed medical history and PCOS symptom assessment, patients will be asked to come to clinic on the first through fifth day of their menstrual cycle to obtain a transvaginal ultrasound of their ovaries and a blood draw to assess hormone levels. Patients will be compensated $25 for their participation.

Studies of Other Conditions

Vulvodynia Focus Groups

Self-report measures of pain are useful for assessing outcomes in clinical trials and for monitoring patient response to an intervention in clinical care. In an effort to create a standard set of high quality self-report tools for pain and other symptoms of medical conditions, the NIH initiated the Patient-Reported Outcomes Measurement Information System (PROMIS©) network; however, a disease-specific outcome measure for vulvodynia pain was not developed as part of this initiative. This study looks to conduct focus groups as part of developing a self reported outcome measure for reported pain in women with vulvodynia.

Lichens

The goal of this study is to better elucidate the disease origins of lichen planus (LP) and lichen sclerosus (LS) with the long term goal of identifying more effective therapeutic targets. The current standard of treatment involves the topical application of steroids, which are not curative and have some undesirable side effects. Biopsy tissue will be collected from patients undergoing diagnostic work up for vulvar LP or LS. Each patient will receive $50 as compensation.

Post VVA Outcomes

It is estimated that vulvodynia, a common genital pain syndrome, affects between 8-15% of women over their lifetime. Vulvar vestibulectomy has proved an effective treatment for the condition, with studies citing over an 80% cure with surgery.3,4 Typical presentation of vulvodynia often coincides with the reproductive years and renders patients functionally infertile. Many of these patients will go on to conceive after their vestibulectomy. At this time, there is a dearth of data on post obstetrical outcomes after vestibulectomy. The purpose of this study is to estimate the frequency of pregnancy in these patients, as well as delivery method and ensuing complications factoring into choice of delivery method.

 

A current list of open clinical trials at the University of Rochester is available here.