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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

Aqueductal Stenosis 

The purpose of this study is to determine how early and accurately we can diagnose a condition called aqueductal stenosis, which can cause ventriculomegaly. Ventriculomegaly is caused by a wide range of conditions. Aqueductal stenosis is a rare condition that requires very precise imaging to diagnose.  In this study, we ask if we may collect additional ultrasound images to determine how early we can successfully diagnose this condition.  There is no compensation for this study.

Cepheid GBS Testing 

The purpose of this study is to learn about a type of bacteria called Group B strep.  Normally we test for this bacteria at the end of pregnancy, and the results can take a few days.  This study is testing a new device to see if we can detect the bacteria in a few hours.  Patients who present to Labor and Delivery in labor may be asked to participate in this study.  The study involves taking two extra swabs from the rectal and vaginal area.  Patients will be paid $20 for participation.

Fructosamine Use In Pregnancy

‚ÄčThe purpose of this study is to study fructosamine, a marker in blood that tells how well controlled a patient’s diabetes is.  Current standard of care for diabetes in pregnancy requires glucose logs and regular monitoring of a patient’s HbA1c level.  However, HbA1c levels can be unreliable in pregnancy, and glucose logs are often difficult for patients to remember to complete.  Fructosamine has some early data that shows it may be better for monitoring than the current methods.  We would like to compare fructosamine levels with the current standard of care protocols.  Patients will be asked to complete 2 extra blood draws outside the standard of care 3 draws.  Patients will be compensated $20/blood draw, or $100 total for completing all study visits.

The GOOD Study 

GOOD is a study looking at the outcomes of patients born with gastroschisis. Families usually learn about their gastroschisis diagnosis while mom is still pregnant. Some doctors think that pregnancies complicated by gastroschisis should deliver early, while others think that moms should carry the baby until the mother begins labor.

There are risks and benefits to both times of delivery, and no scientific data exists to show if one delivery method is better than the other. The GOOD Study is designed to answer the question: should moms of a baby with gastroschisis deliver early or carry their babies closer to term?  There is no compensation for this study.

Misoprostol Pharmacokinetics

The purpose of this study is to learn if there are changes in blood levels of the medication Misoprostol in women with different body mass index to better understand how these differences may effect the process of induction of labor.  Patients will receive 3 extra blood draws after being given misoprostol for induction.  There is no compensation for this study.

Natera Twins Study 

This observational data collection study will include subjects with ultrasound-confirmed twin pregnancy and planned NIPS zygosity assessment as a part of their clinical care. Initial chorionicity assessment and, when available, planned twin pregnancy management (e.g., frequency of prenatal ultrasounds, maternal fetal medicine (MFM) referral etc) will be recorded in the study database. Following zygosity results being returned through clinical care NIPS, updated chorionicity & amnionicity will again be recorded in the study database. Other clinical data in the medical record as part of clinical care, including monochorionic twin pregnancy complications (TTTS, FTC referral, etc), placenta pathology findings, and delivery and neonatal outcomes will also be recorded in the study database. There will be no study blood sample collection or other study procedures performed as part of this study. 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.

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.

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.

"Fertility Studies"

NatPro is a two-arm, parallel-group, multi-center, randomized trial in which women undergoing FET will be randomized to receive either a modified natural cycle (corpus luteum present) or a programmed cycle (corpus luteum absent). The study will implement a stratified randomization design to balance the use of pre-implantation genetic testing (PGT) across the two treatment arms. Each participant will have up to 3 FET cycles until live birth occurs, or the participant has no embryos available for transfer. Primary endpoints will be the proportion of women experiencing preeclampsia comparing modified natural to programmed FET among women with viable pregnancy (defined as pregnancy lasting at least 20 weeks) and the cumulative proportion of women having live births in the two arms

Studies of Polycystic Ovarian Syndrome

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.

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