MUSC Women's Care

musc women's care

Research, Grants, & Clinical Trials

Current Research Studies

PreeclampsiaPre-Term LaborInflammationContraceptionCommunity Grant
Basic ScienceOncologyGeneral ObstetricsGeneral GynecologySexually Transmitted Disease/Infections

Preeclampsia

Study Title:  Placental Markers of Endoplasmic Stress / Unfolded Protein Response in Preeclampsia and IUGR.

Principal Investigator: Eugene Chang, M.D.

Objective:  The objective of this study is to determine whether there are differences in the placenta, or afterbirth, in women who have had an uncomplicated normal birth, compared to women who had babies who had restriction of normal growth or women who have experienced symptoms of preeclampsia.

Study Title:  Endothelial Progenitor Cells in Umbilical Cord Blood in Preeclamspsia and IUGR and the Effects of Kallistatin on the Migration, Proliferation and Survival of these Cells.

Principal Investigator:  Eugene Chang, M.D.

Objective:  The objective of this study is to determine whether there are alterations in the population of stem cells in umbilical cord blood samples of infants born in the setting of preeclampsia or fetal growth restriction. The effects of Kallistatin on these cells will also be determined.

Pre-Term Labor

Study Title:  Clinical Evaluation of the AmniSure ROM Test.

Principal Investigator: Scott Sullivan, M.D.

Objective:  The objective of this study is to evaluate whether the AmniSure ROM (Rupture of [fetal] Membrane) test read by personnel in the subject’s room gives the same result as the AmniSure ROM test read in a laboratory. Researchers will then look to see how both results compare to the results of three standard test methods to detect ruptured (broken) fetal membranes (rupture of the sac where the fetus develops). These standard tests are called nitrazine, ferning, and pooling.

Study Title:  Sofia™ ROM FIA Specimen Procurement Protocol.

Principal Investigator: David Soper, M.D.

Objective:  The objective of this study is to provide vaginal swab specimens to Quidel Corporation to assist them in the development of a test to aid in the detection of amniotic fluid in the vagina.

Study Title:  Prospective Phase III Evaluation of Fetal Fibronectine in a High Risk Asymptomatic Population for the Prediction of Spontaneous Preterm Birth.

Principal Investigator:  Eugene Chang, M.D.

Objective:  The objective of this study is to evaluate the benefits of collecting FN measurements from a vaginal fluid specimen taken during early pregnancy (from 16 weeks to 22 weeks) to assess the risk of pre-term birth.

Inflammation

Study Title:  Maternal Epidural Steroids to Prevent Neonatal Exposure to Hyperthermia and Inflammation.

Principal Investigator: Christopher Goodier, M.D.

Objective:  The objective of this study is to determine if prophylactic epidural steroids decrease the fetal exposure to hyperthermia and inflammatory cytokines associated with epidural analgesia.

Oncology

Hollings Cancer Center Clinical Trials

Study Title:  A pilot study evaluating vitamin D deficiency and risk of aggressive uterine cancer in African American as compared to White women

Principal Investigator: Whitney Graybill, M.D.

Objective:  The purpose of this study is to evaluate vitamin D levels in African American and White women who present with a new diagnosis of uterine cancer.

Study Title:  A Pilot Study Evaluating Racial Disparity, Environmental Toxin Exposure and Regulation of Anti-Inflammatory Mediators as Risk Factors for Endometrial Carcinogenesis

Principal Investigator: Whitney Graybill, M.D.

Objective:  The purpose of this study is to determine if environmental toxin exposure differs in African American women as compared to White women with endometrial cancer and to evaluate the relationship between demographic variables and toxin level.

General Obstetrics

Study Title:  Effect of left lateral position and Valsalva maneuver on uterine artery Pulsatility and Resistance indices in first and second trimester of pregnancy.

Principal Investigator: Sanjay Patwardhan, MD

Objective:  The main objective of this study is to identify whether maternal positional change and Valsalva maneuver result in changes in the Pulsatility Index and Resistance Index of the uterine artery in the 1st and 2nd trimester of pregnancy. Secondary aim is to determine whether lack of change in Doppler indices is predictive of early onset preeclampsia.

Study Title:  Assessing the Potential of a Home-Based Prenatal Care Model by Comparing Patient to Provider Measurements

Principal Investigator: David Soper, M.D. and Krista Wagoner, MD

Objective:  The objective of this study is to compare routine prenatal measurements taken by patients to the same measurements that are taken by the provider.

Study Title:  A Phase II, Multicenter, Randomized, Observer-Blind, Controlled Study to Evaluate Safety and Immunogenicity of a Trivalent Group B Streptococcus Vaccine in Healthy Pregnant Women

Principal Investigator: David Soper, M.D.

Objective:  The objective of this study is to assess: 1) how many women with non-complicated singleton pregnancies need to be screened to enroll one patient in the trial; 2) how many sonographic (ultrasound) examinations are done in the group which get routine care; 3) the number of women who complete the study; 4) the likelihood of detecting IUGR in both arm of the trial; and 5) the mother and newborns outcomes in each arms of the study.

Study Title:  Determine the Effect of Cultured Endothelial Progenitor Cells from Normal Human Cord Blood on the Protection of Mice from Cecal Ligation Puncture-Induced Sepsis.

Principal Investigator: Eugene Chang, M.D.

Objective:  The objective of this study is to study cells that are found in the cord blood of pregnant women to see if they might be helpful in treating certain types of infections.

Study Title:  Collection of Whole Blood Specimens from Pregnant Women at Increased Risk for Fetal Chromosomal Abnormality for use in Development of a Noninvasive Prenatal Test in the Detection of the Relative Quantity of Chromosomal Material in Circulating Cell-Free DNA Extracted from Maternal Plasma

Principal Investigator: Charles Rittenberg, M.D.

Objective:  This research study will test whether the methods being developed for the detection of fetal abnormality from samples of maternal blood can be used in the laboratory and employed in clinical practice

Study Title:  Fertility, Environmental Contaminants and the Developing Ovarian Follicle.

Principal Investigator: Louis Guillette, Ph.D.

Objective:  The objective of this study is to look at potential correlation between environmental contaminants and infertility.

Study Title:  A Comparison of Sterile and Non-sterile Gloves for the Incidence of Chorioamnionitis During Labor: a Randomized Controlled Trial.

Principal Investigator:  Scott Sullivan, M.D.

Objective:  The objective of this project is to evaluate the rate of clinical chorioamnionitis using either sterile or clean, non-sterile gloves for intrapartum vaginal exams.

Study Title:  The Effects of Maternal Phthalate and Bisphenol A Exposure on Fetal Genital Development.

Principal Investigator:  Roger Newman, M.D.

Objective:  The overall goal of this study is to extend to the human fetus the association between maternal bisphenol A and phthalate exposure and altered fetal genital development that has been demonstrated in animal studies and, in the case of phthalates, in human male infants.

General Gynecology

Study Title: A Randomized, Double-Blind, Parallel-Group, Placebo- and Active-Controlled, Multi-center Study to Evaluate the Efficacy, Safety and Tolerability of Combinations of Solifenacin Succinate and Mirabegron Compared to Solifenacin Succinate and Mirabegron Monotherapy in the Treatment of Overactive Bladder

Principal Investigator:  Steven Swift, M.D.

Objective: The purpose of this study is to examine how well two medicines given together (solifenacin succinate and mirabegron) work in the treatment of overactive bladder problems (such as frequency and urgency) over an 18-week period. Both these medications have already been shown to be well tolerated and effective in treating OAB if given separately.

Study Title:  A Randomized, Placebo-Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of Ulipristal Acetate for the Intermittent Treatment of Abnormal Uterine Bleeding Associated with Leiomyomas

Principal Investigator:  David Soper, M.D.

Objective: Watson Lab is studying an investigational drug, Ulipristal Acetate (UPA), to determine if given at two different dose levels, is safe and effective in stopping heavy bleeding in women with uterine fibroids. This study will also see if UPA is effective in relieving the symptoms of uterine fibroids, reducing the size of the fibroids, and improving the subject’s quality of life.

Sexually Transmitted Disease/Infections

Study Title:  A Randomized, International, Double-Blinded (With In-House Blinding),Controlled With GARDASIL(TM), Dose-Ranging, Tolerability, Immunogenicity, and Efficacy Study of a Multivalent Human Papillomavirus (HPV) L1 Virus-Like Particle (VLP) Vaccine Administered to 16- to 26-Year-Old Women.

Principal Investigator:  David Soper, M.D.

Objective:  The purpose of this study is to test the safety and effectiveness of the 9-valent HPV as compared to GARDASIL®.

Study Title:  A Randomized, Double-Blind, Factorial Study to Compare the Safety and Efficacy of Varying Combinations of GEN-003 and Matrix-M2 in Subjects with Genital HSV-2 Infection.

Principal Investigator: David Soper, M.D.

Objective:  This study involves an investigational therapeutic vaccine (a medical product) that is being tested for the treatment of genital herpes infection. The purpose of this research study is to see which of 6 dose combinations of the study vaccine can best reduce the amount of HSV-2 in a person's genital area (viral shedding). Other purposes of the study are to 1) see how safe and tolerable the study vaccine is, and 2) to see how the study vaccine affects a person's immune system.

Study Title:  The Effects of In Utero Exposure of Antiretroviral Therapy on Neonate Body Fat Distribution.

Principal Investigator: Gweneth Lazenby, M.D.

Objective:  The objective of this study is to compare body fat distribution in neonates exposed to antiretroviral (ARV) therapy for the prevention of maternal to child transmission (MTCT) of HIV versus ARV naive neonates born at a similar gestational age to HIV-negative women. As a secondary analysis, researchers will examine the differences in body fat distribution among ARV-exposed neonates comparing PI-exposed versus non-PI exposed.

Study Title:  Clearance of Chlamydia Trachomatis Following Treatment During Pregnancy in Order to Determine Timing of Test of Cure.

Principal Investigator: Gweneth Lazenby, M.D.

Objective:  The objective of this study is to: (1) determine the rate of clearance of Chlamydia trachomatis DNA from the cervix during pregnancy following therapy; (2) determine evidence based timing for the test of cure in pregnant women treated for Chlamydia; and (3) determine the effects of concurrent sexually transmitted infections on the clearance of Chlamydia.

Community Grant

Contraception

Basic Science

 
 
 

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