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:  Clinical Evaluation of the Actim Partus Test.

Principal Investigator: Roger Newman, M.D.

Objective:  The objective of this study is to evaluate the ability of an investigational test to predict the risk of preterm or imminent delivery using cervical samples collected with a sterile swab from women less than 36 weeks pregnant and presenting with signs and/or symptoms suggestive of preterm labor and whose fetal membranes are not ruptured. The rapid test is called the Actim PARTUS test. It is an “investigational test”, which means that it is not approved by the U.S. Food and Drug Administration (FDA) and the results from the test cannot be used to assist in making a diagnosis. This study will collect information about the effectiveness of the rapid test to detect in a cervical sample a marker of fetal membrane detachment indicating a high risk of preterm or imminent delivery.

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.

Study Title:  Proteomic Assessment of Preterm Risk (PAPR).

Principal Investigator:  Scott Sullivan, M.D.

Objective:  The purpose of this study is to develop a test for the prediction of preterm delivery.

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:  Biomarkers of HPV Persistence in Cervical Cancer Patients.

Principal Investigator: Jennifer Pierce, M.D.

Objective:  The objective of this study is to look at the type of HPV linked with cervical cancer in European American women compared to African American women. At the time of pelvic examination as part of usual care, 2 extra Pap test samples will be collected. Patients may also donate a sample of cervical tumor tissue, a sample of blood and/or a sample of urine for the study.

General Obstetrics

Study Title:  Specimen Collection from Pregnant Women at Increased Risk for Fetal Chromosomal Aneuploidy for use in Development of a Noninvasive Fetal Aneuploidy Test.

Principal Investigator: Charles Rittenberg, M.D.

Objective:  The objective of this study is to collect specimens for the purpose of developing a prenatal aneuploidy test. The test will analyze circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have an increased risk indicator/s for fetal chromosomal aneuploidy and are undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploidy test will be compared to the chromosomal analysis obtained via CVS or genetic amniocentesis.

Study Title:  Detection of Intrauterine Growth Restriction Among Uncomplicated Pregnancy with Additional Ultrasounds in the Third Trimester: A Pilot Randomized Trial At 3 Centers.

Principal Investigator: Eugene Chang, 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:  A Clinical Study to Evaluate the Relative Clinical Specificity Performance of the SEQureDx® Trisomy 21 Test in Pregnant Women at Low Risk for Fetal Chromosome 21 Aneuploidy.

Principal Investigator: Eugene Chang, M.D.

Objective:  The objective of this study is to estimate the false positive rate of the SEQureDx Trisomy 21 Test versus birth outcome (Down syndrome or Unaffected/non-Down syndrome) in a population of pregnant women at low risk for fetal chromosome 21 aneuploidy.

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:  Prevalence and Clinical Significance of Mycoplasma Genitalium in our Gynecological Patients.

Principal Investigator:  Bassam Rimawi, M.D.

Objective:  The primary objective of this study is to investigate the prevalence of M. genitalium in women aged age 18 and older attending the Residents Continuity Clinics at Women’s Health Center and to determine the percentage of women diagnosed with cervicitis and PID who are M. genitalium positive.

Study Title:  Measuring the Association Between Improved Perinatal Outcomes, Board Certification and Maintenance of Certification (MOC).

Principal Investigator:  Scott Sullivan, M.D.

Objective:  The objective of this study is a population based analysis of perinatal outcome between physicians who have achieved ABOG certification, those who are participating in the MOC process and those who are not. 

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.

Study Title:  The CHIPS (Control of Hypertension In Pregnancy Study) Trial.

Principal Investigator:  Eugene Chang, M.D.

Objective:  The overarching hypothesis underlying CHIPS is that ‘less tight’ control may improve uteroplacental perfusion, fetal growth, and through these, fetal/neonatal well-being. We seek to determine whether ‘less tight’ control (target dBP of 100mmHg) vs. ‘tight’ control (target dBP of 85mmHg) of non-severe maternal hypertension will decrease fetal/neonatal risk without increasing maternal risk.

Study Title:  The National Standard for Normal Fetal Growth.

Principal Investigator:  Roger Newman, M.D.

Objective: 
The scope of this investigation is to study the fetal growth pattern in low risk and obese women of various racial/ethnic backgrounds in a longitudinal fashion to examine factors that influence normal fetal growth and perinatal outcomes. The research effort will fill important gaps in our knowledge about fetal growth. It will help identify important risk factors for altered growth and establish links between fetal growth, maternal nutrition, maternal metabolism, and other established maternal risk factors.

Study Title:  The National Standard for Normal Fetal Growth (TWINS).

Principal Investigator:  Roger Newman, M.D.

Objective:  The purpose of this study is to better understand how babies grow and develop inside the womb during a twin pregnancy. Normal growth of these babies is very important for a healthy pregnancy and the long-term health of these children. The primary goals of this study are to (1) describe ultrasound growth patterns in twin
pregnancies, and (2) compare growth patterns in twin pregnancies to those in single pregnancies. This knowledge may reduce and/or prevent pregnancy complications and newborn health problems.

Study Title:  Clinical Evaluation of the Actim PROM Test.

Principal Investigator:  Roger Newman, M.D.

Objective:  The purpose of this study is to evaluate the ability of an investigational device to help diagnose the rupture of fetal membranes (ROM) from vaginal samples collected using a swab.

Community Grant

Study Title:  Telemedicine Outreach Program.

Principal Investigator: 
Donna Johnson, M.D.

Objective:  The goal of this project is to reduce or delay preterm deliveries secondary to maternal medical complications in the Lowcountry Perinatal Region by extending specialized medical care to rural areas through telemedicine services.

Contraception

Study Title:  A Qualitative Study of the Influence of Trust in the Health Care System on Postpartum Contraceptive Choice.

Principal Investigator: Angela Dempsey, M.D.

Objective:  The objective of this study is to explore women’s views on choosing contraception during the postpartum period in the context of their health care locus of control, trust in their providers and health care system, and reproductive health messages that they received during antenatal and postpartum care. As a part of this study, a focus group is facilitated by a member of the research team during the postpartum period.

Study Title:  A Randomized Controlled Trial of Immediate versus Delayed Insertion of Implanon in Postpartum Adolescents.

Principal Investigator:  Angela Dempsey, M.D.

Objective:  The specific aim of this study is to evaluate whether insertion of a long-acting contraceptive implant in postpartum adolescents prior to hospital discharge increases use of this highly effective contraception during the first twelve months postpartum among adolescents who elect Implanon® as their preferred method of contraception.  Additionally, this study aims to compare the acceptability of bleeding in postpartum adolescents who have an etonorgestrel contraceptive implant prior to discharge versus those with insertion at the six week postpartum visit. We will evaluate the acceptability of bleeding rather than collect prospective diaries because we feel subjective perceptions of bleeding impact contraceptive continuation more than quantitative differences in bleeding.

Study Title:  Patterns of Contraceptive Use Among Post Partum Teenagers.

Principal Investigator:  Ashlyn Savage, M.D.

Objective:  The objective of this data analysis is to elucidate factors influencing post partum contraceptive choice, continuation, and risk of recurrent teen pregnancy.

Basic Science

Study Title:  Ecotoxicology of Alligators from Wild Populations in Florida and South Carolina.

Principal Investigator:  Louis Guillete, Ph.D.

Objective:  The objective of this study is to evaluate the relationship between contaminants and the reproductive health of female alligators.

General Gynecology

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:  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 purpose of this study is to:

  • Determine the rate of clearance of Chlamydia trachomatis DNA from the cervix during pregnancy following therapy

  • Determine evidence based timing for the test of cure in pregnant women treated for Chlamydia

  • Determine the effects of concurrent sexually transmitted infections on the clearance of Chlamydia

Study Title:  Effect of Patient Trust on Choice of Cervical Dysplasia Follow-up.

Principal Investigator:  Ashlyn Savage, M.D.

Objective:  The purpose of this study is to look at patient choice for follow up care and trust in the healthcare system.

Sexually Transmitted Disease/Infections

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.

Study Title:  Prospective Collection of Female First-catch Urine, Vaginal Swab, Cervical, and Endocervical Swab Specimens for Testing With the APTIMA Assays.

Principal Investigator: Gweneth Lazenby, M.D.

Objective:  The objective of this study is to obtain several specimens or samples from study participants. The specimens collected are the same samples collected during a standard visit to your doctor. These samples include urine and swabs from your vagina. These samples will be tested for diseases that are passed through sexual contact. These common diseases include gonorrhea, chlamydia, and trichomonas. The samples will be tested on instruments designed to test for sexually transmitted diseases (STDs). The data generated from testing these samples will be submitted to the Food and Drug Administration (FDA) to support the use of tests developed by the Gen-Probe, Inc. These name of these tests or assays are: 1) APTIMA COMBO 2 Assay and 2) APTIMA Trichomonas vaginalis Assay. These assays will be tested on instrument known as: 1) the PANTHER System and 2) the TIGRIS System.  By testing the samples using the APTIMA assays on these instruments this will help lead to increased detection and treatment of STDs

 
 
 

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