CURRENT RESEARCH STUDIES |
Preeclampsia Studies | Pre-Term Labor Studies | Inflammation Studies | Contraceptive Studies |
Urogynecology | Oncology Studies | General Obstetrics | Community Grant |
| Basic Science | General Gynecology |
Preeclampsia Studies |
Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia CTSA K-12 Scholar The objective of this study is to:
Compare the maternal plasma proteomes of early-onset, severe preeclampsia versus healthy controls. Compare protein expression and quantification of the maternal plasma proteome at the time of diagnosis of EOS-preeclampsia to the plasma proteome of the same affected subject at 48 hours post delivery. Verify the placental expression of differentially expressed of post-translationally modified proteins found in the plasma of women with EOS-preeclampsia.
|  Christopher Robinson, MD
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Pre-Eclampsia Triage by Rapid Assay (PETRA) of Novel Biomarkers of Placental Function and Maternal Adaptation The purpose of this study is to see if a protein called PlGF can be detected in the patients blood and be used to predict whether or not the patient will develop pre-eclampsia during or after this pregnancy. This goal is to develop a diagnostic test called Triage PlGF Test, for pre-eclampsia in pregnant women. |
Sample Collection Study for the Assessment of Novel Biomarkers of Placental Function and Maternal Adaptation in Healthy Pregnant Women without Pre-eclampsia The purpose of this study is to see if a protein called PlGF can be detected in the patients blood and be used to predict whether or not the patient will develop pre-eclampsia during or after this pregnancy. This goal is to develop a diagnostic test called Triage PlGF Test, for pre-eclampsia in pregnant women. |
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.
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. |  Eugene Chang, MD
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Early Placental Markers of Preeclampsia The purpose of this study is to examine substances in the placenta that may increase the risk of preeclampsia. The study will compare the early placental tissue from women who have had normal, full term pregnancies to the placentas of women who have had a pregnancy (pregnancies) complicated by high blood pressure/or preeclampsia. |  Mark Alanis, MD
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Pre-Term Labor Studies |
Progesterone Outreach Project The primary objective of the Progesterone Outreach Project (POP) is to increase the appropriate administration of 17-p hydroxyprogesterone appropriate (17P) to women in the Lowcountry Perinatal Region (Charleston, Berkeley, Dorchester, Colleton, Georgetown, Beaufort, Jasper, and Hampton counties) with a history of spontaneous preterm birth by aggressive and consistent educational outreach to all Regional obstetrical providers. |  Charles Rittenberg, MD
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The oncoFISH Cervical Test for Detection of 3q26 Region Gain The objective of this study is to evaluate the use of the oncoFISH cervical Microscopy Test System, utilizing automated counting of fluorescence in situ hybridization (FISH) signals for the 3q26 region and chromosome enumeration probe (CEP) 7 (the latter as a control) in cervical specimens from patients with low-grade squamous intraepithelial lesions (LSIL). The results of the colposcopical assessment (colposcopy/biopsy) at 12 months for those LSIL patients with initial negative colposcopy/biopsy results will be correlated with the oncoFISH results done at initial LSIL diagnosis.
|  Scott Sullivan, MD
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Preventing preterm labor in low resource settings The objective of this study is to build and test a vaginal pessary that elutes 17-alpha hydroxyprogesterone caproate (17-OHP) over a twenty week period to prevent preterm delivery in low resource settings. The device would be shelf-stable, inexpensive, easily shipped and could be inserted either by patients themselves or by health attendants if available. It provides structural support to the maternal cervix and provides a steady concentration of 17-OHP throughout the critical weeks of pregnancy where inflammation and cervical shortening can lead to preterm delivery. |
Proteomic Assessment of Preterm Risk (PAPR) The purpose of this study is to develop a test for the prediction of preterm delivery. |
Inflammation Studies |
Risk of Neuroinflammation and Programmed Cognitive Impairment as a Result of In Utero Exposure to Trans-Unsaturated Fatty Acids Through Maternal Diet SMFM Scholar The purpose of this study is to identify the toxic fetal effects of maternal exposures to trans fatty acids, a common dietary component of obese women. |  Mark Alanis, MD
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Urogynecology |
A 12-Week, Phase 4, Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Trial In Overactive Bladder Subjects To Confirm The Efficacy Of 8 Mg Fesoterodine Compared To 4 Mg Fesoterodine The purpose of this research study is to compare the effectiveness of two doses of a drug called fesoterodine or placebo (a substance that contains no active ingredient but looks identical to the study drug) for overactive bladder. |

Steven Swift, MD |
Oncology Studies |
Hollings Cancer Center Clinical Trials |
Matthew Kohler, MD
 William Creasman, MD Jennifer Young-Pierce, MD 
Whitney Graybill, MD |
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General Obstetrics |
MELISSA Study: matErnal BLood IS Source to Accurately diagnose fetal aneuploidy: A prospective, multi-enter observational study with blinded, nested case The purpose of this research is to determine how well a new prenatal blood test performs at diagnosing an abnormal number of chromosomes, or aneuploidy, in a developing fetus compared to results from CVS and amniocentesis | 
Donna Johnson, MD |
The EXPEDITE Study: A phase III, double-blind, randomized, multicenter study of EXogenous Prostaglandin comparing the Efficacy and safety of the Misoprostol Vaginal Insert (MVI) 200 mcg to the Dinoprostone vaginal Insert for reducing Time to vaginal delivery in pregnant women at tErm The purpose of this study is to evaluate the effectiveness and safety of the 200 mcg reservoir of misoprostol in a vaginal insert (MVI 200). Misoprostol is a drug that is currently used to treat stomach ulcers, and is available as a medication called Cytotec. It has been shown to be effective at inducing (starting) labor when taken by mouth or broken into pieces and put into the vagina, and some obstetricians have used it for this purpose. | 
Laura Goetzl, MD |
A comparison of sterile and non-sterile gloves for the incidence of chorioamnionitis during labor: a randomized controlled trial. 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. | 
Laura Houston, MD |
Prevalence and clinical significance of Mycoplasma genitalium in our gynecological patients 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. | 
Oluwatosin Jaiyeoba, MD |
Epidemiology of southern women seeking HIV/AIDS care at MUSC ID clinic from 2005 to 2010 The primary objective of this study is to characterize the demographics and clinical characteristics of women seeking HIV care in our Infectious Diseases Clinic at MUSC in the past 5 years (2005-2010). To document using their zip codes, the county of residence and the miles travelled in order to receive HIV care. Abstract the CD4 count and viral load at presentation to the clinic, trend their immunologic and virologic response to antiretroviral therapy (ART). This study will also document any co-morbidities and presence of opportunistic infections at initiation of care. |
Correlation between health care workers (HCW) knowledge of the Influenza vaccine and vaccine uptake at Medical University of South Carolina Hospital (MUSC). The objectives of this study are to: Test the knowledge of HCW regarding influenza virus Test the knowledge of HCW regarding Influenza vaccine Identify barriers to vaccine uptake |
Measuring the association between improved perinatal outcomes, board certification and maintenance of certification 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. | 
Scott Sullivan, MD |
Predictors of Successful Induction in Nulliparous Patients at Term The objective of this study is to identify new biomarkers for the prediction of successful labor induction and to quantify the sensitivity and specificity of these biomarkers. |  Elizabeth Unal, MD
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The Effects of Maternal Phthalate and Bisphenol A Exposure on Fetal Genital Development 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. |
The CHIPS (Control of Hypertension In Pregnancy Study) Trial 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. |  Eugene Chang, MD
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Evaluation of the Performance of a Noninvasive Test for Fetal RHD Genotype This investigational study will be performed for the purpose of collecting specimens which will be used to establish the performance of a noninvasive test for fetal RHD genotype in support of a marketing application with the U.S. FDA or other worldwide regulatory authority. |  Christopher Robinson, MD
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Collection of Biological Specimens from Pregnant Women to Support Research and Development The purpose of this study is to collect whole blood samples from pregnant women for research and development of prenatal diagnostic tests of fetal trisomy. |
Collection of Whole Blood Specimens from Pregnant Women at Increased-Risk for Fetal Chromosomal Aneuploidy Primary: 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. Secondary: To collect samples for the purpose of developing prenatal tests for aneuploidies that are less common than Trisomy 21 (T21). |
Investigational Study of a Prenatal Diagnostic Test for Fetal Aneuploidy The purpose of this research is to find out whether analyzing DNA in a mother’s blood can be used to identify pregnancies with normal chromosomes and pregnancies with chromosome abnormalities such as Down syndrome. |
The BD-OTS Post-Marketing Surveillance Program The objective of this study is to assess the overall benefit and safety (including risk of uterine rupture) of the BD-OTS in actual clinical practice. |
The National Standard for Normal Fetal Growth 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. Fetal Growth Study Flyer |  Roger Newman, MD
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The National Standard for Normal Fetal Growth (TWINS) 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. |
Clinical Evaluation of the Actim PROM test 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. |
Identifying Intrauterine Growth Restriction Using Air-Displacement Plethysmography Measurement of Early Postnatal Body Composition
The purpose of this study is to: Identify near term fetuses with suspected intrauterine growth restriction based on overall estimated fetal weight less than the 10th %ile, abdominal circumference less than the 5th %ile or abnormal umbilical artery doppler velocimetry. Identify which ultrasound parameter used to identify suspected intrauterine growth restriction is most predictive of abnormal fetal body fat accrual based on early postnatal air-displacement plethysmography. Identify the relationship between neonatal body fat accrual measurements by air-displacement plethysmography and directly measured neonatal anthropometrics (body weight, length, head and abdominal circumferences) and derived neonatal anthropometric measurements (body mass indes, ponderal index, and head to abdomen ratios). Identify which fetuses undergoing more than one ultrasound examination in the third trimester will have abnormalities of fetal growth velocity over time that is highly predictive of abnormal fetal body fat accrual. Identify adverse obstetrical and neonatal outcomes of all enrolled maternal/infant pairs and correlate those morbidities with the neonatal body fat percentage.
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Investigating Differences in Twin and Triplet Growth The purpose of this study it to: Determine the correlation between the discordance of estimated fetal weight of twins and triplets in utero assessed by ultrasound and the discordance of body composition of the infants after birth assessed by air displacement plethysmography. Identify twin or triplet gestations with weight discordance of 20% or more based on in utero ultrasound measurements.As well as identify which ultrasound parameter of weight discordance for twin or triplet gestation is most predictive of abnormal fetal body fat accrual based on early postnatal air-displacement plethysmography. Identify adverse obstetrical and neonatal outcomes of all enrolled maternal/infant pairs and correlate those morbidities with the neonatal body fat percentage.
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Obesity-Related Alterations in Placental Development and Function The purpose of the study is to see if there is a relationship between body weight and the function of the placenta. The study will compare the early placental tissue between obese and non-obese women. |  Mark Alanis, MD
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Community Grant |
Spaulding-Paolozzi Community Outreach Project The objective of this project is to extend prenatal education to underprivileged, socioeconomically disadvantaged patients and to continue providing healthcare services by supporting clinical personnel. | 
Peter Van Dorsten, MD |
Telemedicine Outreach Program The goal of this project is to reduce or delay preterm deliveries secondary to maternal medical complications in the Low Country Perinatal Region by extending specialized medical care to rural areas through telemedicine services. | 
Donna Johnson, MD |
Developing Quality Student Athletes in Charleston County Public Elementary Schools The objective of this project is to evaluate the impact of a combined mentoring, physical activity, and lifestyle behavioral intervention targeted to inner city elementary school aged boys and girls. The project is a collaboration between the Charleston County School District (CCSD), the Medical University of South Carolina (MUSC), the DAE Foundation (Charleston community organization) and College of Charleston Athletics. | 
Roger Newman, MD |
Contraceptive Studies |
A Randomized Controlled Trial of Immediate versus Delayed Insertion of Implanon in Postpartum Adolescents
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. |  Angela Dempsey, MD
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Patterns of Contraceptive Use Among Post Partum Teenagers The objective of this data analysis is to elucidate factors influencing post partum contraceptive choice, continuation, and risk of recurrent teen pregnancy. | 
Ashlyn H. Savage, MD |
Basic Science |
Ecotoxicology of alligators from wild populations in Florida and South Carolina The objective of this study is to evaluate the relationship between contaminants and the reproductive health of female alligators. | 
Louis Guillette, Ph. D. |
General Gynecology |
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 The purpose of this study is to test the safety and effectiveness of the 9-valent HPV as compared to GARDASIL®. Study Advertisement |  David Soper, MD
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A Clinical Correlation of Vaginal Leukorrhea to the Diagnosis of Trichmonas Vaginalis The specific aim of this study is to determine the incidence of Trichomonas infection in the MUSC population presenting with symptoms, signs, or risk factors of vaginitis and leukorrhea noted at the time of microscopy of the vaginal secretions. Additionally, this study aims to demonstrate improved detection with a nucleic acid amplification method based on transcription mediated amplification (6,7) over microscopy and culture.
|  Gweneth Lazenby, MD
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Clearance of Chlamydia trachomatis following treatment during pregnancy in order to determine timing of test of cure 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
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Maternal and Neonatal Methicillin-Resistant Staphylococcus Aureus Colonization Screening during Admission for Preterm Labor The purpose of this study is to: Determine possible transmission of MRSA to neonates from mothers in preterm labor or with premature rupture of membranes Determine if maternal decolonization of MRSA carriage decreases neonatal MRSA rates
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Effect of Patient Trust on Choice of Cervical Dysplasia Follow-up The purpose of this study is to look at patient choice for follow up care and trust in the healthcare system. | 
Ashlyn H. Savage, MD |