The effects of in utero exposure of antiretroviral therapy on neonate body fat distribution. Save

Date Added
April 4th, 2014
PRO Number
Pro00024418
Researcher
Gweneth Lazenby
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose 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, we will examine the differences in body fat distribution among ARV-exposed neonates comparing PI-exposed versus non-PI exposed.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843-792-6323
yeadon@musc.edu

Mobile Patient-Centered Preterm Birth Prevention Surveillance Program- UAM Validation Save

Date Added
March 7th, 2014
PRO Number
Pro00032491
Researcher
Roger Newman
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this project is to test the accuracy, acceptability and overall performance of a smart phone surveillance application (app) that is being developed to help prevent preterm birth. The smart phone app will measure contractions of pregnant women who are in labor. The results of the smart phone app will be compared with the results that are taken by the traditional machine that is used to measure contractions for women who are in labor.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843.792.6992
saundert@musc.edu

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 Save

Date Added
February 25th, 2014
PRO Number
Pro00010416
Researcher
Charles Rittenberg
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This is a multicenter, observational study.

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

Institution
MUSC
Recruitment Contact
Betty Oswald
843 792 0347
oswaldbw@musc.edu

Human Immunodeficiency Virus Testing in High Risk Obstetrical Patients: Guideline Adherence at the Center for Family Medicine Save

Date Added
February 17th, 2014
PRO Number
Pro00023696
Researcher
Nicole Warren
Keywords
Pregnancy
Summary

It is planned to perform chart reviews on patients delivered at Spartanburg Regional Healthcare System (SRHS) by CFM faculty and residents, in the six month period from July 2012 and December 2012, by examining the obstetrical ledger located at the Labor and Delivery Department at SRHS. In addition, obstetrical patients who were being followed by CFM faculty and residents through to the third trimester during this period, but who may not have delivered by the end of the six month period, will also be included. These patients will then be evaluated in the Centricity database for records of prenatal and perinatal testing of HIV, using glucola tests, group B streptococcus screening orders, as search criteria to identify patients in the third trimester. Perinatal testing is defined for our purposes, as being in the third trimester of pregnancy. In addition, this patient population will also be chart audited for any history of sexually transmitted infection (STI) documented within the past year, as well as any diagnosis or documented problem of high risk sexual activity. The results of prenatal versus perinatal testing statistics will then be compared to evaluate adherence to these consensus guidelines at the CFM.
Prior to this chart review, obstetrical and HIV statistics from the state of South Carolina, as well as Spartanburg County, were reviewed and compared to confirm this jurisdiction as an area of high HIV prevalence. Population statistics were obtained from the South Carolina Department of Health and Environmental Control (SC DHEC). ACOG, AAP, AAFP, and CDC guidelines were also extensively reviewed to confirm consensus guidelines recommending perinatal HIV testing in the third trimester to prevent neonatal HIV transmission.

Institution
Spartanburg
Recruitment Contact
Nicole Warren
7062482413
nwarren2@srhs.com

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 Save

Date Added
February 11th, 2014
PRO Number
Pro00029481
Researcher
David Soper
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Norvartis Vaccines and Diagnostics (NVD) is studying a vaccine for the prevention of Group B streptococcus (GBS) disease in babies. This is a common disease passed along to baby during birth, and that the purpose of the vaccine is to prevent this from happening, keeping baby from getting a GBS infection. This study is being conducted to learn more about the safety and immune response (how the vaccine works) of the vaccine in pregnant women and their babies.

Institution
MUSC
Recruitment Contact
Betty Oswald
843.792.0347
oswaldbw@musc.edu

Differences in the migration and cell surface marker expression of Mesenchymal Stem Cells (MSC) obtained from the placenta and Umbilical Cord Blood Save

Date Added
December 6th, 2013
PRO Number
Pro00009198
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to determine whether there are alterations in the migration and cell surface marker expression of MSC’s obtained from the placenta and umbilical cord in uncomplicated pregnancies

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
cordells@musc.edu

Alterations in the Plasma Proteome of Early-Onset Severe Preeclampsia Save

Date Added
December 20th, 2011
IRB Number
17495
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to see if there are proteins in your blood or urine that may help researchers better understand why pregnant women develop preeclampsia (a special form of high blood pressure that affects only pregnant women).

If you agree to be in this study, the following will happen for control subjects.
1. At the time of enrolling in this study, you will be asked to donate 2 tablespoons of blood and 7 tablespoons of urine.
2. The researchers will check your medical records to gather information about your pregnancy and your delivery. We will collect information such as height, weight, age, and lab work. In addition, we will collect information from your baby’s medical records from their birth until their discharge.
If you agree to be in this study, the following will happen for the preeclampsia subjects.
1. At the time of enrolling in this study, you will be asked to donate 2 tablespoons of blood and 7 tablespoons of urine.
2. Following delivery of the baby and placenta (afterbirth), a 1.25 x x1.25 inch sample of the afterbirth will be collected for study.
3. 24 to 72 hours following delivery, you will be asked to donate 2 tablespoons of blood and 7 tablespoons of urine.
4. The researchers will check your medical records to gather information about your pregnancy and your delivery. We will collect information such as height, weight, age. In addition, we will collect information from your baby’s medical records from their birth until their discharge.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
saundert@musc.edu

A comparison of sterile and non-sterile gloves for the incidence of chorioamnionitis during labor: a randomized, controlled trial Save

Date Added
December 19th, 2011
IRB Number
20638
Researcher
Scott Sullivan
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to determine whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis.

When labor exams are needed, the examiner will either use a sterile or a clean glove. Sterile gloves come from a separate package, and clean gloves come from a box. Both are medical gloves, and both are considered clean and safe to use. During labor, a number of factors will be recorded, such as gestational age, timing of rupture of membranes, number of exams, type of delivery, and rate of infection. At birth, several factors will be recorded from the baby, such as Apgar scores, birthweight, infection rate, and infection work-up.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
saundert@musc.edu

The Effects of Maternal Phthalate and Bisphenol A Exposure on Fetal Genital Development Save

Date Added
December 19th, 2011
IRB Number
20312
Researcher
Roger Newman
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to determine if exposure to certain chemicals by the mother affects the size of your baby’s genitals.

At the time of enrollment, a maternal urine sample will be collected and tested for bisphenol A and phthalate metabolites, organic compounds that can be found in your urine. This urine sample will be about 80 ml or 5 tablespoons. A blood sample will also be collected at enrollment. This blood sample will be about 30 ml or 2 tablespoons. There is very important information that can be gained by collecting your blood sample and you contribution to this study would be greatly appreciated. However, if you choose not to supply a blood sample, you can still participate in the other portions of the study. If you do not want to participate in the blood collection portion of the study, please notify the study staff. You will also be asked to complete a questionnaire that will allow Dr. Unal and the research staff to have a better idea of your everyday life and your contact with plastic. The questionnaire will be given to you by the study staff at the time of enrollment in the study.

Regardless of where you plan to deliver your baby, if it is determined that you are having a boy during your fetal anatomic ultrasound, we will measure the length and width of your baby's penis. The measurements will be taken using the high resolution picture created by the ultrasound. If it is determined that you are having a girl no measurements will be taken during the ultrasound.

During your scheduled office vist between 24 and 32 weeks gestation, you will be asked to provide a 2nd urine sample. This urine sample will be about 80 ml or 5 tablespoons.

If you plan to deliver at MUSC, then the following procedures will take place after delivery:
At the time of delivery appproximately 15 ml or 1 tablespoon of fetal cord blood will be collected; this does not involve a needle-stick to the baby as the blood is collected directly from the umbilical cord after the placenta is delivered. In addition, approximately 30 ml or 2 tablespoons (two extra tubes of blood) will be collected at the time of IV placement. This blood sample will not involve a needle-stick. Also at the time of delivery an additional maternal urine sample (about 80 ml or 5 tablespoons) will be taken. These samples will be stored for later analysis of bisphenol A, phthalate metabolites, and androgens, which are male hormones.

Genital measurements will also be taken of your baby.

Institution
MUSC
Recruitment Contact
Ashlyn Boserup
843-792-0355
hunas@musc.edu

The CHIPS (Control of Hypertension In Pregnancy Study) Trial Save

Date Added
December 19th, 2011
IRB Number
19124
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to determine whether ‘less tight’ control (aiming for a diastolic blood pressure of 100 mmHg), compared with ‘tight’ control (aiming for a diastolic blood pressure of 85 mmHg), can decrease the risks of adverse (unwanted) baby outcomes without increasing the risk of problems for the mother. The diastolic blood pressure is the bottom number of the blood pressure reading, and is less influenced by what is going on around a woman.

Institution
MUSC
Recruitment Contact
Tamara Saunders
843-792-6992
saundert@musc.edu