Sofia™ ROM FIA Specimen Procurement Protocol Save

Date Added
July 8th, 2014
PRO Number
Pro00028026
Researcher
David Soper
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

A developing fetus in the womb is surrounded by a sac made up of membranes containing amniotic fluid referred to as the amniotic sac. This amniotic sac aids in getting rid of fetal waste materials as well as provides a barrier against infection and allows the umbilical cord to float, preventing it from being compressed and cutting off the fetus’s supply of oxygen and nutrients. Just prior to or during labor the rupture of membranes (ROM) will occur in order for the fetus to be delivered. If rupture without labor occurs it places the mother and fetus at serious risk for infection, lung disease, compression of the umbilical cord cutting off oxygen and blood flow, and premature birth.

This research study will collect vaginal swab specimens from pregnant females that may have ruptured membranes. The purpose 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.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843.792.6323
yeadon@musc.edu

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

Date Added
April 18th, 2014
PRO Number
Pro00030991
Researcher
Krista Wagoner
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

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

Institution
MUSC
Recruitment Contact
Jesslyn Payne
843-792-1413
paynej@musc.edu

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

Date Added
April 14th, 2014
PRO Number
Pro00033466
Researcher
Sanjay Patwardhan
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

This study will look at abnormal blood circulation changes especially in the arteries supplying blood to the uterus (where the baby develops) using Doppler ultrasound. The research team will perform Doppler ultrasound scans at an early pregnancy scan and during the fetal anatomy scan to understand blood flow changes when subjects are lying on their back versus when they are tilted to their left and also when they bear down for 10 seconds.

Institution
MUSC
Recruitment Contact
Tamara Pfeffer
843.792.0316
pfeffer@musc.edu

Clinical Evaluation of the AmniSure ROM Test Save

Date Added
April 8th, 2014
PRO Number
Pro00025491
Researcher
Scott Sullivan
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose 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.

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

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

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