The Contribution of Gut Microbiota to Prenatal Methylmercury Exposure Save

Date Added
August 5th, 2014
PRO Number
Pro00036191
Researcher
Carol Wagner
Keywords
Nutrition, Pregnancy
Summary

The human gut hosts trillions of microbes, more than any other ecosystem, making this an important reservoir for microbial mercury cycling. Genes associated with both inorganic mercury methylation and methylmercury demethylation were isolated from human feces, indicating the importance of both processes during digestion and elimination. Our primary hypothesis is that differences in the taxonomic abundance and diversity of maternal gut microbiota impact prenatal methylmercury exposure via at least two possible mechanisms: 1) alteration of the metabolic potency of gut microbes to detoxify methylmercury and enhance its fecal excretion, and/or 2) alteration of the enterohepatic cycling of methylmercury through changes in intestinal permeability and resultant uptake of methylmercury into systemic circulation, potentially impacting the central nervous system and distribution to tissues.

We will test this hypothesis within a cohort of 130 pregnant women and their offspring, who will be recruited at the at the Medical University of South Carolina, located in the coastal city of Charleston, South Carolina. This longitudinal study will establish the relationship between gut ecology and prenatal methylmercury exposure at four time points, targeting prenatal and postnatal periods when shifts in gut microbiota will likely occur, including trimesters 1 (or 2) and 3, delivery, and 18 months postpartum. Through a combination of biomarker assessment (hair, blood, meconium, stools, and urine) and gene profiling of maternal and infant stool samples, the proposed research will advance our understanding of methylmercury metabolism, including impacts to prenatal methylmercury exposure.

Institution
MUSC
Recruitment Contact
Kaleena Dezsi
(843) 670-8289
dezsi@musc.edu

PROSPECTIVE PHASE III EVALUATION OF FETAL FIBRONECTIN IN A HIGH RISK ASYMPTOMATIC POPULATION FOR THE PREDICTION OF SPONTANEOUS PRETERM BIRTH Save

Date Added
July 22nd, 2014
PRO Number
Pro00026710
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

Fetal fibronectin (also known as fFN) is a “glue-like” protein that bonds your developing baby to your uterus. Fetal fibronectin is detectable in vaginal secretions in the very beginning of pregnancy, when this bond is first forming, and then again at the end of pregnancy, when your body is getting ready to deliver your baby.

fFN is a special protein that literally holds your baby in place in the womb. After the 35th week of pregnancy, it begins to break down naturally, and is detectable. If your body is getting ready to give birth prematurely, fFN may be detected before week 35.

Identifying women at high risk of giving birth prematurely can be challenging. It is believed that higher levels of fFn measured in vaginal fluid suggest a woman is at a greater risk for delivering early. fFN testing is already approved for use in women from weeks 22 to 35 of pregnancy.

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

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

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

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

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