A comparison of remote prenatal care versus routine in-office visits for low-risk obstetric patients Save

Date Added
November 19th, 2015
PRO Number
Pro00047817
Researcher
Donna Johnson
Keywords
Obstetrics and Gynecology, Pregnancy
Summary

This study will evaluate a remote patient monitoring solution for low-risk pregnancies to assess whether or not it produces equivalent care with regards to clinical outcomes and patient satisfaction at a lower cost to the healthcare system and its participants. Furthermore, we will measure the ability of participants to collect and record the necessary data.

Institution
MUSC
Recruitment Contact
Shelby Neal
843-792-4500
nealsa@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
November 18th, 2015
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

Mesenchymal Stem Cells (MSC) obtained from Healthy Donor Umbilical Cords Save

Date Added
November 4th, 2015
PRO Number
Pro00037760
Researcher
Gary Gilkeson
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to obtain viable mesenchymal stem cells (MSCs) from umbilical cords in uncomplicated pregnancies. Potential donors will be screened prior to donation of umbilical cords to confirm no prevalent autoimmune disease or other viruses and/or diseases. The overall goal is to obtain MSCs from healthy donors for eventual transfusion into patients for the treatment of autoimmune disease, specifically systemic lupus erythematosus.

Institution
MUSC
Recruitment Contact
Eden Gebre
843-792-6043
gebre@musc.edu

Childhood Adversity, Stress-Reactivity and Risk of Poor Obstetric Outcomes in African American Women Save

Date Added
November 3rd, 2015
PRO Number
Pro00038009
Researcher
Constance Guille
Keywords
Pregnancy
Summary

This study is looking at how increased number of stressful life events and perceived racial discrimination and might affect outcomes in pregnancy for African American women. We are recruiting African American pregnant women to be in the study, which will involve answering questions about stressful events occurring in childhood and adulthood, and will measure responses to stressful events and monitor outcomes of the pregnancy.

Institution
MUSC
Recruitment Contact
Kimberly Leslie
843-792-0403
hammonk@musc.edu

Preventing Health Disparities during Pregnancy through Vitamin D Supplementation Save

Date Added
November 3rd, 2015
PRO Number
Pro00020570
Researcher
Carol Wagner
Keywords
Ethnicity and Disease, Immune System, Pregnancy, Vitamin D
Summary

The goal of this study is to improve racial equality for all pregnant women and their developing babies. We will study women of diverse racial/ethnic backgrounds who will receive either the current vitamin D standard of 400 IU/day (in the prenatal vitamin) or 4400 IU/day (dose found in previous study to achieve vitamin D sufficiency and optimal 1,25(OH)2D production).

Institution
MUSC
Recruitment Contact
Judith Shary
(843)792-8454
sharyj@musc.edu

A Prospective investigation of DOSS exposure during pregnancy and potential lipophilic alterations in offspring. Save

Date Added
September 21st, 2015
PRO Number
Pro00046776
Researcher
Cecil Nelson
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to look at the how the use of products that contain a certain chemical compound Docusate, commonly referred to as DOSS, may have on pregnant women and their babies. DOSS is used in many commercially available products, such as pesticides, personal care products, and laxatives. This study will focus on DOSS and the use of Colace which is a commonly prescribed stool softener used in pregnancy. This study will involve pregnant women who are being admitted into MUSC?s Labor and Delivery unit.

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

Impact of Dural Puncture Epidural versus Traditional Lumbar Epidural on Onset of Labor Analgesia Save

Date Added
August 18th, 2015
PRO Number
Pro00034219
Researcher
Latha Hebbar
Keywords
Pain, Pregnancy
Summary

Epidural block is the gold standard for labor analgesia. However, the onset of optimal analgesia can take 15-20 minutes. This is because the epidural medication has to cross the duramater to block the pain fibres. Puncturing the duramater and deposting of drugs directly in the cerebrospinal fluid results in a quicker onset of action, but is associated with maternal and fetal sideffects. The current study will make a dural puncture but will not deposit the medication in the cerebrospinal fluid. Instead after the dural puncture, the medication will be placed in the epidural space. However, the theoretical dural puncture will facilitate a quicker onset of action without the maternal and fetal side-effects

Institution
MUSC
Recruitment Contact
Latha Hebbar
843-792-2322
hebbarl@musc.edu

The Contribution of Gut Microbiota to Prenatal Methylmercury Exposure Save

Date Added
August 4th, 2015
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 14th, 2015
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
843.792.6323
yeadon@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

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