Retrospective and Prospective Data Collection of Maternal, Fetal, and Neonatal Variables from Patients Referred to Fetal Heart Society Participant Centers with a Maternal or Fetal Abnormality Aff ecting the Fetal Cardiovascular System. (Fetal Heart Society Collaborative Research Database Project) FHS Protocol Number 001 Save

Date Added
April 18th, 2016
PRO Number
Pro00054603
Researcher
Carolyn Taylor
Keywords
Children's Health, Pregnancy
Summary

In the past, many patients have been referred to a FHS participant site for evaluation and treatment of maternal or fetal abnormalities. Until recently, most studies regarding maternal or fetal disease have been single-center studies. Many maternal and fetal abnormalities are exceedingly rare. Due to the relative rarity of many forms of fetal congenital malformations, little collective short- and long-term data on outcomes exist. The Fetal Heart Society aims to collect data on a large cohort of patients and improve best clinical practice and improve outcomes for rare diseases.

Institution
MUSC
Recruitment Contact
Kalyan Chundru
843-792-1213
choudhar@musc.edu

A Novel Approach to Reduce Pain, Prescription Opioid Use & Misuse in Pregnancy Save

Date Added
March 1st, 2016
PRO Number
Pro00052361
Researcher
Constance Guille
Keywords
Pain, Pregnancy
Summary

Pregnant women using prescription opioid medication (pain medications) are invited to take part in a program for the reduction of pain and prescription opioid misuse.

Institution
MUSC
Recruitment Contact
Edie Douglas
843-792-0403
douglaed@musc.edu

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

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

Date Added
September 21st, 2015
PRO Number
Pro00046776
Researcher
Demetri Spyropoulos
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 Jenkins
843.792.6992
saundert@musc.edu

Determine the effect of cultured endothelial progenitor cells from normal human cord blood on the protection of mice from cecal ligation puncture -induced sepsis. Save

Date Added
March 19th, 2015
PRO Number
Pro00042294
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to study cells that are found in the cord blood of pregnant women to see if they might be helpful in treating certain types of infections. This type of research is still in the very early stage, so we will do this by taking some of the special cells found in cord blood and injecting them into mice and studying them.

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

Structural Artery Defects at the Utero-placental Unit in Preeclampsia Save

Date Added
January 20th, 2015
PRO Number
Pro00040396
Researcher
Julio Mateus nino
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to learn more about blood vessel defects in the placental bed and in the placenta of women who have pregnancies that are complicated by preeclampsia.

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

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

Date Added
November 18th, 2014
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
Angela Robinson
843-792-6043
robia@musc.edu

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

Date Added
November 4th, 2014
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 might affect outcomes in pregnancy for pregnant women. We are recruiting 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

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

Date Added
April 25th, 2013
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
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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