A Randomized, Placebo-Controlled Study of an Herbal Tea to Support Lactation Save

Date Added
October 28th, 2014
PRO Number
Pro00020353
Researcher
Bernadette Marriott
Keywords
Breastfeeding, Infant, Nutrition, Pregnancy, Women's Health
Summary

The primary purpose of the this study is to evaluate the quality of life of lactating mothers using an all-natural, organic, herbal tea that is currently on the market and has been commercially available for over thirty years in the United States. Compensation is available. Please call the study coordinator for more details.

Institution
MUSC
Recruitment Contact
Carolyn Finch
843-876-5795
weigleca@musc.edu

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

Date Added
August 19th, 2014
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 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

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

A Randomized Controlled Trial of Immediate versus Delayed Insertion of Implanon in Postpartum Adolescents Save

Date Added
October 5th, 2009
IRB Number
19133
Researcher
Angela Dempsey
Keywords
Adolescents, Breastfeeding, Drug Studies, Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

With current standard of care practice, Implanon, a long acting reversible contraceptive measure is placed at the 6 week post partum visit. This study is examining whether or not it is more beneficial to have the Implanon placed prior to leaving the hospital. If you are between 15-21 years of age and are considering using Implanon as your post partum birth control, then you may be eligible to qualify. Study participants have a 50% chance of having Implanon placed prior to leaving the hospital and must commit to completing a baseline questionnaire at enrollment and three follow-up questionnaires by phone at 3,6, and 12 months after delivery. Compensation is available. Please contact the coordinator for more details.

Institution
MUSC
Recruitment Contact
Caitlin Schaffner
843-792-7008
schaffne@musc.edu

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