Preventing Health Disparities during Pregnancy through Vitamin D Supplementation + save

Date Added
November 5th, 2013
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

Sofia™ ROM FIA Specimen Procurement Protocol + save

Date Added
August 27th, 2013
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

Fertility, Environmental Contaminants and the Developing Ovarian Follicle + save

Date Added
August 16th, 2013
PRO Number
Pro00015729
Researcher
Louis Guillette
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to look at environmental contaminants (potentially harmful substances that have been released into the environment) and infertility (not being able to get pregnant). This study will collect blood and urine samples as part of the routine IVF procedure. Fluid that is usually discarded from the IVF proceudure will also be collected and patients will be asked to fill out a questionnaire.

Institution
MUSC
Recruitment Contact
Holly Boggan
843-876-1434
bogganhl@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
August 13th, 2013
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

The Identification of Biological Markers of Postpartum Depression + save

Date Added
June 4th, 2013
PRO Number
Pro00011507
Researcher
Constance Guille
Keywords
Depression, Genetics, Hormones, Immune System, Pregnancy, Psychiatry, Women's Health
Summary

Postpartum depression (PPD) is a debilitating mood disorder that occurs in 15-20% of childbearing women. Although several psychosocial risk factors for PPD have been identified, a substantial proportion of the risk for the disorder remains unexplained and biological contributors are unclear. The identification of biological markers in PPD will substantially improve our ability to detect and intervene prior to the onset of the disease, uncover novel disease pathways and ultimately, produce better treatments for patients suffering from PPD. The purpose of the study is to identify biological markers of PPD.

Institution
MUSC
Recruitment Contact
Alison Line
843-792-1158
line@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

A comparison of sterile and non-sterile gloves for the incidence of chorioamnionitis during labor: a randomized, controlled trial + save

Date Added
December 19th, 2011
IRB Number
20638
Researcher
Scott Sullivan
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to determine whether the use of sterile or clean gloves during labor exams affects the rate of chorioamnionitis.

When labor exams are needed, the examiner will either use a sterile or a clean glove. Sterile gloves come from a separate package, and clean gloves come from a box. Both are medical gloves, and both are considered clean and safe to use. During labor, a number of factors will be recorded, such as gestational age, timing of rupture of membranes, number of exams, type of delivery, and rate of infection. At birth, several factors will be recorded from the baby, such as Apgar scores, birthweight, infection rate, and infection work-up.

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

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