Detection of Intrauterine Growth Restriction Among Uncomplicated Pregnancy with Additional Ultrasounds in the Third Trimester: A Pilot Randomized Trial At 3 Centers. + save

Date Added
October 22nd, 2012
PRO Number
Pro00017317
Researcher
Eugene Chang
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The objective of this study is to assess 1) how many women with non-complicated singleton pregnancies need to be screened to enroll one patient in the trial, 2) how many sonographic (ultrasound) examinations are done in the group which get routine care, 3) the number of women who complete the study, 4) the likelihood of detecting IUGR in both arm of the trial, 5) the mother and newborns outcomes in each arms of the study.

Institution
MUSC
Recruitment Contact
Natalie Champy
843-792-7525
champyn@musc.edu

The Influence of Trust in the Health Care System on Postpartum Contraceptive Choice + save

Date Added
October 13th, 2012
PRO Number
Pro00012660
Researcher
Angela Dempsey-fanning
Keywords
Pregnancy, Women's Health
Summary

The purpose of this research is to understand the relationship between trust in the health care system and choice of contraception during the postpartum period among pregnant women receiving prenatal care.

Research subjects will complete a questionnaire at enrollment and between delivery and within 5 days of hospital discharge.

A chart review will also be completed to gather use of a birth control method at the six week postpartum vist as well as pertinent medical diagnoses and recroded data such as height, weight, body mass index, and contraceptive plan as documented in the postpartum medical chart.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843-792-6323
yeadon@musc.edu

Proteomic Assessment of Preterm Risk (PAPR). + save

Date Added
October 9th, 2012
PRO Number
Pro00012552
Researcher
Scott Sullivan
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to develop a test for the prediction of preterm delivery. Preterm delivery is defined as birth of a baby before the 37th week of pregnancy. Data regarding risk factors for preterm birth will be assessed by maternal interview. In addition, relevant information regarding neonatal outcomes will be gathered through review of medical records. Finally, a blood sample for proteomic analysis will be obtained.

Institution
MUSC
Recruitment Contact
Kenreka Yeadon-Osaboma
843-792-6323
yeadon@musc.edu

Fertility, Environmental Contaminants and the Developing Ovarian Follicle + save

Date Added
September 4th, 2012
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

Comparison of Aneuploidy Risk Evaluations (CARE): Performance of the Verinata Health Prenatal Aneuploidy Test Compared to Current Fetal Aneuploidy Screening Results and Pregnancy Outcomes in an ‘All‐Risk’ Population. + save

Date Added
July 10th, 2012
PRO Number
Pro00018235
Researcher
Eugene Chang
Keywords
Pregnancy, Women's Health
Summary

The purpose of this research is to determine how well a prenatal blood test developed by Verinata Health, Inc. performs compared to current prenatal screening tests in detecting certain abnormalities in a developing fetus.

Institution
MUSC
Recruitment Contact
Betty Oswald
oswaldbw@musc.edu
843-792-0347

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
Laura Houston
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
Kenreka Yeadon-Osaboma
843-792-6323
yeadon@musc.edu

Investigating Differences in Twin and Triplet Growth + save

Date Added
December 19th, 2011
IRB Number
19215
Researcher
Roger Newman
Keywords
Obstetrics and Gynecology, Pregnancy, Women's Health
Summary

The purpose of this study is to compare the growth between twins and triplets before birth to differences in body size at birth.

If you agree to be in this study the following will happen:

Within fourteen days after birth, your baby will have its body composition (body fat percentage) measured using the PEAPOD device. Infants that are medically unstable will not have a PEAPOD assessment. The PEAPOD will be done at the Children’s Hospital.

(1) The physician or nurse will first take your baby’s weight, length, and head circumference using standard methods.
(2) Next your baby will have baby oil placed on their head and then will be placed in the chamber of the PEAPOD to measure your baby’s volume. The instrument is very sensitive to hair movement and body movement and is why the baby oil is applied.
(3) When the PEAPOD door is closed, comfortable, warm air will flow continuously into the test chamber. We will make sure the baby is comfortable and quiet during the prcedure. Body volume measurements are taken twice and takes about 60 seconds each. The baby can be observed through a window on the PEAPOD while the procedure is being performed. You can be present when the procedure is being performed. The measurements are taken within a 7 to 10 minute time period.
(4) Should the baby become fussy or shows distress, the PEAPOD can be stopped, the door opened and the baby can be accessed and held to comfort or feed. The procedure can be restarted when the baby is comfortable again. You may refuse to have the PEAPOD test restarted.

You will be asked to complete a survey about your nutrition during pregnancy. The survey will ask you about your eating habits. Please try to be as complete as you can when filling out the survey. The survey will be given to you in the hospital, prior to discharge, either at the time of study enrollment or during your hospital admission. You can choose to complete the survey while you are in the hospital or you can take the survey home with you to complete. If you take the survey home with you, a stamped envelope will be given to you so that you may mail the survey back.

Institution
MUSC
Recruitment Contact
JacKetta Cobbs
843-792-3330
cobbsj@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