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.
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.