Measuring Adverse Pregnancy and Newborn Congenital Outcomes

Launched by INDIANA UNIVERSITY · May 22, 2020

Keywords

ClinConnect Summary

This clinical trial is focused on understanding how pregnancy and newborn outcomes, such as congenital abnormalities (birth defects), are affected in both HIV-positive and HIV-negative women. The study aims to create a program that monitors these outcomes at specific healthcare sites. By enrolling women who are pregnant and receiving care at these sites, the researchers hope to gather important information about the health of mothers and their babies.

To participate in this study, women must be pregnant and enrolled in antenatal care (ANC) at the site, and they should be able to understand English or Swahili. Any infants born to these women will also be included in the study, regardless of their gestational age. Participants can expect to share their health information, and in some cases, photos or videos may be taken to assess any potential birth defects. This research will help improve our understanding of how HIV and other factors influence pregnancy outcomes, ultimately aiming to enhance care for mothers and infants.

Gender

FEMALE

Eligibility criteria

• C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:
• • Inclusion criteria for women
• • 1. Pregnant and enrolled in ANC at the study site;
• • 2. Understands English or Swahili.
• • Exclusion criteria for women a. Any physical or mental disability that prevents the woman from providing informed consent
• • Inclusion criteria for infants
• • a. All infants at any gestational age who are born to enrolled women will be included Exclusion criteria for infants (none)
• C2. Data collection for all deliveries at the site:
• • Inclusion criteria for women a. Woman delivers at the site and the delivery is registered at the site
• • Exclusion criteria for women (none)
• • Inclusion criteria for live/stillborn infants
• • a. Infant is delivered at the site and results in the infant/stillbirth being registered at the site
• • Exclusion criteria for infants (none)
• C3. Photos/videos of infants with CAs:
• • Inclusion criteria for infants
• • 1. The infant is live or stillborn at ≥ 24 weeks estimated gestational age
• • 2. The infant has a suspected CA on surface exam
• • Exclusion criteria for infants (none)