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Measuring Adverse Pregnancy and Newborn Congenital Outcomes

RecruitingN/A

Sponsor: Indiana University

Conditions: HIV/AIDS, Pregnancy Related, Congenital Disorders, Newborn Morbidity

Interventions: Pharmacovigilance surveillance program

Countries: Kenya

The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).

Eligibility overview

Sex: FEMALE

Healthy volunteers: Yes

Study type: OBSERVATIONAL

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)

Locations (1)

Eldoret, Kenya