Clinical trial NCT04405700: Measuring Adverse Pregnancy and Newborn Congenital Outcomes
Official title: Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV/AIDS
Pregnancy Related
Congenital Disorders
Newborn Morbidity
Lead sponsor: Indiana University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 2800
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant and postpartum women who are HIV+ and HIV- and their infants.

Brief summary: 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).

Detailed description: In part 1 of this study, the investigators will use a mixed prospective and cross-sectional cohort study design to implement a PV program at two health facilities affiliated with the Academic Model Providing Access to Healthcare (AMPATH) in western Kenya. The investigators will analyze these data to examine any associations between antiretroviral treatment (ART) and (a) pregnancy and (b) infant/birth outcomes. In part 2, the investigators will create standardized protocols and data exchange standards within IeDEA to enable the merging and analysis of multiregional IeDEA PV data. This will include establishing a Data Coordinating Center based at Indiana University (IU) to serve as a hub for collecting, disseminating and archiving data from the study in Kenya as well as data collected through a similar, ongoing study at health facilities in South Africa affiliated with IeDEA. This study will establish a multiregional PV infrastructure within IeDEA that can be further scaled within the broader IeDEA network.

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)

Primary outcomes:
measure: Pregnancy outcomes
timeFrame: At time of delivery
measure: Infant/birth outcomes
timeFrame: At 1, 6, and 12 months post-delivery
Secondary outcomes:
Other outcomes:
Locations:
city: Eldoret
country: Kenya
facility: Moi Teaching and Referral Hospital
Study officials:
References: