Measuring Adverse Pregnancy and Newborn Congenital Outcomes (MANGO)

Indiana University

Status: Enrolling

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

Treatments: Other: Pharmacovigilance surveillance program

Study type: Observational

Funder types: Other

Identifiers

NCT04405700

2002126816

Details and patient eligibility

About

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).

Full 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.

Enrollment: 2,800 estimated patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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)

Trial design

2,800 participants in 3 patient groups

Cohort 1 (C1)

Description:

Prospective recruitment of pregnant women enrolling in antenatal clinic (ANC) at the site. All HIV+ pregnant women and a 1:1 systematic sample of HIV- pregnant women enrolling in ANC at the site will be prospectively enrolled. In addition, medical record data for the mother and infant will be collected at the time of delivery for all women who deliver at the site and as such will contribute to a subset of C2 (below). Women enrolled in C1 who do not deliver at the site will be contacted by phone and through field follow-up to ascertain their pregnancy and infant outcomes. Infants born to women enrolled in this component who are suspected of having congenital abnormalities (CAs) will be enrolled as outlined in C3 (below) if their mothers deliver at the site. If their mothers do not deliver at the site these infants will be enrolled in the field. Photos/videos of infants with CAs will also be taken for review and classification by a panel of experts (see C3 below).

Treatment:

Other: Pharmacovigilance surveillance program

Cohort 2 (C2)

Description:

Cross-sectional data collection for deliveries at the site. Data will be collected retrospectively from medical records for all women who deliver at the site (including the women enrolled in C1 above), as well from the medical records of all newborn infants and stillbirths delivered at the site. Missing or incomplete information in the woman or her infant's medical record will be clarified by contacting the woman to provide this information.

Treatment:

Other: Pharmacovigilance surveillance program

Cohort 3 (C3)

Description:

Photos/videos of infants with CAs. All newborn infants and stillbirths ≥ 24 weeks gestational age delivered at the site, as well as all infants born to women enrolled in C1, will be assessed by surface exam for the presence of CAs. Video and photographs will be taken of CAs identified on surface exam. These images will be reviewed and classified by panel of experts in genetics, dysmorphology and teratology. Mothers of infants with major CAs will be contacted by phone at 1, 6, and 12 months post-delivery to ascertain their infants' vital status and care engagement status.

Treatment:

Other: Pharmacovigilance surveillance program