Recruiting

NCT Number: NCT04405700

Measuring Adverse Pregnancy and Newborn Congenital Outcomes

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).

Recruiting

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Key information

Conditions

HIV/AIDS Acquired Immunodeficiency Syndrome Blood-Borne Infections Communicable Diseases Congenital Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genital Diseases HIV Infections Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Newborn Morbidity Pregnancy Related RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Moi Teaching and Referral Hospital

Eldoret, 30100, Kenya

Location status: Recruiting

Location contact

Edwin O Were, MBChB, MMed

CONTACT

[email protected]

+254722288653

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:

Inclusion criteria

for women

Pregnant and enrolled in ANC at the study site;
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

The infant is live or stillborn at ≥ 24 weeks estimated gestational age
The infant has a suspected CA on surface exam

Exclusion criteria

for infants (none)

Treatment and study plan

Pharmacovigilance surveillance program

Other

The pharmacovigilance (PV) surveillance program will prospectively monitor for 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).

Primary outcomes

Pregnancy outcomes

Time frame: At time of delivery

Live Birth, Still Birth, Miscarriage, Termination of pregnancy, Ectopic Pregnancy, Molar Pregnancy, Not Pregnant, Other); also including pre-term delivery (<37 weeks gestational age) or very pre-term delivery (<32 weeks gestational age)
Infant/birth outcomes

Time frame: At 1, 6, and 12 months post-delivery

Congenital abnormalities on newborn surface exam (e.g., extra digit, hydrocephalus, skull defects, eyes, face, mouth/lip/palate, chest, abdomen, anus, limbs, spine (including neural tube defects), hips, genitalia, skin, etc.); also including low birth weight, small for gestational age (<10th percentile) or very small for gestational age (<3rd percentile)

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Registry information

Official study title

Measuring Adverse Pregnancy and Newborn Congenital Outcomes: An IeDEA Collaboration Study

Acronym: MANGO

Important dates

Study start: 2020
Primary completion: 2026
Study completion: 2026
First posted: May 28, 2020
Registry last updated: Aug 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed