Measuring Adverse Pregnancy and Newborn Congenital Outcomes

Pregnancy Related Clinical Trial

— MANGO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04405700
• Other study ID #: 2002126816
• Status: Recruiting
• Start date: September 29, 2020
• Est. completion date: May 31, 2025

Study information

• Verified date: February 2024
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2800
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• Congenital Disorders
• HIV Infections
• HIV/AIDS
• Newborn Morbidity
• Pregnancy Related

Intervention

Other:
• Pharmacovigilance surveillance program
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).

Locations

Country	Name	City	State
Kenya	Moi Teaching and Referral Hospital	Eldoret

Sponsors (1)

Lead Sponsor	Collaborator
Indiana University

Country where clinical trial is conducted

Kenya, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pregnancy outcomes	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)	At time of delivery
Primary	Infant/birth outcomes	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)	At 1, 6, and 12 months post-delivery