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Recruiting NCT04405700

Measuring Adverse Pregnancy and Newborn Congenital Outcomes

— Observational HIV/AIDS Pregnancy Related Congenital Disorders Newborn Morbidity

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pharmacovigilance surveillance program.
Who it may be relevant to
Registry conditions: HIV/AIDS, Pregnancy Related, Congenital Disorders, Newborn Morbidity. Basic parameters: No limits · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Kenya
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

Interventions

  • 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).

Primary outcome measures

  • Pregnancy outcomes [Time frame: At time of delivery]
  • Infant/birth outcomes [Time frame: At 1, 6, and 12 months post-delivery]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

Kenya · 1 center
  • Moi Teaching and Referral Hospital — Eldoret

Identifiers

NCT: NCT04405700 · 2002126816

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗