RecruitingNCT04405700

Measuring Adverse Pregnancy and Newborn Congenital Outcomes

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


Sponsor

Indiana University

Enrollment

2,800 participants

Start Date

Sep 29, 2020

Study Type

OBSERVATIONAL

Conditions

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).


Eligibility

Sex: FEMALE

Plain Language Summary

Simplified for easier understanding

This observational study in Kenya follows pregnant women — both those living with HIV and those who are HIV-negative — through pregnancy and delivery to track rates of birth defects, pregnancy complications, and newborn health outcomes. As more HIV-positive women take antiretroviral medications during pregnancy, researchers want to understand how HIV and its treatments may affect the developing baby, and to build better monitoring systems for detecting congenital abnormalities. **You may be eligible if...** - You are pregnant and attending prenatal care at the study clinic - You understand English or Swahili - All infants born to enrolled mothers are automatically included in the study **You may NOT be eligible if...** - You have a physical or mental disability that prevents you from giving informed consent - There are no exclusion criteria for infants born to enrolled women Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

OTHERPharmacovigilance 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(1)

Moi Teaching and Referral Hospital

Eldoret, Kenya

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NCT04405700


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