Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol

Maternal Events and Pregnancy Outcomes in a Cohort of Human Immunodeficiency Virus-Infected Women Receiving Antiretroviral Therapy in Sub- Saharan Africa

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00639145

Acronym

MEPProject

Enrollment

600

Registered

2008-03-20

Start date

2010-09-30

Completion date

2012-12-31

Last updated

2021-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infections, HIV Positive, Pregnant Women

Keywords

HIV, Pregnancy, Antiretrovirals, HIV Seronegativity, Treatment Experienced

Brief summary

The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated by HIV-positive pregnant women and their infants in South Africa and Zambia.

Detailed description

Although the use of HAART in pregnancy has significantly reduced rates of vertical transmission of HIV-1, some questions remain regarding the safety of these therapies and their potential impact on the uninfected infant. The overall goal of the project is to establish a voluntary exposure-registry and perform observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral products during the prenatal period, in order to evaluate the outcome of the pregnancy and safety of the products in HIV-positive pregnant women, and their infants.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

15 Years to 45 Years

Healthy volunteers

Inclusion criteria

* HIV positive pregnant woman on antiretroviral treatment * Able and willing to participate and provide informed consent * Be at least 18 years of age or older than legal age to provide consent * If under legal age, must have legal guardian who is able to give consent * Be an emancipated minor

Exclusion criteria

* History of mental illness * History of condition that would preclude provision of consent * Inability to provide consent

Design outcomes

Primary

Measure	Time frame	Description
Number of Congenital birth defects	At birth	Number of congenital birth defects among infants born in the study

Secondary

Measure	Time frame	Description
Adverse Pregnancy outcomes	At outcome of pregnancy	Pregnancy outcomes other than normal live birth such as preterm birth, stillbirth and low birth weight

Countries

South Africa, Zambia

Outcome results