Completed

A Study to Collect Information About HIV-Positive Pregnant Women and Their Babies

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What is being collected

Data Collection

Collected from today forward - Prospective
Who is being recruted

HIV Infections

+ Pregnancy
How is the trial designed

Other

Observational

Summary

Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 7, 2013
Sourced from a government-validated database.Claim as a partner

The purpose of this study is to collect medical information about HIV-positive pregnant women and their babies who have been (or are being) seen at study sites. This information will be used to help design future research studies for these patients. The population of HIV-positive pregnant women and their babies who are seen at study sites has not been officially examined. In order to design future studies to research the best care for these patients, this study will examine important characteristics and the general number of women in these trials. The population served at affiliated ACTG sites has not been officially described. Anecdotal evidence, however, has surfaced regarding the characteristics of HIV-infected pregnant women and the current standard of care during pregnancy. This chart abstraction study is designed to define, more accurately, the pertinent characteristics and general numbers of women in these trials. In this medical chart abstraction study, pertinent information is collected on all HIV-infected pregnant women and their infants who receive primary or consultative care at PACTG 367 study sites. Part A profiles all HIV-infected women who received care or consultation at study sites and who had a pregnancy outcome between January 1, 1998 through July 1, 1998. \[AS PER AMENDMENT 04/12/02: Part A is closed to enrollment.\] Part B profiles HIV-infected pregnant women who receive primary or consultative care and a pregnancy outcome following July 1, 1998.

Official TitleMedical Chart Abstraction of HIV-Infected Pregnant Women and Their Infants Receiving Care or Consultation at Study Sites 
Principal SponsorNational Institute of Allergy and Infectious Diseases (NIAID)
Last updated: October 7, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
2000 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.

How information is collected
Researchers start collecting data from the present day forward, following participants over time to observe outcomes. This approach helps identify how exposures or behaviors may lead to health events in the future.Other Ways to Collect Data
Retrospective
: These studies use existing medical records or past data.

Cross-sectional
: These studies collect data at one single point in time.

Others
: Some studies use a mix of approaches or less common designs depending on the research goal.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
FemaleBiological sex of participants that are eligible to enroll.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
HIV Infections
Pregnancy
Criteria

Inclusion Criteria A patient may be eligible for this study if she: * Is an HIV-positive woman. * Is receiving care at a study site during the study period or her infant is receiving care at a study site and whose delivery information is available. * Had a baby on or after January 1, 1998.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has 2 locations
Suspended
Brigham and Women's Hosp., Div. of Infectious DiseaseBoston, United StatesSee the location
Suspended
Rutgers - New Jersey Medical School CRSNewark, United States

Completed2 Study Centers