Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women

• Status: Completed
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: Female

Summary

Postpartum infections are among the leading causes of maternal mortality world-wide, particularly in under-resourced countries. Available data suggests that HIV infected women are at greater risk of postpartum complications than uninfected women. In South Africa, HIV/AIDS and related infections are now cumulatively the leading causes of maternal deaths (though indirectly), with puerperal sepsis among the 5 most common causes.

This was a prospective longitudinal cohort of HIV infected (n = 675) and uninfected (n = 648) women. These were women in whom vaginal delivery was anticipated, and were recruited at > 36 weeks of gestation during the antenatal period.

Hypothesis - HIV infected women are at increased risk of postpartum infectious morbidity and this morbidity can be reduced by use of prophylactic intrapartum antibiotics.

• Phase: N/A
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of KwaZulu
• Collaborator: Bristol-Myers Squibb
• Treatments: Anti-Bacterial Agents; Antibiotics, Antitubercular; Cefoxitin

Criteria

Inclusion Criteria:

• Women with a pregnancy of > to 36 weeks of gestation

• Women with known HIV status as documented by routine rapid HIV tests, following pre-test voluntary counselling and testing (VCT).

• Women who gave informed study consent.

• Over the age of 18years

• Eligible for vaginal delivery

Exclusion Criteria:

• Women who received antibiotic therapy less than 2 weeks prior to study enrolment.

• Women planned for elective caesarean delivery.

• Obstetric complications such as preterm prelabour rupture of membranes, cardiac disease, diabetes and antepartum haemorrhage.