Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women
|ClinicalTrials.gov Identifier: NCT00343317|
Recruitment Status : Completed
First Posted : June 22, 2006
Last Update Posted : June 22, 2006
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.
|Condition or disease||Intervention/treatment||Phase|
|Puerperal Sepsis||Drug: Intrapartum Cefoxitin (2g) vs. placebo||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||1372 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women|
|Study Start Date :||February 2003|
|Study Completion Date :||May 2005|
- The primary outcome measure was the development of postpartum infectious morbidity amongst HIV infected versus HIV uninfected pregnant women.
- To determine the efficacy of intrapartum prophylactic antibiotics in reducing postpartum infectious morbidity in HIV infected women.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00343317
|University of KwaZulu-Natal / King Edward VIII Hospital|
|Durban, KwaZulu-Natal, South Africa, 4013|
|Principal Investigator:||Hannah M Sebitloane, MBChB, FCOG||University of KwaZulu|