Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women
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|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|
|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|