Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women
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Purpose
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 | Intervention |
|---|---|
|
Puerperal Sepsis |
Drug: Intrapartum Cefoxitin (2g) vs. placebo |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Prevention |
| Official Title: | Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women |
- 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.
| Estimated Enrollment: | 1372 |
| Study Start Date: | February 2003 |
| Estimated Study Completion Date: | May 2005 |
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations| South Africa | |
| University of KwaZulu-Natal / King Edward VIII Hospital | |
| Durban, KwaZulu-Natal, South Africa, 4013 | |
| Principal Investigator: | Hannah M Sebitloane, MBChB, FCOG | University of KwaZulu |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00343317 History of Changes |
| Other Study ID Numbers: | RES112/02 |
| Study First Received: | June 21, 2006 |
| Last Updated: | June 21, 2006 |
| Health Authority: | South Africa: Medicines Control Council |
Keywords provided by University of KwaZulu:
|
puerperal sepsis HIV infection prophylactic antibiotics |
Additional relevant MeSH terms:
|
HIV Seropositivity Sepsis HIV Infections Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes |
Immune System Diseases Infection Systemic Inflammatory Response Syndrome Inflammation Pathologic Processes Anti-Bacterial Agents Cefoxitin Anti-Infective Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 23, 2013