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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
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief 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.


Condition or disease Intervention/treatment
Puerperal Sepsis Drug: Intrapartum Cefoxitin (2g) vs. placebo

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1372 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Prevention
Official Title: Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women
Study Start Date : February 2003
Estimated Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Cefoxitin
U.S. FDA Resources

Arms and Interventions


Outcome Measures

Primary Outcome Measures :
  1. The primary outcome measure was the development of postpartum infectious morbidity amongst HIV infected versus HIV uninfected pregnant women.
  2. To determine the efficacy of intrapartum prophylactic antibiotics in reducing postpartum infectious morbidity in HIV infected women.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.
Contacts and Locations

Information from the National Library of Medicine

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


Locations
South Africa
University of KwaZulu-Natal / King Edward VIII Hospital
Durban, KwaZulu-Natal, South Africa, 4013
Sponsors and Collaborators
University of KwaZulu
Bristol-Myers Squibb
Investigators
Principal Investigator: Hannah M Sebitloane, MBChB, FCOG University of KwaZulu
More Information

ClinicalTrials.gov Identifier: NCT00343317     History of Changes
Other Study ID Numbers: RES112/02
First Posted: June 22, 2006    Key Record Dates
Last Update Posted: June 22, 2006
Last Verified: May 2005

Keywords provided by University of KwaZulu:
puerperal sepsis
HIV infection
prophylactic antibiotics

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Anti-Bacterial Agents
Cefoxitin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents