Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women - Full Text View

Sponsor:	University of KwaZulu
Collaborator:	Bristol-Myers Squibb
Information provided by:	University of KwaZulu
ClinicalTrials.gov Identifier:	NCT00343317

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:	Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women

Resource links provided by NLM:

MedlinePlus related topics: AIDS Antibiotics Postpartum Care Sepsis

Drug Information available for: Cefoxitin sodium Cefoxitin

U.S. FDA Resources

Further study details as provided by University of KwaZulu:

Primary Outcome Measures:

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

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00343317

Locations

South Africa, KwaZulu-Natal
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

No publications provided

Study ID Numbers:	RES112/02
Study First Received:	June 21, 2006
Last Updated:	June 21, 2006
ClinicalTrials.gov Identifier:	NCT00343317 History of Changes
Health Authority:	South Africa: Medicines Control Council

Keywords provided by University of KwaZulu:

puerperal sepsis
HIV infection
prophylactic antibiotics

Additional relevant MeSH terms:

Systemic Inflammatory Response Syndrome
Anti-Infective Agents
Anti-Bacterial Agents
Sepsis
Pathologic Processes

Therapeutic Uses
Infection
Pharmacologic Actions
Inflammation

ClinicalTrials.gov processed this record on November 27, 2009