Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women

This study has been completed.
Sponsor:
Collaborator:
Bristol-Myers Squibb
Information provided by:
University of KwaZulu
ClinicalTrials.gov Identifier:
NCT00343317
First received: June 21, 2006
Last updated: NA
Last verified: May 2005
History: No changes posted
  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

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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
HIV Infections
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on October 19, 2014