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

NCT00343317 | Completed

• 1 other identifier: RES112/02
• Study Type: interventional
• Target: 1,372
• Locations: 1 country
• Sites: 1

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.

Conditions

Puerperal Sepsis

Keywords

puerperal sepsis; HIV infection; prophylactic antibiotics

Outcome Measures

Primary Outcomes (2)

• 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.

Interventions

Intrapartum Cefoxitin (2g) vs. placebo DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of KwaZulu: lead
• Bristol-Myers Squibb: collaborator

Study Sites (1)

University of KwaZulu-Natal / King Edward VIII Hospital

Durban, KwaZulu-Natal, 4013, South Africa

Location

MeSH Terms

Conditions

Puerperal Infection; HIV Infections

Condition Hierarchy (Ancestors)

Pregnancy Complications, Infectious; Infections; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Hannah M Sebitloane, MBChB, FCOG

  University of KwaZulu

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2006
• First Posted: June 22, 2006
• Study Start: February 1, 2003
• Study Completion: May 1, 2005
• Last Updated: June 22, 2006

Record last verified: 2005-05

Locations

ZA (1)