Status:
COMPLETED
Prophylactic Intrapartum Antibiotics and Immunological Markers for Postpartum Morbidity in HIV Positive Women
Lead Sponsor:
University of KwaZulu
Collaborating Sponsors:
Bristol-Myers Squibb
Conditions:
Puerperal Sepsis
Eligibility:
FEMALE
18+ years
Phase:
NA
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 p...
Detailed Description
INTRODUCTION The World Health Organisation (WHO) estimates that 582 000 women die world-wide each year due to pregnancy related conditions that could be prevented. Most of these deaths occur in develo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2003
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
1372 Patients enrolled
Trial Details
Trial ID
NCT00343317
Start Date
February 1 2003
End Date
May 1 2005
Last Update
June 22 2006
Active Locations (1)
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1
University of KwaZulu-Natal / King Edward VIII Hospital
Durban, KwaZulu-Natal, South Africa, 4013