NCT00489619CompletedNot Applicable
Safe Pregnancy by Infectious Disease Control in the Democratic Republic of Congo - Pilot Study
NICHD Global Network for Women's and Children's Health2 sites in 1 country2,008 target enrollmentStarted: April 2004Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 2,008
- Locations
- 2
Study Overview
Brief Summary
Malaria and sexually transmitted infections (STIs) are common in pregnant women in Africa and are important preventable causes of poor birth outcomes and maternal and infant mortality. This study investigated baseline characteristics of the population including: rates of STIs including HIV, prevalence of malaria and tuberculosis (TB) and resistance to common antimalarial drugs.
Detailed Description
A cross-sectional observational study was conducted with 2008 pregnant women attending either Binza or Kingasani Maternity clinics in Kinshasa, DRC to determine baseline rates of STIs, TB and malaria. Data was collected for sample size calculation in a larger STI/Malaria and TB randomized controlled trial.
Study Design
- Study Type
- Observational
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •older than or equal to 15 years of age
- •presenting for antenatal care at one of the two target maternities for the first time during the current pregnancy
- •willing to provide informed consent
Exclusion Criteria
- •refusal to participate in the HIV voluntary and counseling program at the maternity center or refusal to share HIV results with the study staff.
Investigators
Study Sites (2)
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