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Safe Pregnancy by Infectious Disease Control

This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
John E. Fogarty International Center (FIC)
National Center for Complementary and Alternative Medicine (NCCAM)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of North Carolina
Kinshasa School of Public Health
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00489619
First received: June 19, 2007
Last updated: August 20, 2007
Last verified: August 2007
History of Changes

June 19, 2007
August 20, 2007
April 2004
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Complete list of historical versions of study NCT00489619 on ClinicalTrials.gov Archive Site
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Safe Pregnancy by Infectious Disease Control
Safe Pregnancy by Infectious Disease Control in the Democratic Republic of Congo - Pilot Study

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.

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.
Observational
Additional Descriptors: Convenience Sample
Primary Purpose: Screening
Time Perspective: Cross-Sectional
Time Perspective: Prospective
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  • Pregnancy
  • Malaria
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
2008
March 2005
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Inclusion Criteria:

  • older than or equal to 15 years of age
  • pregnant
  • 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.
Female
15 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
The Democratic Republic of the Congo
 
NCT00489619
GN 02 - Pilot, U01 HD043475
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Global Network for Women's and Children's Health Research
  • Bill and Melinda Gates Foundation
  • John E. Fogarty International Center (FIC)
  • National Center for Complementary and Alternative Medicine (NCCAM)
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • National Cancer Institute (NCI)
  • RTI International
  • University of North Carolina
  • Kinshasa School of Public Health
Principal Investigator: Robin Ryder, M.D. University of North Carolina
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
August 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP