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Completed

NCT Number: NCT00489619

Safe Pregnancy by Infectious Disease Control

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.

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Key information

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Binza Maternity, Kinshasa, Democratic Republic of the Congo

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

NICHD Global Network for Women's and Children's Health

Network

Collaborators

  • Bill and Melinda Gates Foundation
  • Fogarty International Center of the National Institute of Health
  • Global Network for Women's and Children's Health Research
  • Kinshasa School of Public Health
  • National Cancer Institute (NCI)
  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institute of Dental and Craniofacial Research (NIDCR)
  • RTI International
  • University of North Carolina

Registry information

Official study title

Safe Pregnancy by Infectious Disease Control in the Democratic Republic of Congo - Pilot Study

Important dates

Study start
2004
Study completion
2005
First posted
Jun 21, 2007
Registry last updated
Jul 31, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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