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NCT00489619 Clinical Trial

Safe Pregnancy by Infectious Disease Control

Pregnancy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00489619
Other study ID # GN 02 - Pilot
Secondary ID U01HD043475
Status Completed
Phase N/A
First received June 19, 2007
Last updated July 29, 2014
Start date April 2004
Est. completion date March 2005

Study information
Verified date July 2014
Source NICHD Global Network for Women's and Children's Health
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 2008
Est. completion date March 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 15 Years and older
Eligibility 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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Congo, The Democratic Republic o Binza Maternity Kinshasa
Congo, The Democratic Republic o Kingasani Maternity Kinshasa

Sponsors (10)
Lead Sponsor Collaborator
NICHD Global Network for Women's and Children's Health Bill and Melinda Gates Foundation, Global Network for Women's and Children's Health Research, John E. Fogarty International Center (FIC), 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

Country where clinical trial is conducted

Congo, The Democratic Republic of the, 

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