Safe Pregnancy by Infectious Disease Control

This study has been completed.

Sponsors and Collaborators:	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, Democratic Republic of Congo
Information provided by:	Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:	NCT00489619

Purpose

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.

Condition
Pregnancy Malaria

MedlinePlus related topics: Malaria

U.S. FDA Resources

Study Type:	Observational
Study Design:	Screening, Cross-Sectional, Convenience Sample, Prospective Study
Official Title:	Safe Pregnancy by Infectious Disease Control in the Democratic Republic of Congo - Pilot Study

Further study details as provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Enrollment:	2008
Study Start Date:	April 2004
Study Completion Date:	March 2005

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.

Eligibility

Ages Eligible for Study:	15 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00489619

Locations

Congo, The Democratic Republic of the
Kingasani Maternity
Kinshasa, Congo, The Democratic Republic of the
Binza Maternity
Kinshasa, Congo, The Democratic Republic of the

Sponsors and Collaborators

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, Democratic Republic of Congo

Investigators

Principal Investigator:

Robin Ryder, M.D.

University of North Carolina

More Information

Global Network for Women's and Children's Health Research This link exits the ClinicalTrials.gov site

Research Triangle Institute International This link exits the ClinicalTrials.gov site

Study ID Numbers:	GN 02 - Pilot, U01 HD043475
Study First Received:	June 19, 2007
Last Updated:	August 20, 2007
ClinicalTrials.gov Identifier:	NCT00489619
Health Authority:	United States: Federal Government

Keywords provided by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):

Infectious diseases
Democratic Republic of Congo
Malaria
International

Maternal and child health
Women's Health
Global Network
Sexually transmitted infections (STIs)

Study placed in the following topic categories:

Protozoan Infections
Sexually Transmitted Diseases
Parasitic Diseases
Malaria

Additional relevant MeSH terms:

Communicable Diseases
Coccidiosis
Infection

ClinicalTrials.gov processed this record on January 16, 2009