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Safe Pregnancy by Infectious Disease Control

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00489619
First Posted: June 21, 2007
Last Update Posted: July 31, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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 Integrative Health (NCCIH)
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 (Responsible Party):
NICHD Global Network for Women's and Children's Health
  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

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Safe Pregnancy by Infectious Disease Control in the Democratic Republic of Congo - Pilot Study

Resource links provided by NLM:


Further study details as provided by NICHD Global Network for Women's and Children's Health:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00489619


Locations
Congo, The Democratic Republic of the
Binza Maternity
Kinshasa, Congo, The Democratic Republic of the
Kingasani Maternity
Kinshasa, Congo, The Democratic Republic of the
Sponsors and Collaborators
NICHD Global Network for Women's and Children's Health
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 Integrative Health (NCCIH)
National Institute of Dental and Craniofacial Research (NIDCR)
National Cancer Institute (NCI)
RTI International
University of North Carolina
Kinshasa School of Public Health
Investigators
Principal Investigator: Robin Ryder, M.D. University of North Carolina
  More Information

Additional Information:
Responsible Party: NICHD Global Network for Women's and Children's Health
ClinicalTrials.gov Identifier: NCT00489619     History of Changes
Other Study ID Numbers: GN 02 - Pilot
U01HD043475 ( U.S. NIH Grant/Contract )
First Submitted: June 19, 2007
First Posted: June 21, 2007
Last Update Posted: July 31, 2014
Last Verified: July 2014

Keywords provided by NICHD Global Network for Women's and Children's Health:
Infectious diseases
Democratic Republic of Congo
Malaria
International
Maternal and child health
Women's Health
Global Network
Sexually transmitted infections (STIs)

Additional relevant MeSH terms:
Malaria
Communicable Diseases
Infection
Protozoan Infections
Parasitic Diseases