Safe Pregnancy by Infectious Disease Control
July 29, 2014 updated by: NICHD Global Network for Women's and Children's Health
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.
Study Overview
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.
Study Type
Observational
Enrollment (Actual)
2008
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Kinshasa, Congo, The Democratic Republic of the
- Binza Maternity
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Kinshasa, Congo, The Democratic Republic of the
- Kingasani Maternity
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Robin Ryder, M.D., University of North Carolina
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2004
Study Completion (Actual)
March 1, 2005
Study Registration Dates
First Submitted
June 19, 2007
First Submitted That Met QC Criteria
June 19, 2007
First Posted (Estimate)
June 21, 2007
Study Record Updates
Last Update Posted (Estimate)
July 31, 2014
Last Update Submitted That Met QC Criteria
July 29, 2014
Last Verified
July 1, 2014
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GN 02 - Pilot
- U01HD043475 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.