Safe Pregnancy by Infectious Disease Control
This study has been completed.
Sponsor:
Collaborators:
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
RTI International
University of North Carolina
Kinshasa School of Public Health
Information provided by:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier:
NCT00489619
First received: June 19, 2007
Last updated: August 20, 2007
Last verified: August 2007
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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: | Additional Descriptors: Convenience Sample Primary Purpose: Screening Time Perspective: Cross-Sectional 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 Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD):
| Enrollment: | 2008 |
| Study Start Date: | April 2004 |
| Study Completion Date: | March 2005 |
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
| The Democratic Republic of the Congo | |
| Kingasani Maternity | |
| Kinshasa, The Democratic Republic of the Congo | |
| Binza Maternity | |
| Kinshasa, The Democratic Republic of the Congo | |
Sponsors and Collaborators
Global Network for Women's and Children's Health Research
Bill and Melinda Gates Foundation
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:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00489619 History of Changes |
| Other Study ID Numbers: | GN 02 - Pilot, U01 HD043475 |
| Study First Received: | June 19, 2007 |
| Last Updated: | August 20, 2007 |
| 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) |
Additional relevant MeSH terms:
|
Communicable Diseases Infection Malaria Protozoan Infections Parasitic Diseases |
ClinicalTrials.gov processed this record on June 17, 2013