Safe Pregnancy by Infectious Disease Control

NCT ID: NCT00489619

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2008 participants

Study Classification

OBSERVATIONAL

Study Start Date

2004-04-30

Study Completion Date

2005-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pregnancy Malaria

Study Design

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Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Global Network for Women's and Children's Health Research

OTHER

Sponsor Role collaborator

Bill and Melinda Gates Foundation

OTHER

Sponsor Role collaborator

Fogarty International Center of the National Institute of Health

NIH

Sponsor Role collaborator

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

RTI International

OTHER

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

Kinshasa School of Public Health

OTHER

Sponsor Role collaborator

NICHD Global Network for Women's and Children's Health

NETWORK

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Robin Ryder, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina

Locations

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Binza Maternity

Kinshasa, , Democratic Republic of the Congo

Site Status

Kingasani Maternity

Kinshasa, , Democratic Republic of the Congo

Site Status

Countries

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Democratic Republic of the Congo

Related Links

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http://gn.rti.org

Global Network for Women's and Children's Health Research

http://www.rti.org

Research Triangle Institute International

Other Identifiers

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U01HD043475

Identifier Type: NIH

Identifier Source: secondary_id

View Link

GN 02 - Pilot

Identifier Type: -

Identifier Source: org_study_id

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