PregnancyNCT00489619
Safe Pregnancy by Infectious Disease Control
An observational study of Pregnancy and Malaria, run by NICHD Global Network for Women's and Children's Health at 2 sites in Democratic Republic of the Congo.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women onlyHealthy volunteers can take part
- How many people
- 2,008 participants
- Where
- 2 sitesDemocratic Republic of the Congo
- Study dates
- Apr 2004to Mar 2005
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- refusal to participate in the HIV voluntary and counseling program at the maternity center or refusal to share HIV results with the study staff.
Trial locations and contacts
2 sites in 1 country.
Democratic Republic of the Congo2 sites
Binza Maternity
Kinshasa
Kingasani Maternity
Kinshasa
About this study
Official title: 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.
Read the 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.
- Keywords
- Infectious diseases, Democratic Republic of Congo, Malaria, International, Maternal and child health, Women's Health, Global Network, Sexually transmitted infections (STIs)
- Medical subject headings
- Malaria, Communicable Diseases, Sexually Transmitted Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startApr 2004
- Study completionMar 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 2,008 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, 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
- Responsible party
- Sponsor
- Investigators
- Robin Ryder, M.D., Principal investigator, University of North Carolina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489619
- Sponsor's protocol ID
- GN 02 - Pilot
- Other IDs
- U01HD043475
- Status last verified
- Jul 2014
- First submitted
- 19 Jun 2007
- Last updated
- 31 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safe Pregnancy by Infectious Disease Control in the Democratic Republic of Congo - Pilot Study
- ClinicalTrials.gov ID
- NCT00489619
- Acronym / sponsor ID
- GN 02 - Pilot
- Keywords
- Infectious diseases, Democratic Republic of Congo, Malaria, International, Maternal and child health, Women's Health, Global Network, Sexually transmitted infections (STIs)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,008 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Global Network for Women's and Children's Health Research, Bill and Melinda Gates Foundation, Fogarty International Center of the National Institute of Health, 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
- Study start
- Apr 2004
- Study completion
- Mar 2005 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- refusal to participate in the HIV voluntary and counseling program at the maternity center or refusal to share HIV results with the study staff.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2014.
- Global Network for Women's and Children's Health ResearchLink provided by the sponsor.
- Research Triangle Institute InternationalLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robin Ryder, M.D. principal investigator
University of North Carolina
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Malaria, run by NICHD Global Network for Women's and Children's Health at 2 sites in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2014; AzTrials last refreshed its copy on 31 Oct 2026.