Safe Pregnancy by Infectious Disease Control | NCT00489619

Studies
Safe Pregnancy by Infectious Disease Control

NCT00489619

Sponsor

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

Status

Completed

Last Update Posted

Jul 31, 2014Estimated

Enrollment

2,008Actual

Phase

Not provided

Conditions

Pregnancy
Malaria

Interventions

Not provided

Countries

Democratic Republic of the Congo

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U01HD043475	U.S. NIH Grant/Contract		View source

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2004

Primary Completion Date

Not provided

Completion Date

Mar 2005Actual

First Submitted Date

Jun 19, 2007

First Submission Date that Met QC Criteria

Jun 19, 2007

First Posted Date

Jun 21, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 29, 2014

Last Update Posted Date

Jul 31, 2014Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Sponsor

Lead Sponsor

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

Collaborators

Name	Class
Global Network for Women's and Children's Health Research	OTHER
Bill and Melinda Gates Foundation	OTHER
Fogarty International Center of the National Institute of Health	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

2,008Actual

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Robin Ryder, M.D.	University of North Carolina	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Binza Maternity		Kinshasa			Democratic Republic of the Congo
Kingasani Maternity

References Module

Citations

Not provided

ID	Term
D008288	Malaria
D003141	Communicable Diseases
D012749	Sexually Transmitted Diseases

ID	Term
D011528	Protozoan Infections
D010272	Parasitic Diseases
D007239	Infections
D000096724	Mosquito-Borne Diseases

Label	URL
Global Network for Women's and Children's Health Research	View source
Research Triangle Institute International	View source