Schistosomiasis in Women of Reproductive Age in Burkina F... | NCT00463632

Studies
Schistosomiasis in Women of Reproductive Age in Burkina Faso: Implications for Control

NCT00463632

Sponsor

DBL -Institute for Health Research and Development

Status

Completed

Last Update Posted

Jan 12, 2010Estimated

Enrollment

200Estimated

Phase

Not provided

Conditions

Schistosomiasis
Anaemia
Pregnancy

Interventions

Not provided

Countries

Burkina Faso

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

Status Module

Record Verification Date

Jan 2010

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

Jan 2007

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Apr 19, 2007

First Submission Date that Met QC Criteria

Apr 19, 2007

First Posted Date

Apr 20, 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

Jan 11, 2010

Last Update Posted Date

Jan 12, 2010Estimated

Name	Class
Centre Muraz	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

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

Cross-sectional study of prevalence and intensity of schistosome infection in pregnant women, follow-up into postpartum, and the association of schistosome infection with haemoglobin concentration, compared to a group of non-pregnant women.

Detailed Description

The objective of this study is to investigate the epidemiology of schistosomiasis and anaemia among pregnant and non-pregnant women in Burkina Faso and explore the implications for the national schistosomiasis control programme and future studies.

Specific objectives are:

to determine the prevalence and intensity of schistosome infection in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in an area which is hyperendemic for S.haematobium infection and in which there is little or no S.mansoni infection
to determine the prevalence and intensity of schistosome infection in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in an area in which S.mansoni infection is common
to determine Haemoglobin concentration in pregnant women attending for antenatal care and in non-pregnant women of reproductive age in the regions described above
to investigate the association between infection and haemoglobin concentration in pregnant and non-pregnant women
to determine the prevalence of other parasitic infections in pregnant women and non-pregnant women including hookworms, ascaris, trichuris and malaria
to demonstrate the research team's ability to follow-up pregnant women recruited at antenatal care clinics onto the postpartum period

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

Retention

Enrollment

200Estimated

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women attending for ANC
Non-pregnant women age 15-45 years accompanying relatives or children to the health centres or for immunization

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

45 Years

Standard Ages

ChildAdult

Study Population

antenatal care clinics child immunization program

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Seydou Touré, MD	The National Schistosomiasis Control Program Burkina Faso	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Dori Health Centre		Dori			Burkina Faso
National Schistosomiasis Control Program

Condition Browse Module

MeSH Terms

ID	Term
D012552	Schistosomiasis
D000740	Anemia

Ancestor Terms

ID	Term
D014201	Trematode Infections
D006373	Helminthiasis
D010272	Parasitic Diseases
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided