ANC & Malaria Diagnostic in Pregnancy

NCT ID: NCT01703884

Last Updated: 2015-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 5254 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-12-31

Brief Summary

The program's overall objective is to assess the impact of a package of interventions aimed at reducing malaria-related mortality and morbidity in pregnant women and newborns by ensuring access to a package of interventions designed to optimise the detection and treatment of malaria during pregnancy as well as improving the early detection and treatment of malaria during the third trimester.

Detailed Description

This is a cluster-randomised study in which the health facility is the unit of randomisation. 16 health facilities will be randomised to intervention and control. At the community level women will be encouraged to access ANC early in the pregnancy, attend follow-up antenatal visits throughout the pregnancy and deliver at the facility. The current recommended standard of care will be provided to all women attending antenatal and obstetric care. In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (> 28 weeks of pregnancy), women will be systematically evaluated with selected diagnostic test for whether they have malaria parasites and treated effectively. Skilled birth attendants at the facility will be trained in emergency obstetric and neonatal care and the assessment of neonates for danger signs, low birth weight and external/observable birth defects. In the control area, women will be provided with standard practice of care. In both areas, women will be diagnosed and treated at delivery if they are positive.

Conditions

Malaria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

ASAQ

In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy women will be systematically evaluated with RDT for whether they have malaria parasites and treated effectively.

Group Type: EXPERIMENTAL

ASAQ

Intervention Type: DRUG

In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (\> 28 weeks of pregnancy), women will be systematically evaluated with malaria RDT for whether they have malaria parasites and treated effectively with ASAQ.

SP

At ANC and labor wards for women in the control area, there will be no change from routine approaches.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

ASAQ

In the intervention area, obstetric, medical, drug-exposure histories will be collected at ANC visits. In addition, in the last trimester of the pregnancy (\> 28 weeks of pregnancy), women will be systematically evaluated with malaria RDT for whether they have malaria parasites and treated effectively with ASAQ.

Intervention Type: DRUG

Other Intervention Names

Coarsucam, ASAQ Winthrop

Eligibility Criteria

Inclusion Criteria

• Located in the geographical location of Dafra & Do district
• Have a minimum attendance of 200 pregnant women per year

Exclusion Criteria

• other public health facilities, private clinics and Dafra District Hospital will be excluded from the study.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

World Health Organization

OTHER

Sponsor Role: collaborator

Centre Muraz

OTHER

Sponsor Role: lead

Responsible Party

Tinto Halidou

PharmD, Msc, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Halidou Tinto, PharmD, PhD

Role: PRINCIPAL_INVESTIGATOR

centre muraz - irss

Locations

Dafra & Do districts

Bobo-Dioulasso, Hauts Bassins-houet, Burkina Faso

Countries

Burkina Faso

Other Identifiers

B00531

Identifier Type: -

Identifier Source: org_study_id