ANC & Malaria Diagnostic in Pregnancy

Phase 4

Completed

• Conditions: Malaria
• Interventions: Drug: ASAQ

• Registration Number: NCT01703884
• Lead Sponsor: Centre Muraz

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-08
• Study First Submitted QC: 2012-10-10
• Study First Posted: 2012-10-11
• Primary Completion: 2014-07
• Study Completion: 2014-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-29
• Last Update Posted: 2015-07-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 5254

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASAQ	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.

Primary Outcome Measures

Name	Time	Method
Placental malaria at delivery	9 months	The main outcome variable of interest will be the proportion of women in each group with placental malaria at delivery (defined as placental biopsies positive for P. falciparum )

Secondary Outcome Measures

Name	Time	Method
The proportion of women with peripheral positive malaria infection at delivery	9 months	The proportion of women with peripheral positive malaria infection at delivery (defined via detection of asexual stages of P. f alciparum by microscopy)

Trial Locations

Locations (1)

Dafra & Do districts; 🇧🇫 Bobo-Dioulasso, Hauts Bassins-houet, Burkina Faso