ANC & Malaria Diagnostic in Pregnancy (AQUAMOD)

Muraz Center

Status and phase: Completed; Phase 4

Conditions: Malaria

Treatments: Drug: ASAQ

Study type: Interventional

Funder types: Other

Identifiers

NCT01703884

B00531

Details and patient eligibility

About

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.

Full 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.

Enrollment: 5,254 patients

Sex: Female

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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5,254 participants in 2 patient groups

ASAQ

Experimental group

Description:

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.

Treatment:

Drug: ASAQ

SP

No Intervention group

Description:

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