Clinical trial NCT01703884: ANC & Malaria Diagnostic in Pregnancy
Official title: Improved Quality of ANC and Diagnostic Services for Malaria in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malaria
Keywords: Malria diagnosis
Malaria prevention in pregnancy
ANC services improvement
Lead sponsor: Centre Muraz
Sponsor class: OTHER
Collaborators: name: World Health Organization
First posted: 2012-10-11
Enrollment: 5254
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Placental malaria at delivery
timeFrame: 9 months
Secondary outcomes:
measure: The proportion of women with peripheral positive malaria infection at delivery
timeFrame: 9 months
Other outcomes:
measure: The proportion of women with severe anaemia in women at delivery
timeFrame: 9 months
measure: Low Birth Weight
timeFrame: 9 months
measure: Stillbirth
timeFrame: 28 weeks of gestation
measure: Perinatal and early neonatal deaths
timeFrame: 7 days post delivery
measure: External/observable birth defects
timeFrame: 9 months
measure: Maternal death
timeFrame: 42 days post delivery
Locations:
city: Bobo-Dioulasso
country: Burkina Faso
facility: Dafra & Do districts
state: Hauts Bassins-houet
Study officials:
affiliation: centre muraz - irss
name: Halidou Tinto, PharmD, PhD
role: PRINCIPAL_INVESTIGATOR
References: