Skip to main content
Clinical Trials/NCT01703884
NCT01703884
Completed
Phase 4

Improved Quality of ANC and Diagnostic Services for Malaria in Pregnancy

Centre Muraz1 site in 1 country5,254 target enrollmentAugust 2012
ConditionsMalaria
InterventionsASAQ
DrugsASAQ

Overview

Phase
Phase 4
Intervention
ASAQ
Conditions
Malaria
Sponsor
Centre Muraz
Enrollment
5254
Locations
1
Primary Endpoint
Placental malaria at delivery
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2012
End Date
December 2014
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Tinto Halidou

PharmD, Msc, PhD

Centre Muraz

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.

Arms & 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 women will be systematically evaluated with RDT for whether they have malaria parasites and treated effectively.

Intervention: ASAQ

Outcomes

Primary Outcomes

Placental malaria at delivery

Time Frame: 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 Outcomes

  • The proportion of women with peripheral positive malaria infection at delivery(9 months)

Study Sites (1)

Loading locations...

Similar Trials