ANC & Malaria Diagnostic in Pregnancy (AQUAMOD)

Improved Quality of ANC and Diagnostic Services for Malaria in Pregnancy

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.

Study Overview

• Status: Completed
• Conditions: Malaria
• Intervention / Treatment: Drug: ASAQ

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 Type: Interventional
• Enrollment (Actual): 5254
• Phase: Phase 4

Contacts and Locations

Study Locations

• Burkina Faso
  • Hauts Bassins-houet
    • Bobo-Dioulasso, Hauts Bassins-houet, Burkina Faso, 01
      • Dafra & Do districts

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: 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.; Other Names: Coarsucam, ASAQ Winthrop
No Intervention: SP; At ANC and labor wards for women in the control area, there will be no change from routine approaches.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Placental malaria at delivery	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 )	9 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of women with severe anaemia in women at delivery	The proportion of women with severe anaemia in women at delivery (severe anaemia defined as Hg <8 g/dL),	9 months
Low Birth Weight	Low Birth Weight (defined as <2500g)	9 months
Stillbirth	Stillbirth (defined as dead birth after 28 weeks of gestation)	28 weeks of gestation
Perinatal and early neonatal deaths	Perinatal and early neonatal deaths (i.e. death within 7 days of birth)	7 days post delivery
External/observable birth defects	Presence of external/observable birth defects in neonates identified at birth or as soon as possible thereafter.	9 months
Maternal death	Maternal death (death within 42 days of delivery, regardless of cause)	42 days post delivery

Collaborators and Investigators

• Sponsor: Centre Muraz
• Collaborators: World Health Organization
• Investigators: Principal Investigator: Halidou Tinto, PharmD, PhD, centre muraz - irss

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: October 8, 2012
• First Submitted That Met QC Criteria: October 10, 2012
• First Posted (Estimate): October 11, 2012

Study Record Updates

• Last Update Posted (Estimate): July 31, 2015
• Last Update Submitted That Met QC Criteria: July 29, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Keywords: Malria diagnosis; Malaria prevention in pregnancy; ANC services improvement
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: B00531