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ANC & Malaria Diagnostic in Pregnancy (AQUAMOD)

Primary Purpose

Malaria

Status
Completed
Phase
Phase 4
Locations
Burkina Faso
Study Type
Interventional
Intervention
ASAQ
Sponsored by
Centre Muraz
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria focused on measuring Malria diagnosis, Malaria prevention in pregnancy, ANC services improvement

Eligibility Criteria

16 Years - 50 Years (Child, Adult)FemaleDoes not accept 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.

Sites / Locations

  • Dafra & Do districts

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

ASAQ

SP

Arm 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.

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

Outcomes

Primary Outcome Measures

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 )

Secondary Outcome Measures

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)

Full Information

First Posted
October 8, 2012
Last Updated
July 29, 2015
Sponsor
Centre Muraz
Collaborators
World Health Organization
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1. Study Identification

Unique Protocol Identification Number
NCT01703884
Brief Title
ANC & Malaria Diagnostic in Pregnancy
Acronym
AQUAMOD
Official Title
Improved Quality of ANC and Diagnostic Services for Malaria in Pregnancy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre Muraz
Collaborators
World Health Organization

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria
Keywords
Malria diagnosis, Malaria prevention in pregnancy, ANC services improvement

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
5254 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASAQ
Arm Type
Experimental
Arm 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.
Arm Title
SP
Arm Type
No Intervention
Arm Description
At ANC and labor wards for women in the control area, there will be no change from routine approaches.
Intervention Type
Drug
Intervention Name(s)
ASAQ
Other Intervention Name(s)
Coarsucam, ASAQ Winthrop
Intervention 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 (> 28 weeks of pregnancy), women will be systematically evaluated with malaria RDT for whether they have malaria parasites and treated effectively with ASAQ.
Primary Outcome Measure Information:
Title
Placental malaria at delivery
Description
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 )
Time Frame
9 months
Secondary Outcome Measure Information:
Title
The proportion of women with peripheral positive malaria infection at delivery
Description
The proportion of women with peripheral positive malaria infection at delivery (defined via detection of asexual stages of P. f alciparum by microscopy)
Time Frame
9 months
Other Pre-specified Outcome Measures:
Title
The proportion of women with severe anaemia in women at delivery
Description
The proportion of women with severe anaemia in women at delivery (severe anaemia defined as Hg <8 g/dL),
Time Frame
9 months
Title
Low Birth Weight
Description
Low Birth Weight (defined as <2500g)
Time Frame
9 months
Title
Stillbirth
Description
Stillbirth (defined as dead birth after 28 weeks of gestation)
Time Frame
28 weeks of gestation
Title
Perinatal and early neonatal deaths
Description
Perinatal and early neonatal deaths (i.e. death within 7 days of birth)
Time Frame
7 days post delivery
Title
External/observable birth defects
Description
Presence of external/observable birth defects in neonates identified at birth or as soon as possible thereafter.
Time Frame
9 months
Title
Maternal death
Description
Maternal death (death within 42 days of delivery, regardless of cause)
Time Frame
42 days post delivery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halidou Tinto, PharmD, PhD
Organizational Affiliation
centre muraz - irss
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dafra & Do districts
City
Bobo-Dioulasso
State/Province
Hauts Bassins-houet
ZIP/Postal Code
01
Country
Burkina Faso

12. IPD Sharing Statement

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ANC & Malaria Diagnostic in Pregnancy

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