NCT01703884

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
5,254

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2012

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 11, 2012

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

October 8, 2012

Last Update Submit

July 29, 2015

Conditions

Malaria

Keywords

Malria diagnosisMalaria prevention in pregnancyANC services improvement

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • The proportion of women with peripheral positive malaria infection at delivery

    9 months

Other Outcomes (6)

  • The proportion of women with severe anaemia in women at delivery

    9 months

  • Low Birth Weight

    9 months

  • Stillbirth

    28 weeks of gestation

  • +3 more other outcomes

Study Arms (2)

ASAQ

EXPERIMENTAL

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

SP

NO INTERVENTION

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

Interventions

ASAQDRUG

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.

Also known as: Coarsucam, ASAQ Winthrop
ASAQ

Eligibility Criteria

Age16 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Located in the geographical location of Dafra \& Do district
  • Have a minimum attendance of 200 pregnant women per year

You may not qualify if:

  • other public health facilities, private clinics and Dafra District Hospital will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dafra & Do districts

Bobo-Dioulasso, Hauts Bassins-houet, 01, Burkina Faso

Location

MeSH Terms

Conditions

Malaria

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Study Officials

  • Halidou Tinto, PharmD, PhD

    centre muraz - irss

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD, Msc, PhD

Study Record Dates

First Submitted

October 8, 2012

First Posted

October 11, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2014

Study Completion

December 1, 2014

Last Updated

July 31, 2015

Record last verified: 2015-07

Locations

BU(1)