ANC & Malaria Diagnostic in Pregnancy

Malaria Clinical Trial

— AQUAMOD  

Official title:

Improved Quality of ANC and Diagnostic Services for Malaria in Pregnancy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01703884
• Other study ID #: B00531
• Status: Completed
• Phase: Phase 4
• First received: October 8, 2012
• Last updated: July 29, 2015
• Start date: August 2012
• Est. completion date: December 2014

Study information

• Verified date: July 2015
• Source: Centre Muraz
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Nations: World Health Organization
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5254
• Est. completion date: December 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Malaria

Intervention

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.

Locations

Country	Name	City	State
Burkina Faso	Dafra & Do districts	Bobo-Dioulasso	Hauts Bassins-houet

Sponsors (2)

Lead Sponsor	Collaborator
Centre Muraz	World Health Organization

Country where clinical trial is conducted

Burkina Faso, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	No
Other	Low Birth Weight	Low Birth Weight (defined as <2500g)	9 months	No
Other	Stillbirth	Stillbirth (defined as dead birth after 28 weeks of gestation)	28 weeks of gestation	No
Other	Perinatal and early neonatal deaths	Perinatal and early neonatal deaths (i.e. death within 7 days of birth)	7 days post delivery	No
Other	External/observable birth defects	Presence of external/observable birth defects in neonates identified at birth or as soon as possible thereafter.	9 months	No
Other	Maternal death	Maternal death (death within 42 days of delivery, regardless of cause)	42 days post delivery	No
Primary	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	No
Secondary	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	No