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Completed

NCT Number: NCT01703884

ANC & Malaria Diagnostic 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.

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Key information

Conditions

Malaria Infections Mosquito-Borne Diseases Parasitic Diseases Protozoan Infections Vector Borne Diseases

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Dafra & Do districts

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ASAQ

Drug

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

Primary outcomes

  1. 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

  1. The proportion of women with peripheral positive malaria infection at delivery

    Time frame: 9 months

    The proportion of women with peripheral positive malaria infection at delivery (defined via detection of asexual stages of P. f alciparum by microscopy)

Other outcomes

  1. The proportion of women with severe anaemia in women at delivery

    Time frame: 9 months

    The proportion of women with severe anaemia in women at delivery (severe anaemia defined as Hg <8 g/dL),

  2. Low Birth Weight

    Time frame: 9 months

    Low Birth Weight (defined as <2500g)

  3. Stillbirth

    Time frame: 28 weeks of gestation

    Stillbirth (defined as dead birth after 28 weeks of gestation)

  4. Perinatal and early neonatal deaths

    Time frame: 7 days post delivery

    Perinatal and early neonatal deaths (i.e. death within 7 days of birth)

  5. External/observable birth defects

    Time frame: 9 months

    Presence of external/observable birth defects in neonates identified at birth or as soon as possible thereafter.

  6. Maternal death

    Time frame: 42 days post delivery

    Maternal death (death within 42 days of delivery, regardless of cause)

Sponsors and collaborators

Lead sponsor

Centre Muraz

Other

Collaborators

  • World Health Organization

Registry information

Official study title

Improved Quality of ANC and Diagnostic Services for Malaria in Pregnancy

Acronym: AQUAMOD

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Oct 11, 2012
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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