ANC & Malaria Diagnostic in Pregnancy (AQUAMOD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2012 by Centre Muraz
Sponsor:
Collaborator:
World Health Organization
Information provided by (Responsible Party):
Tinto Halidou, Centre Muraz
ClinicalTrials.gov Identifier:
NCT01703884
First received: October 8, 2012
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Malaria
Drug: ASAQ
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Improved Quality of ANC and Diagnostic Services for Malaria in Pregnancy

Resource links provided by NLM:


Further study details as provided by Centre Muraz:

Primary Outcome Measures:
  • Placental malaria at delivery [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The proportion of women with peripheral positive malaria infection at delivery (defined via detection of asexual stages of P. f alciparum by microscopy)


Other Outcome Measures:
  • The proportion of women with severe anaemia in women at delivery [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    The proportion of women with severe anaemia in women at delivery (severe anaemia defined as Hg <8 g/dL),

  • Low Birth Weight [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Low Birth Weight (defined as <2500g)

  • Stillbirth [ Time Frame: 28 weeks of gestation ] [ Designated as safety issue: No ]
    Stillbirth (defined as dead birth after 28 weeks of gestation)

  • Perinatal and early neonatal deaths [ Time Frame: 7 days post delivery ] [ Designated as safety issue: No ]
    Perinatal and early neonatal deaths (i.e. death within 7 days of birth)

  • External/observable birth defects [ Time Frame: 9 months ] [ Designated as safety issue: No ]
    Presence of external/observable birth defects in neonates identified at birth or as soon as possible thereafter.

  • Maternal death [ Time Frame: 42 days post delivery ] [ Designated as safety issue: No ]
    Maternal death (death within 42 days of delivery, regardless of cause)


Estimated Enrollment: 7200
Study Start Date: August 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 (> 28 weeks of pregnancy), women will be systematically evaluated with RDT for whether they have malaria parasites and treated effectively. all malaria cases diagnosed in the 2nd and 3rd trimester in the intervention area will be treated with Amodiaquine + Artesunate (ASAQ)
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 Name: 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. However, in case of malaria suspicion, a RDT detecting circulating P. falciparum antigens (SD Bioline) will be performed, if this is determined to be the most effective RDT (on the basis of current data and literature). If positive, the woman will be treated. Treatment will consist on a full course of quinine (24 mg/kg/day for 7 days) as it is done routinely.

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.

  Eligibility

Ages Eligible for Study:   16 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01703884

Contacts
Contact: Halidou Tinto, PharmD, PhD 70346354 ext 226 tintohalidou@yahoo.fr
Contact: Innocent Valea, PharmD, Msc 70138271 ext 226 innocentvalea@yahoo.fr

Locations
Burkina Faso
Dafra & Do districts Recruiting
Bobo-Dioulasso, Hauts Bassins-houet, Burkina Faso, 01
Contact: Kpoda Hervé, MD, Msc    70304088 ext 226    kpodaherve@yahoo.fr   
Sub-Investigator: Kpoda hervé, MD, Msc         
Sponsors and Collaborators
Centre Muraz
World Health Organization
Investigators
Principal Investigator: Halidou Tinto, PharmD, PhD centre muraz - irss
  More Information

No publications provided

Responsible Party: Tinto Halidou, PharmD, Msc, PhD, Centre Muraz
ClinicalTrials.gov Identifier: NCT01703884     History of Changes
Other Study ID Numbers: B00531
Study First Received: October 8, 2012
Last Updated: October 10, 2012
Health Authority: Switzerland: World Health Organization / Tropical Disease Research (WHO/TDR)

Keywords provided by Centre Muraz:
Malria diagnosis
Malaria prevention in pregnancy
ANC services improvement

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases

ClinicalTrials.gov processed this record on August 26, 2014