Community-based scheduled screening and treatment of malaria in pregnancy for improved maternal and infant health

• Register: ISRCTN
• Last refreshed on: 29 April 2019
• Main ID: ISRCTN37259296
• Date of registration: 05/07/2013
• Prospective Registration: Yes
• Primary sponsor: Royal Tropical Institute (KIT)
• Public title: Community-based scheduled screening and treatment of malaria in pregnancy for improved maternal and infant health
• Scientific title: COmmunity-based scheduled Screening and treatment of malaria in pregnancy for Improved maternal and infant health: a cluster-randomized trial in The Gambia, Burkina Faso and Benin
• Date of first enrolment: 01/09/2013
• Target sample size: 5400
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN37259296
• Study type: Interventional
• Study design: Multi-centre cluster randomized trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Benin, Burkina Faso, Gambia

Contacts

• Name: Henk Schallig

Key inclusion & exclusion criteria

Inclusion criteria:
1. Residence in the study area and intention to stay in the area for the duration of the pregnancy and for delivery.
2. Aged at least 16 years (pregnant adolescents younger than 16 years will be considered only if they are accompanied by a responsible adult [in the Gambia] or married [considered an adult by marriage in Burkina Faso and Benin])
3. Willing to provide biological samples as and when required during the study period (blood and placental biopsy)
4. Informed consent

Exclusion criteria:
1. A history of sensitivity to sulphonamides
2. Already participating in another research study


Age minimum:
Age maximum:
Gender: Female

Health Condition(s) or Problem(s) studied

Malaria
Infections and Infestations
Unspecified malaria

Intervention(s)

A two-armed cluster randomised controlled trial in which communities/villages will be randomised to receive either the intervention 'intermittent preventive treatment in pregnancy' plus 'community-based scheduled screening and treatment (IPTp-SP Plus CSST) or continue with the current treatment, i.e. intermittent preventive treatment with sulfadoxine-pyrimethamine (IPTp-SP) at health facilities when they attend antenatal clinics (ANCs).

Schedule of interventions:
In the intervention arm, women will be encouraged by community health workers to attend the ANC as early as possible during their pregnancy. Health staff will give the first IPTp-SP dose after the first trimester of pregnancy and plan the second dose on the ANC card. Between ANC visits community health workers (CHWs) will perform a monthly rapid diagnostic test (RDT) until the last weeks of gestation and treat any positive woman with artemether-lumefantrine (AL).

In the control arm, women will be recruited at the first ANC visit where staff will explain the study, give the first IPTp-SP dose after the first trimester of pregnancy and plan the second dose on the ANC card.

All women (in both arms) will be encouraged to deliver at health facilities, where a blood sample for haemoglobin measurement and for detection of malaria will be collected just before delivery. A placenta biopsy will be collected at delivery and the newborn examined and weighed. For women not delivering in a health centre, a field assistant (FA) will follow them up at home and will collect the same information and biological samples as at health facilities.

Primary Outcome(s)

Placental malaria, at delivery a placental biopsy will be obtained that will be transferred to the Medical Research Council unit in the Gambia for histological analysis (presence of parasites and pigment deposition).

Secondary Outcome(s)

1. Maternal anaemia
2. Malaria peripheral infection
3. Low birth weight - newborns will be weighed as soon as possible after birth and gestational age will be established by the Ballard Score
4. IPTp-SP coverage by cluster (village/community), and selection of SP resistance markers
5. Antenatal clinic attendance and coverage of intermittent preventive treatment during pregnancy.

Secondary ID(s)

N/A

NCT01941264

Source(s) of Monetary Support

European Commission (Belgium) - ref: FP7-HEALTH-2012-INNOVATION-1305662

Ethics review

Status:
Approval date:
Contact:

1. Gambia Government/MRC laboratories Joint Ethics Committee, 25/06/2013, ref: SCC1336 2. Institutional Ethics Committee of Centre Muraz in Burkina Faso, 19/09/2013, ref A20-2013/CE-CM 3. Comite National d?Ethique pour la Recherché en Santé in Benin, 09/12/2013, No_0126/MS /DC/SGM /DFR /CNERS/SA

Results

• Results available: Yes
• Date Completed: 01/03/2015