Community-based Screening and Treatment of Malaria in Pregnancy: a Cluster-randomized Trial

Summary

Malaria is a common disease in Africa and a major health problem. Pregnant women are also at risk of malaria. Malaria in pregnancy is life threatening to both the mother and the baby she is carrying. It can result in the destruction of the mother's blood and in babies with a lower birth weight than normal, making them less healthy in their first years of life. These risks are even higher in women having their first pregnancy.

When a woman is pregnant she should go to the Antenatal clinic (ANC) for care. Usually the ANC health staff gives the woman intermittent preventable treatment (IPTp-SP) against malaria. This drug helps protect the woman against getting malaria. Each pregnant woman should receive at least 2 doses of this drug during their pregnancy; thus, they should go the ANC at least 2 times during their pregnancy. However, many women still do not go often to the ANC for health care during their pregnancy.

This study would like to see whether community health workers (CHW) can work with pregnant women to encourage them to attend ANC more often. Also, the CHW will test a pregnant woman every month for malaria with a rapid test. If a woman has malaria, the CHW will treat her in her home instead of the woman having to go a health clinic for treatment. The woman will be treated with a different drug than the drug that is given at the ANC visits. Our hypothesis is that this will improve the care and management of malaria during pregnancy and this will improve the health of women and their newborns. To see whether this strategy improved the health of women and their newborns, we will take a small piece of the placenta at delivery to test for malaria and we will weigh the baby. We will test this strategy in multiple communities. We will compare this to pregnant women in communities where this strategy was not followed, thus where pregnant women received standard care.

Participants will be pregnant women. There are no direct benefits for participating in the study, except the outcome of our research question that is possible health benefits in the intervention group. The drugs involved are tested safe in pregnant women from second trimester on.

Conditions

• Malaria, Antepartum
• Maternal Malaria During Pregnancy - Baby Not Yet Delivered
• Small for Gestational Age (Disorder)

Interventions

OTHER

community based screening and treatment

Already described in intervention arm description.

Sponsors & Collaborators

• Medical Research Council Unit, The Gambia

  collaborator OTHER

• Centre Muraz

  collaborator OTHER

• Imperial College London

  collaborator OTHER

• World Health Organization

  collaborator OTHER

• European Union

  collaborator OTHER

• Royal Tropical Institute

  lead OTHER

Principal Investigators

• Henk Schallig, Dr · Royal Tropical Institute (KIT)

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

16 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2013-10-31

Primary Completion

2016-05-31

Completion

2016-05-31

Countries

• Benin
• Burkina Faso
• The Gambia

Study Locations