Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda

Jhpiego

Status: Completed

Conditions: Malaria in Pregnancy

Treatments: Diagnostic Test: IST

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT03508349

6829

Details and patient eligibility

About

The main aim of this study is to test the primary hypothesis that the addition of intermittent screening and treatment of malaria in pregnant women (ISTp) who receive routine antenatal care (ANC) in health facilities in high malaria transmission areas in Rwanda will reduce malaria prevalence among pregnant women when compared to routine antenatal cares services alone.

Full description

More specifically, the primary objective is to understand the effect of ISTp in a context where routine antenatal care does not include malaria chemoprohylaxis and whether this intervention is protective against malaria during pregnancy. The secondary objective is to determine whether this intervention results in an improvement in other key maternal and newborn health outcomes including maternal anemia, low birth weight and prematurity. The third objective is to determine the feasibility, effectiveness and acceptability of ISTp among women who receive ISTp and among health workers who deliver this intervention.

This study will establish if testing and treating pregnant women is effective, feasible and whether it adds an additional burden to the work already being undertaken by facility-based health workers who provide antenatal care services. It is expected that the study will result in information to develop appropriate approaches that can be implemented in Rwanda in the prevention of malaria in pregnancy in addition to the use of preventive measures such as insecticide treated mosquito nets (ITNs) and case management. This information may potentially also be used by other countries with similar patterns of malaria transmission.

Enrollment: 1,786 patients

Sex: Female

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
• Willing to participate

Exclusion criteria

• • Pregnant women below the age of 18

  • Not willing to participate

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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1,786 participants in 2 patient groups

IST using RDT

Experimental group

Description:

Women presenting for their first ANC visit to facilities will be consecutively enrolled after providing informed consent. Women in the intervention group (IST+ routine care) will be tested for malaria at the health center during their ANC visits with an RDT. If positive, they will be treated with artemisinin-based combination therapy (ACT) in second or third trimester or quinine in the first trimester.

Treatment:

Diagnostic Test: IST

Routine Antenatal Care

No Intervention group

Description:

Women presenting for their first ANC visit to facilities will be consecutively enrolled after providing informed consent. Women in the comparison group (routine care) will receive routine antenatal care services per the national guidelines. They will not be tested for malaria at each antenatal care visit unless they are symptomatic for malaria.