NCT03508349

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

Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy (ISTp) on Maternal and Birth Outcomes in Selected Districts in Rwanda

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,786 (actual)
• Sponsor: Jhpiego · Academic / Other
• Sex: Female
• Age: 18 Years – 49 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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.

Conditions

• Malaria in Pregnancy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	IST	Women in the control group will receive routine care, which does not include testing for malaria with a rapid diagnostic test unless symptomatic for malaria. Women in the intervention group will receive this additional testing for malaria at each antenatal care, regardless of whether she is symptomatic for malaria.

Timeline

• Start date: 2016-09-05
• Primary completion: 2018-10-31
• Completion: 2019-03-18
• First posted: 2018-04-25
• Last updated: 2019-12-06

Locations

14 sites across 1 country: Rwanda