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

Not Applicable

Completed

• Conditions: Malaria in Pregnancy

• Registration Number: NCT03508349
• Lead Sponsor: Jhpiego

Brief 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.

Study Timeline

• Study Start: 2016-09-05
• Study First Submitted: 2018-01-23
• Study First Submitted QC: 2018-04-16
• Study First Posted: 2018-04-25
• Primary Completion: 2018-10-31
• Study Completion: 2019-03-18
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1786

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Prevalence of placental malaria at delivery (tested by PCR)	at the time of delivery	comparison of prevalence of malaria between women in intervention and control sites

Secondary Outcome Measures

Name	Time	Method
Prevalence of low birth weight babies (<37 weeks gestation)	at the time of delivery	comparison of prevalence of LBW between women in intervention and control sites
Prevalence of maternal anemia at delivery	at the time of delivery	comparison of prevalence of maternal anemia between women in intervention and control sites
Prevalence of preterm births	at the time of delivery	comparison of prevalence of preterm births between women in intervention and control sites
Episodes of clinical malaria during the course of the pregnancy	assessed at the time of delivery	description of the number of episodes of malaria detected during antenatal care visits during pregnancy

Trial Locations

Locations (14)

Busoro-Gishamvu Health Center; 🇷🇼 Huye, South, Rwanda

Huye Police Health Center; 🇷🇼 Huye, South, Rwanda

Maraba Health Cente; 🇷🇼 Huye, South, Rwanda

Mukura Health Center; 🇷🇼 Huye, South, Rwanda

Rango Health Center; 🇷🇼 Huye, South, Rwanda

Rubona Health Center; 🇷🇼 Huye, South, Rwanda

Rwaniro; 🇷🇼 Huye, South, Rwanda

Sovu Health Center; 🇷🇼 Huye, South, Rwanda

Kamonyi Health Center; 🇷🇼 Kamonyi, South, Rwanda

Kayenzi Health Center; 🇷🇼 Kamonyi, South, Rwanda

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Busoro-Gishamvu Health Center

🇷🇼Huye, South, Rwanda