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Clinical Trials/NCT03508349
NCT03508349
Completed
Not Applicable

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

Jhpiego14 sites in 1 country1,786 target enrollmentSeptember 5, 2016

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Malaria in Pregnancy
Sponsor
Jhpiego
Enrollment
1786
Locations
14
Primary Endpoint
Prevalence of placental malaria at delivery (tested by PCR)
Status
Completed
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 5, 2016
End Date
March 18, 2019
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Sponsor
Jhpiego
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Prevalence of placental malaria at delivery (tested by PCR)

Time Frame: at the time of delivery

comparison of prevalence of malaria between women in intervention and control sites

Secondary Outcomes

  • Prevalence of low birth weight babies (<37 weeks gestation)(at the time of delivery)
  • Prevalence of maternal anemia at delivery(at the time of delivery)
  • Prevalence of preterm births(at the time of delivery)
  • Episodes of clinical malaria during the course of the pregnancy(assessed at the time of delivery)

Study Sites (14)

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