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

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.

Study Overview

• Status: Completed
• Conditions: Malaria in Pregnancy
• Intervention / Treatment: Diagnostic test: IST

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 Type: Interventional
• Enrollment (Actual): 1786
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Rwanda
  • South
    • Huye, South, Rwanda
      • 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
    • Kamonyi, South, Rwanda
      • Kamonyi Health Center
    • Kamonyi, South, Rwanda
      • Kayenzi Health Center
    • Kamonyi, South, Rwanda
      • Mugina Health Center
    • Kamonyi, South, Rwanda
      • Musambira Health Center
    • Kamonyi, South, Rwanda
      • Nyagihamba Health Center
    • Kamonyi, South, Rwanda
      • Nyamiyaga Health Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IST using RDT; 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.	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.
No Intervention: Routine Antenatal Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prevalence of placental malaria at delivery (tested by PCR)	comparison of prevalence of malaria between women in intervention and control sites	at the time of delivery

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse outcome of pregnancy - abortions, still births and neonatal deaths	Description of the number of adverse outcomes by group	assessed at the time of delivery

Collaborators and Investigators

• Sponsor: Jhpiego
• Collaborators: Centers for Disease Control and Prevention; Rwanda Malaria and Other Parasitic Diseases Division (MOPDD)
• Investigators: Principal Investigator: Reena Sethi, DrPH, Jhpiego

Study record dates

Study Major Dates

• Study Start (Actual): September 5, 2016
• Primary Completion (Actual): October 31, 2018
• Study Completion (Actual): March 18, 2019

Study Registration Dates

• First Submitted: January 23, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (Actual): April 25, 2018

Study Record Updates

• Last Update Posted (Actual): December 6, 2019
• Last Update Submitted That Met QC Criteria: December 4, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria
• Other Study ID Numbers: 6829

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No