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

Primary Purpose

Malaria in Pregnancy

Status
Completed
Phase
Not Applicable
Locations
Rwanda
Study Type
Interventional
Intervention
IST
Sponsored by
Jhpiego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Malaria in Pregnancy

Eligibility Criteria

18 Years - 49 Years (Adult)FemaleAccepts 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

Sites / Locations

  • Busoro-Gishamvu Health Center
  • Huye Police Health Center
  • Maraba Health Cente
  • Mukura Health Center
  • Rango Health Center
  • Rubona Health Center
  • Rwaniro
  • Sovu Health Center
  • Kamonyi Health Center
  • Kayenzi Health Center
  • Mugina Health Center
  • Musambira Health Center
  • Nyagihamba Health Center
  • Nyamiyaga Health Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IST using RDT

Routine Antenatal Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Prevalence of maternal anemia at delivery
comparison of prevalence of maternal anemia between women in intervention and control sites
Prevalence of low birth weight babies (<37 weeks gestation)
comparison of prevalence of LBW between women in intervention and control sites
Prevalence of preterm births
comparison of prevalence of preterm births between women in intervention and control sites
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

Full Information

First Posted
January 23, 2018
Last Updated
December 4, 2019
Sponsor
Jhpiego
Collaborators
Rwanda Malaria and Other Parasitic Diseases Division (MOPDD), Centers for Disease Control and Prevention
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1. Study Identification

Unique Protocol Identification Number
NCT03508349
Brief Title
Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda
Official Title
Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy (ISTp) on Maternal and Birth Outcomes in Selected Districts in Rwanda
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
September 5, 2016 (Actual)
Primary Completion Date
October 31, 2018 (Actual)
Study Completion Date
March 18, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jhpiego
Collaborators
Rwanda Malaria and Other Parasitic Diseases Division (MOPDD), Centers for Disease Control and Prevention

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria in Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Health facilities in high malaria transmission zones were pair matched and then randomized to be an intervention or a control facility.
Masking
Participant
Allocation
Randomized
Enrollment
1786 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IST using RDT
Arm Type
Experimental
Arm 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.
Arm Title
Routine Antenatal Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
IST
Intervention Description
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.
Primary Outcome Measure Information:
Title
Prevalence of placental malaria at delivery (tested by PCR)
Description
comparison of prevalence of malaria between women in intervention and control sites
Time Frame
at the time of delivery
Secondary Outcome Measure Information:
Title
Prevalence of maternal anemia at delivery
Description
comparison of prevalence of maternal anemia between women in intervention and control sites
Time Frame
at the time of delivery
Title
Prevalence of low birth weight babies (<37 weeks gestation)
Description
comparison of prevalence of LBW between women in intervention and control sites
Time Frame
at the time of delivery
Title
Prevalence of preterm births
Description
comparison of prevalence of preterm births between women in intervention and control sites
Time Frame
at the time of delivery
Title
Episodes of clinical malaria during the course of the pregnancy
Description
description of the number of episodes of malaria detected during antenatal care visits during pregnancy
Time Frame
assessed at the time of delivery
Other Pre-specified Outcome Measures:
Title
Adverse outcome of pregnancy - abortions, still births and neonatal deaths
Description
Description of the number of adverse outcomes by group
Time Frame
assessed at the time of delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
pregnant at the time of enrollment in the study
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Reena Sethi, DrPH
Organizational Affiliation
Jhpiego
Official's Role
Principal Investigator
Facility Information:
Facility Name
Busoro-Gishamvu Health Center
City
Huye
State/Province
South
Country
Rwanda
Facility Name
Huye Police Health Center
City
Huye
State/Province
South
Country
Rwanda
Facility Name
Maraba Health Cente
City
Huye
State/Province
South
Country
Rwanda
Facility Name
Mukura Health Center
City
Huye
State/Province
South
Country
Rwanda
Facility Name
Rango Health Center
City
Huye
State/Province
South
Country
Rwanda
Facility Name
Rubona Health Center
City
Huye
State/Province
South
Country
Rwanda
Facility Name
Rwaniro
City
Huye
State/Province
South
Country
Rwanda
Facility Name
Sovu Health Center
City
Huye
State/Province
South
Country
Rwanda
Facility Name
Kamonyi Health Center
City
Kamonyi
State/Province
South
Country
Rwanda
Facility Name
Kayenzi Health Center
City
Kamonyi
State/Province
South
Country
Rwanda
Facility Name
Mugina Health Center
City
Kamonyi
State/Province
South
Country
Rwanda
Facility Name
Musambira Health Center
City
Kamonyi
State/Province
South
Country
Rwanda
Facility Name
Nyagihamba Health Center
City
Kamonyi
State/Province
South
Country
Rwanda
Facility Name
Nyamiyaga Health Center
City
Kamonyi
State/Province
South
Country
Rwanda

12. IPD Sharing Statement

Plan to Share IPD
No

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

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