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
1 other identifier
interventional
1,786
1 country
14
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2016
Typical duration for not_applicable
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 5, 2016
CompletedFirst Submitted
Initial submission to the registry
January 23, 2018
CompletedFirst Posted
Study publicly available on registry
April 25, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 18, 2019
CompletedDecember 6, 2019
December 1, 2019
2.2 years
January 23, 2018
December 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Prevalence of maternal anemia at delivery
at the time of delivery
Prevalence of low birth weight babies (<37 weeks gestation)
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
Other Outcomes (1)
Adverse outcome of pregnancy - abortions, still births and neonatal deaths
assessed at the time of delivery
Study Arms (2)
IST using RDT
EXPERIMENTALWomen 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.
Routine Antenatal Care
NO INTERVENTIONWomen 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
- Willing to participate
You may not qualify if:
- Pregnant women below the age of 18
- Not willing to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Jhpiegolead
- Rwanda Malaria and Other Parasitic Diseases Division (MOPDD)collaborator
- Centers for Disease Control and Preventioncollaborator
Study Sites (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
Mugina Health Center
Kamonyi, South, Rwanda
Musambira Health Center
Kamonyi, South, Rwanda
Nyagihamba Health Center
Kamonyi, South, Rwanda
Nyamiyaga Health Center
Kamonyi, South, Rwanda
Related Publications (2)
Alruwaili M, Uwimana A, Sethi R, Murindahabi M, Piercefield E, Umulisa N, Abram A, Eckert E, Munguti K, Mbituyumuremyi A, Gutman JR, Sullivan DJ. Peripheral and Placental Prevalence of Sulfadoxine-Pyrimethamine Resistance Markers in Plasmodium falciparum among Pregnant Women in Southern Province, Rwanda. Am J Trop Med Hyg. 2023 Oct 2;109(5):1057-1062. doi: 10.4269/ajtmh.23-0225. Print 2023 Nov 1.
PMID: 37783456DERIVEDUwimana A, Sethi R, Murindahabi M, Ntirandeka C, Piercefield E, Umulisa N, Abram A, Eckert E, Munguti K, Sullivan D, Uyizeye D, Mbituyumuremyi A, Gutman JR. Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy on Maternal and Birth Outcomes in Selected Districts in Rwanda: A Cluster Randomized Controlled Trial. Clin Infect Dis. 2023 Jul 5;77(1):127-134. doi: 10.1093/cid/ciad128.
PMID: 36896967DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Reena Sethi, DrPH
Jhpiego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2018
First Posted
April 25, 2018
Study Start
September 5, 2016
Primary Completion
October 31, 2018
Study Completion
March 18, 2019
Last Updated
December 6, 2019
Record last verified: 2019-12
Data Sharing
- IPD Sharing
- Will not share