Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda
NCT ID: NCT03508349
Last Updated: 2019-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
1786 participants
INTERVENTIONAL
2016-09-05
2019-03-18
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Willing to participate
Exclusion Criteria
* Not willing to participate
18 Years
49 Years
FEMALE
Yes
Sponsors
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Rwanda Malaria and Other Parasitic Diseases Division (MOPDD)
UNKNOWN
Centers for Disease Control and Prevention
FED
Jhpiego
OTHER
Responsible Party
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Principal Investigators
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Reena Sethi, DrPH
Role: PRINCIPAL_INVESTIGATOR
Jhpiego
Locations
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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
Countries
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References
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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.
Uwimana 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.
Other Identifiers
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6829
Identifier Type: -
Identifier Source: org_study_id