Malaria in Pregnancy Clinical Trial
Official title:
Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy (ISTp) on Maternal and Birth Outcomes in Selected Districts in Rwanda
NCT number | NCT03508349 |
Other study ID # | 6829 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | September 5, 2016 |
Est. completion date | March 18, 2019 |
Verified date | December 2019 |
Source | Jhpiego |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 1786 |
Est. completion date | March 18, 2019 |
Est. primary completion date | October 31, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 49 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
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 | 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 |
Lead Sponsor | Collaborator |
---|---|
Jhpiego | Centers for Disease Control and Prevention, Rwanda Malaria and Other Parasitic Diseases Division (MOPDD) |
Rwanda,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | Prevalence of maternal anemia at delivery | comparison of prevalence of maternal anemia between women in intervention and control sites | at the time of delivery | |
Secondary | 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 | |
Secondary | Prevalence of preterm births | comparison of prevalence of preterm births between women in intervention and control sites | at the time of delivery | |
Secondary | 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 |
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