Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda
- Conditions
- Malaria in Pregnancy
- Interventions
- Diagnostic Test: IST
- Registration Number
- NCT03508349
- Lead Sponsor
- Jhpiego
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1786
- Pregnant women age 18 or older who have their first ANC visit during the study recruitment period
- Willing to participate
-
• Pregnant women below the age of 18
- Not willing to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description IST using RDT IST 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.
- Primary Outcome Measures
Name Time Method Prevalence of placental malaria at delivery (tested by PCR) at the time of delivery comparison of prevalence of malaria between women in intervention and control sites
- Secondary Outcome Measures
Name Time Method Prevalence of low birth weight babies (<37 weeks gestation) at the time of delivery comparison of prevalence of LBW between women in intervention and control sites
Prevalence of maternal anemia at delivery at the time of delivery comparison of prevalence of maternal anemia between women in intervention and control sites
Prevalence of preterm births at the time of delivery comparison of prevalence of preterm births between women in intervention and control sites
Episodes of clinical malaria during the course of the pregnancy assessed at the time of delivery description of the number of episodes of malaria detected during antenatal care visits during pregnancy
Trial Locations
- Locations (14)
Mukura Health Center
🇷🇼Huye, South, Rwanda
Rango Health Center
🇷🇼Huye, South, Rwanda
Musambira Health Center
🇷🇼Kamonyi, South, Rwanda
Busoro-Gishamvu Health Center
🇷🇼Huye, South, Rwanda
Huye Police 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
Maraba Health Cente
🇷🇼Huye, South, Rwanda
Nyamiyaga Health Center
🇷🇼Kamonyi, South, Rwanda
Nyagihamba Health Center
🇷🇼Kamonyi, South, Rwanda