Clinical trial NCT03508349: 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
Overall status: COMPLETED
Phase: NA
Conditions: Malaria in Pregnancy
Lead sponsor: Jhpiego
Sponsor class: OTHER
Collaborators: name: Rwanda Malaria and Other Parasitic Diseases Division (MOPDD)
name: Centers for Disease Control and Prevention
First posted: 2018-04-25
Enrollment: 1786
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Health facilities in high malaria transmission zones were pair matched and then randomized to be an intervention or a control facility.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Prevalence of placental malaria at delivery (tested by PCR)
timeFrame: at the time of delivery
Secondary outcomes:
measure: Prevalence of maternal anemia at delivery
timeFrame: at the time of delivery
measure: Prevalence of low birth weight babies (<37 weeks gestation)
timeFrame: at the time of delivery
measure: Prevalence of preterm births
timeFrame: at the time of delivery
measure: Episodes of clinical malaria during the course of the pregnancy
timeFrame: assessed at the time of delivery
Other outcomes:
measure: Adverse outcome of pregnancy - abortions, still births and neonatal deaths
timeFrame: assessed at the time of delivery
Locations:
city: Huye
country: Rwanda
facility: Busoro-Gishamvu Health Center
state: South
city: Huye
country: Rwanda
facility: Huye Police Health Center
state: South
city: Huye
country: Rwanda
facility: Maraba Health Cente
state: South
city: Huye
country: Rwanda
facility: Mukura Health Center
state: South
city: Huye
country: Rwanda
facility: Rango Health Center
state: South
city: Huye
country: Rwanda
facility: Rubona Health Center
state: South
city: Huye
country: Rwanda
facility: Rwaniro
state: South
city: Huye
country: Rwanda
facility: Sovu Health Center
state: South
city: Kamonyi
country: Rwanda
facility: Kamonyi Health Center
state: South
city: Kamonyi
country: Rwanda
facility: Kayenzi Health Center
state: South
city: Kamonyi
country: Rwanda
facility: Mugina Health Center
state: South
city: Kamonyi
country: Rwanda
facility: Musambira Health Center
state: South
city: Kamonyi
country: Rwanda
facility: Nyagihamba Health Center
state: South
city: Kamonyi
country: Rwanda
facility: Nyamiyaga Health Center
state: South
Study officials:
affiliation: Jhpiego
name: Reena Sethi, DrPH
role: PRINCIPAL_INVESTIGATOR
References: