Routine Antenatal Care Versus Screening and Treatment of Malaria in Pregnancy in Rwanda

Study Overview
=================
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.

Official Title
-----------------
Effectiveness of Intermittent Screening and Treatment of Malaria in Pregnancy (ISTp) on Maternal and Birth Outcomes in Selected Districts in Rwanda

Conditions
-----------------
Malaria in Pregnancy

Intervention / Treatment
-----------------
* Diagnostic Test: IST


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Health facilities in high malaria transmission zones were pair matched and then randomized to be an intervention or a control facility.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IST using RDT<br>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. | Diagnostic Test: IST<br>* 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.<br>|
| No Intervention: Routine Antenatal Care<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of maternal anemia at delivery | comparison of prevalence of maternal anemia between women in intervention and control sites | at the time of delivery | 
| 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 | 
| Prevalence of preterm births | comparison of prevalence of preterm births between women in intervention and control sites | at the time of delivery | 
| 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 |