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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03508349
• Other study ID #: 6829
• Status: Completed
• Phase: N/A
• Start date: September 5, 2016
• Est. completion date: March 18, 2019

Study information

• Verified date: December 2019
• Source: Jhpiego
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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

Related Conditions & MeSH terms

• Malaria
• Malaria in Pregnancy

Intervention

Diagnostic Test:
• 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.

Locations

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

Sponsors (3)

Lead Sponsor	Collaborator
Jhpiego	Centers for Disease Control and Prevention, Rwanda Malaria and Other Parasitic Diseases Division (MOPDD)

Country where clinical trial is conducted

Rwanda, 

Outcome

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