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Clinical Trial Details — Status: Completed

Administrative data

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

Study information

Verified date December 2019
Source Jhpiego
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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