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Completed

NCT Number: NCT03508349

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

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.

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Key information

Conditions

Malaria in Pregnancy

Age range

18 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Busoro-Gishamvu Health Center, Huye, Southern Province, Rwanda

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IST

Diagnostic Test

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.

Primary outcomes

  1. Prevalence of placental malaria at delivery (tested by PCR)

    Time frame: at the time of delivery

    comparison of prevalence of malaria between women in intervention and control sites

Secondary outcomes

  1. Prevalence of maternal anemia at delivery

    Time frame: at the time of delivery

    comparison of prevalence of maternal anemia between women in intervention and control sites

  2. Prevalence of low birth weight babies (<37 weeks gestation)

    Time frame: at the time of delivery

    comparison of prevalence of LBW between women in intervention and control sites

  3. Prevalence of preterm births

    Time frame: at the time of delivery

    comparison of prevalence of preterm births between women in intervention and control sites

  4. Episodes of clinical malaria during the course of the pregnancy

    Time frame: assessed at the time of delivery

    description of the number of episodes of malaria detected during antenatal care visits during pregnancy

Other outcomes

  1. Adverse outcome of pregnancy - abortions, still births and neonatal deaths

    Time frame: assessed at the time of delivery

    Description of the number of adverse outcomes by group

Sponsors and collaborators

Lead sponsor

Jhpiego

Other

Collaborators

  • Centers for Disease Control and Prevention
  • Rwanda Malaria and Other Parasitic Diseases Division (MOPDD)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2019
First posted
Apr 25, 2018
Registry last updated
Dec 6, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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