The Impact of Sulphadoxine-Pyrimethamine Use At Scale on Newborn Outcomes in Nigeria

NCT02758353 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31493

Last updated 2016-05-02

No results posted yet for this study

Summary

The purpose of this study is to test the feasibility of the scale-up of sulphadoxine- pyrimethamine (SP) for the preventive treatment of malaria in pregnancy in three Local Government Areas (LGAs) in Sokoto State, Nigeria. The scale-up strategy tested included the introduction of community-based distribution of SP in addition to ongoing health facility distribution during antenatal care (ANC) visits. In addition, the study examined for the effect of SP use by participants during pregnancy on the head circumference of live newborns and on the odds of a baby being a stillborn. Finally, the investigators also sought to quantify the costs associated with program scale up SP to deliver at least three doses of SP per participant via a government operated distribution program.

Conditions

Interventions

DRUG

Community distribution of SP

SP delivered at both the community and facility level by trained CBHVs in three LGAs.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER
  • Federal Ministry of Health, Nigeria

    collaborator OTHER_GOV
  • JSI Research & Training Institute, Inc.

    lead OTHER

Principal Investigators

  • Nosa G Orobaton, MD, DrPH · John Snow, Inc.

Study Design

Allocation
NA
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2015-11-30
Completion
2015-11-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02758353 on ClinicalTrials.gov