NCT00118027

Brief Summary

SUMMARY Background: Malaria is the leading cause of morbidity and mortality among pregnant women in Uganda. Although effective tools for prevention and control of malaria exist, their delivery presents a problem. Intermittent presumptive treatment (IPT) with sulfadoxine-pyrimethamine (SP) is effective, yet \>60% of women in Uganda do not get it as \< 40%, attend antenatal care. Effective ways of delivering IPT with SP to pregnant women at a community level need to be developed. This study assessed whether community based resource persons like traditional birth attendants (TBAs), community reproductive health workers (CRHWs), adolescent peer mobilizers (APMs) and drug-shop owners (DSV) can distribute IPT with SP to pregnant women. Objectives: The objectives of this study were:

  • To assess community based approaches for delivering malaria prevention to pregnant women in Uganda;
  • To assess community perceptions, beliefs and practices associated with malaria treatment and prevention in pregnancy;
  • To assess whether community based resource persons can deliver IPT to pregnant women and reach those most at risk;
  • To assess the impact of IPT on anaemia and pregnancy outcome;
  • To estimate cost-effectiveness of the approaches and assess the acceptability and sustainability of the approaches. Methods: The study was conducted in 5 sub-counties of the Mukono district, situated on the shores of L. Victoria in Central Uganda. The district is hyper-endemic for malaria. 25 parishes with a total population of 75,000 people were used to test the new approaches. Phase 1 obtained qualitative data on community perceptions, beliefs and practices associated with malaria prevention in pregnancy. Phase 2 was an intervention study that assessed distribution of IPT to pregnant women by TBAs, CRHWs, APMs and DSVs compared with health units. Pregnant women of all parities were enrolled. Key resource persons in each parish were identified to sensitise the communities on the intervention. Data was collected regarding: timing of the first dose of SP, proportion of women who complete two doses of SP, birth weight of babies, proportion of low birth-weight babies, and proportion of adolescent pregnancies. The third phase of the study evaluated the sustainability of the approaches. Work Plan: The first phase of the study took two months. The second phase took 14-16 months. Data analysis was expected to take 12 months.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

June 30, 2005

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

January 12, 2017

Status Verified

January 1, 2017

First QC Date

June 30, 2005

Last Update Submit

January 11, 2017

Conditions

MalariaPregnancyAnemia

Keywords

Malaria in pregnancyAnaemiaLow birth weight

Outcome Measures

Primary Outcomes (11)

  • Timing of the first dose of SP.

  • Proportion of women who complete two doses of SP.

  • Birth weight of babies.

  • Proportion of low birth-weight babies.

  • Maternal haemoglobin and malaria parasite counts.

  • Proportion of adolescent pregnancies participating in the study.

  • Proportion of pregnant women who agree to take part in the study.

  • Proportion of scheduled visits completed by each delivery approach.

  • The costs per low birth weight of babies avoided.

  • The costs per anaemic pregnant woman avoided.

  • Mothers' perceptions on the four different SP delivery outlets

Interventions

sulphadoxine-pyrimethamine intermittent preventive treatmentDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant women of all parities and gestational week 16

You may not qualify if:

  • Pregnant women with a history of allergy to sulphonamide containing drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mukono District

Mukono, Central Uganda, P.O Box 7272, Uganda

Location

Related Links

MeSH Terms

Conditions

MalariaAnemia

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Anthony K Mbonye, MpH

    Ministry of Health, Uganda

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2005

First Posted

July 11, 2005

Study Start

May 1, 2003

Study Completion

June 1, 2007

Last Updated

January 12, 2017

Record last verified: 2017-01

Locations

UG(1)