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A New Approach to Deliver Malaria Preventions to Pregnant Women at a Community Level in Uganda

This study has been completed.
Sponsor:
Collaborators:
DBL -Institute for Health Research and Development
Ministry of Health, Uganda
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00118027
First received: June 30, 2005
Last updated: January 14, 2009
Last verified: January 2009
  Purpose

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.


Condition Intervention
Malaria
Pregnancy
Anemia
Drug: sulphadoxine-pyrimethamine intermittent preventive treatment

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A New Approach to Deliver Malaria Preventions to Pregnant Women at a Community Level in Uganda

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • 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

Estimated Enrollment: 2150
Study Start Date: May 2003
Study Completion Date: June 2007
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Pregnant women of all parities and gestational week 16

Exclusion Criteria:

  • Pregnant women with a history of allergy to sulphonamide containing drugs
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00118027

Locations
Uganda
Mukono District
Mukono, Central Uganda, Uganda, P.O Box 7272
Sponsors and Collaborators
Gates Malaria Partnership
DBL -Institute for Health Research and Development
Ministry of Health, Uganda
Investigators
Principal Investigator: Anthony K Mbonye, MpH Ministry of Health, Uganda
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00118027     History of Changes
Other Study ID Numbers: MV-713-624-02-0033
Study First Received: June 30, 2005
Last Updated: January 14, 2009
Health Authority: Uganda: National Council for Science and Technology

Keywords provided by Gates Malaria Partnership:
Malaria in pregnancy
Anaemia
Low birth weight

Additional relevant MeSH terms:
Malaria
Parasitic Diseases
Protozoan Infections
Fanasil, pyrimethamine drug combination
Pyrimethamine
Sulfadoxine
Anti-Infective Agents
Anti-Infective Agents, Urinary
Antimalarials
Antiparasitic Agents
Antiprotozoal Agents
Enzyme Inhibitors
Folic Acid Antagonists
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Renal Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014