Preventing Malaria During Pregnancy in Epidemic-prone Areas.

January 11, 2017 updated by: Brian Greenwood, London School of Hygiene and Tropical Medicine

The Efficacy and Cost-effectiveness of Malaria Prevention in Pregnancy in an Area of Low and Unstable Transmission in Kabale, Uganda: Use of Intermittent Preventive Treatment and Insecticide-treated Nets.

The purpose of this study is to compare the efficacy and cost-effectiveness of three alternative strategies for the prevention of malaria during pregnancy in an epidemic-prone area of low transmission in the East African Highlands.

The strategies being compared are:

  • intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
  • an insecticide treated net (ITN), and
  • intermittent preventive treatment with SP plus an ITN

In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Susceptibility to malaria infection during pregnancy and the severity of clinical manifestation are determined by the level of pre-pregnancy immunity, which depends on intensity and stability of malaria transmission. Most intervention trials to prevent malaria during pregnancy have been conducted in areas of intense transmission. The results of trials conducted in high-transmission areas may not be applicable to low transmission areas, where malaria is less frequent but the risk of spontaneous abortion and stillbirth is very high in women of all parities due to lack of sufficient malaria immunity. Routine chemoprophylaxis is generally not recommended in areas of unstable malaria transmission. However, intermittent treatment with an effective anti-malarial drug may be beneficial, especially during periods of malaria transmission. Little work has been carried out amongst pregnant women living in areas of low and unstable transmission in Africa. No data are available on the cost-effectiveness of malaria control in low transmission settings.

This study will compare the efficacy and cost effectiveness of three preventive strategies for the control of malaria during pregnancy in low-transmission settings. The study is located in Kabale district, a highland area in SW Uganda.

Women attending antenatal care are randomised to receive either:

  • intermittent preventive treatment with sulfadoxine-pyrimethamine (IPT-SP)
  • an insecticide treated net (ITN), or
  • intermittent preventive treatment with SP and an ITN. It is hypothesized that when combined with IPT-SP, the additional impact of ITNs by reducing exposure may be greatest where the intensity of transmission is low.

In addition to the main individually-randomised trial, outcome data was subsequently also gathered on pregnant women whose houses where sprayed with indoor residual insecticides (IRS) as part of a non-randomised district-wide control programme to compare the impact of IRS with the three intervention arms.

The study aims to identify the most effective intervention strategies suited to areas characterised by low and unstable transmission. Research findings should be applicable to other hypoendemic areas of the East African highlands.

Study Type

Interventional

Enrollment (Actual)

4775

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Uganda
    • Kabale District
      • Kabale, Kabale District, Uganda
        • Kabale District Health Services (antenatal clinics at selected sites)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women whose pregnancies are at <27 weeks gestation at first antenatal booking
  • Permanent resident in study area
  • Informed consent

Exclusion Criteria:

  • Late presentation: pregnancies more than 26 weeks gestation at first antenatal booking
  • Severe anaemia (Hb<70g/L) on enrolment
  • Previous reaction to a sulfa-drug (e.g. sulphadoxine-pyrimethamine, septrin)
  • History of severe skin reaction to any drug
  • Current (or history) of severe disease (e.g. hepatitis, jaundice, TB, AIDS)

Withdrawal Criteria:

  • Withdrawal of consent
  • Women developing severe anaemia (Hb<70g/L)during pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine
Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine
Two doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion
Active Comparator: 2
Device: Insecticide-treated mosquito bed net
Device: Insecticide-treated mosquito bed net
Insecticide-treated mosquito bed net
Active Comparator: 3

Combination of Drug + Device:

Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine Device: Insecticide-treated mosquito bed net
Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine
Two doses given twice during pregnancy (once in the second trimester, and once in the third trimester). Oral medication in tablet form: single daily dose given on each occasion
Device: Insecticide-treated mosquito bed net
Insecticide-treated mosquito bed net

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
mean birthweight
Time Frame: April 2004-Jan 2007
April 2004-Jan 2007
prevalence of low birthweight
Time Frame: April 2004 - Jan 2007
April 2004 - Jan 2007

Secondary Outcome Measures

Outcome Measure
Time Frame
maternal anaemia - mean Hb at gestational age 36 weeks, prevalence of Hb<100g/L at gestational age 36 weeks
Time Frame: Feb 2003 - Jan 2007
Feb 2003 - Jan 2007
spontaneous abortions
Time Frame: Feb 2003 - Jan 2007
Feb 2003 - Jan 2007
stillbirths
Time Frame: April 2003-Jan 2007
April 2003-Jan 2007

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

Ministry of Health, Uganda

Investigators

  • Principal Investigator: Sian E Clarke, PhD, London School of Hygiene and Tropical Medicine, University of London, UK
  • Principal Investigator: Richard H Ndyomugyenyi, MBChB, PhD, Vector Control Division, Ministry of Health, Uganda
  • Principal Investigator: Pascal Magnussen, MD, DBL - Institute for Health Research and Development, Denmark
  • Principal Investigator: Kristian Schultz Hansen, PhD, DBL - Institute for Health Research and Development, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2004

Primary Completion (Actual)

January 1, 2007

Study Completion (Actual)

January 1, 2007

Study Registration Dates

First Submitted

August 31, 2005

First Submitted That Met QC Criteria

August 31, 2005

First Posted (Estimate)

September 2, 2005

Study Record Updates

Last Update Posted (Estimate)

January 12, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITDCVG32

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe