Assessment of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi

February 5, 2013 updated by: Centers for Disease Control and Prevention

Assessment of the Efficacy and Effectiveness of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi

The purpose of this study is to determine the efficacy and effectiveness of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy for reducing malaria-associated morbidity in pregnant women in Malawi.

Study Overview

Status

Completed

Conditions

Detailed Description

Malaria infection in pregnancy is associated with severe maternal anemia, placental parasitemia, low birth weight, and increased perinatal mortality. Intermittent preventive treatment in pregnancy (IPTp) with sulphadoxine-pyrimethamine (SP) is recommended by the World Health Organization (WHO) for reducing the risks associated with malaria in pregnancy. Traditionally, the level of SP resistance has been assessed by monitoring its in vivo efficacy for treatment of uncomplicated malaria in children under five years of age. However, parasite resistance to SP has compromised its efficacy in young children, and SP is no the longer a first-line recommended treatment for malaria in most African countries. Although SP currently appears to remain effective for IPTp in pregnant women probably because they have more immunity than young children, it is important to monitor SP effectiveness in this population. Characterizing SP resistance through in vivo and molecular methods in pregnant women may be useful to predict whether to continue a policy of IPTp with SP.

There will be three parts to this study. To determine therapeutic efficacy of SP IPTp in pregnant women, a prospective in vivo study will be done in women who present for antenatal care (ANC). Women will receive SP IPTp according to national guidelines and will be followed for 42 days for clearance of peripheral parasitemia. To determine birth outcomes of women given SP IPTp, a retrospective cohort study will be performed assessing outcomes of women at delivery. Information on prior receipt of SP IPTp, peripheral and placental parasitemia at delivery, placental histology, maternal anemia, and birth weight will be collected. To characterize baseline resistance of SP in pregnant women and in the general population, parasites will be collected from both participating women and attendees at outpatient clinics to measure SP resistance markers.

The results of this study will be used by the Malawi national control program to evaluate current policy of using SP for IPTp. This study will also contribute towards an international effort led by WHO to align priorities and methodologies in gathering data on the efficacy of SP in IPTp in the face of increasing SP resistance, thus providing data to inform IPTp policy at the global level.

Study Type

Observational

Enrollment (Actual)

1410

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

  • Malawi
    • Machinga District
      • Liwonde, Machinga District, Malawi
        • Machinga District Hospital

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

All

Sampling Method

Non-Probability Sample

Study Population

Therapeutic efficacy study: Asymptomatic parasitemic pregnant women at 16-26 weeks of gestation Birth outcomes study: Pregnant women presenting for delivery Characterizing molecular markers of SP resistance study: Parasitemic outpatients

Description

Therapeutic efficacy study

Inclusion Criteria:

  • 16-26 weeks gestation based on last menstrual period (LMP) or quickening
  • Axillary temperature <37.5 degrees Celsius
  • Informed consent

Exclusion Criteria:

  • History of hypersensitivity reaction to SP or components of SP
  • Axillary temperature ≥37.5 degrees C
  • History of receipt of antimalarials in the past month
  • Known HIV infection

Birth outcomes study:

Inclusion Criteria:

  • Singleton pregnancy
  • SP IPTp history available
  • Informed consent

Exclusion Criteria:

  • Blood transfusion after the 16th gestational week
  • Receipt of antimalarials other than SP for IPTp after 16th gestational week
  • Known HIV infection

Characterizing molecular markers of SP resistance:

Inclusion Criteria:

  • Outpatient attending selected health facility
  • Informed consent

Exclusion Criteria:

  • None

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

Cohorts and Interventions

Group / Cohort
Therapeutic efficacy study
Asymptomatic parasitemic pregnant women at 16-26 weeks of gestation will be enrolled into the study and followed weekly for 42 days after the receipt of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy to assess the clearance of parasitemia.
Birth outcomes study
Women presenting for delivery will be enrolled and assessed for a history of sulphadoxine-pyrimethamine intermittent preventive treatment in pregnancy and evidence of malaria infection by placental histology, maternal peripheral parasitemia, maternal anemia and infant cord blood parasitemia.
Characterizing molecular markers of SP resistance
Parasitemic outpatients attending the health facility will be tested for parasite molecular markers of sulphadoxine-pyrimethamine resistance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Therapeutic efficacy study: Development of fever or symptoms of severe malaria (defined by WHO) and parasitemia at any time after the first dose of SP during the 42 day follow up period
Time Frame: 42 days
42 days
Birth outcomes study: Evidence of malaria infection based on placental histology at the time of delivery
Time Frame: At time of birth
At time of birth
Characterizing molecular markers of SP resistance: Prevalence of molecular markers of sulphadoxine-pyrimethamine resistance at the time of health facility visit
Time Frame: Day 1
Day 1

Collaborators and Investigators

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

Sponsor

Centers for Disease Control and Prevention

Collaborators

Kamuzu University of Health Sciences

Investigators

  • Principal Investigator: Jacek Skarbinski, MD, Malaria Branch, Centers for Disease Control and Prevention
  • Principal Investigator: Don Mathanga, MD, PhD, Kamuzu University of Health Sciences

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

March 1, 2010

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

May 5, 2010

First Submitted That Met QC Criteria

May 7, 2010

First Posted (Estimate)

May 10, 2010

Study Record Updates

Last Update Posted (Estimate)

February 6, 2013

Last Update Submitted That Met QC Criteria

February 5, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDC-CGH-5756

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.

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