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

This study has been completed.
Sponsor:
Collaborator:
University of Malawi College of Medicine
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT01120145
First received: May 5, 2010
Last updated: February 5, 2013
Last verified: February 2013
  Purpose

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.


Condition
Malaria in Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Assessment of the Efficacy and Effectiveness of Sulphadoxine-pyrimethamine for Intermittent Preventive Treatment of Malaria in Pregnancy in Malawi

Resource links provided by NLM:


Further study details as provided by Centers for Disease Control and Prevention:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Birth outcomes study: Evidence of malaria infection based on placental histology at the time of delivery [ Time Frame: At time of birth ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Blood spots will be collected from parasitemic patients to look at malaria prasite molecular markers of resistance to sulphadoxine-pyrimethamine.


Enrollment: 1410
Study Start Date: March 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

Criteria

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
  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: NCT01120145

Locations
Malawi
Machinga District Hospital
Liwonde, Machinga District, Malawi
Sponsors and Collaborators
University of Malawi College of Medicine
Investigators
Principal Investigator: Jacek Skarbinski, MD Malaria Branch, Centers for Disease Control and Prevention
Principal Investigator: Don Mathanga, MD, PhD University of Malawi College of Medicine
  More Information

No publications provided

Responsible Party: Jacek Skarbinski, Malaria Branch, Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT01120145     History of Changes
Other Study ID Numbers: CDC-CGH-5756
Study First Received: May 5, 2010
Last Updated: February 5, 2013
Health Authority: United States: Federal Government
Malawi: College of Medicine Research and Ethics Committee

Keywords provided by Centers for Disease Control and Prevention:
Malaria
Pregnancy
Sulphadoxine-pyrimethamine

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

ClinicalTrials.gov processed this record on July 24, 2014