Preventing Malaria During Pregnancy in Epidemic-Prone Areas.

This study has been completed.
Sponsor:
Collaborator:
Ministry of Health, Uganda
Information provided by:
Gates Malaria Partnership
ClinicalTrials.gov Identifier:
NCT00142207
First received: August 31, 2005
Last updated: February 7, 2008
Last verified: February 2008
  Purpose

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.


Condition Intervention Phase
Malaria, Falciparum
Drug: Intermittent preventive treatment:sulphadoxine-pyrimethamine
Device: Insecticide-treated mosquito bed net
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Gates Malaria Partnership:

Primary Outcome Measures:
  • mean birthweight [ Time Frame: April 2004-Jan 2007 ] [ Designated as safety issue: No ]
  • prevalence of low birthweight [ Time Frame: April 2004 - Jan 2007 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • spontaneous abortions [ Time Frame: Feb 2003 - Jan 2007 ] [ Designated as safety issue: No ]
  • stillbirths [ Time Frame: April 2003-Jan 2007 ] [ Designated as safety issue: No ]

Enrollment: 4775
Study Start Date: January 2004
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

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

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
  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: NCT00142207

Locations
Uganda
Kabale District Health Services (antenatal clinics at selected sites)
Kabale, Kabale District, Uganda
Sponsors and Collaborators
Gates Malaria Partnership
Ministry of Health, Uganda
Investigators
Principal Investigator: Richard H Ndyomugyenyi, MBChB, PhD Vector Control Division, Ministry of Health, Uganda
Principal Investigator: Sian E Clarke, PhD London School of Hygiene and Tropical Medicine, University of London, UK
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
  More Information

Publications:
Ndyomugyenyi R, Clarke S, Chandramohan D, Twesigomwe T & Magnussen P. (2005). Epidemiology of pregnancy-associated malaria in the Ugandan highlands [abstract]. Acta Tropica, Suppl 95: S448.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00142207     History of Changes
Other Study ID Numbers: ITDCVG32
Study First Received: August 31, 2005
Last Updated: February 7, 2008
Health Authority: Uganda: Ministry of Health

Keywords provided by Gates Malaria Partnership:
malaria
pregnancy
intermittent preventive treatment
insecticide-treated nets

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Fanasil, pyrimethamine drug combination
Pyrimethamine
Sulfadoxine
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 October 19, 2014