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

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

Further Study Details: 

Primary Outcomes: mean birthweight; prevalence of low birthweight
Secondary Outcomes: maternal anaemia - mean Hb at gestational age 36 weeks, prevalence of Hb<100g/L at gestational age 36 weeks; spontaneous abortions; stillbirths
Expected Total Enrollment:  4812

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.

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.

Genders Eligible for Study:  Female

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00142207

Richard H Ndyomugyenyi, MBChB, PhD      + 256 41348 332    notf@imul.com
Sian E Clarke, PhD      + 44 207 299 4642    sian.clarke@lshtm.ac.uk

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

Study chairs or principal investigators

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

Study ID Numbers:  ITDCVG32
Last Updated:  September 1, 2005
Record first received:  August 31, 2005
ClinicalTrials.gov Identifier:  NCT00142207
Health Authority: Uganda: Ministry of Health
ClinicalTrials.gov processed this record on 2005-09-06