Preventing Malaria During Pregnancy in Epidemic-prone Areas.

Malaria, Falciparum Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00142207
• Other study ID #: ITDCVG32
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2005
• Last updated: January 11, 2017
• Start date: January 2004
• Est. completion date: January 2007

Study information

• Verified date: January 2017
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: Uganda: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4775
• Est. completion date: January 2007
• Est. primary completion date: January 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

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

Locations

Country	Name	City	State
Uganda	Kabale District Health Services (antenatal clinics at selected sites)	Kabale	Kabale District

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Ministry of Health, Uganda

Country where clinical trial is conducted

Uganda, 

References & Publications (1)

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean birthweight		April 2004-Jan 2007	No
Primary	prevalence of low birthweight		April 2004 - Jan 2007	No
Secondary	maternal anaemia - mean Hb at gestational age 36 weeks, prevalence of Hb<100g/L at gestational age 36 weeks		Feb 2003 - Jan 2007	No
Secondary	spontaneous abortions		Feb 2003 - Jan 2007	No
Secondary	stillbirths		April 2003-Jan 2007	No