A Randomized Controlled Trial for Intermittent Preventive Treatment in Pregnancy With Fansidar in Solomon Islands (IPTpRCT)

Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine Versus Weekly Chloroquine Prophylaxis During Pregnancy in Solomon Islands: a Randomized Controlled Trial

The purpose of this study is to assess the effectiveness of intermittent preventive treatment in pregnancy (IPTp) with Sulphadoxine-pyrimethamine compared to chloroquine prophylaxis in Honiara, Solomon Islands for prevention of malaria and it's adverse effects in pregnancy.

Study Overview

• Status: Terminated
• Conditions: Malaria; Malaria in Pregnancy
• Intervention / Treatment: Drug: Chloroquine prophylaxis; Drug: Sulphadoxine-pyrimethamine

Detailed Description

Malaria is a major health problem in the Solomon Islands, with an annual estimated incidence of 158 per 1000 population in 2005, and P. falciparum and P. vivax responsible for respectively 71% and 29% of the clinical cases. Not much is known about the burden of malaria in pregnancy and the effectiveness of weekly chloroquine prophylaxis, the national policy for the prevention of malaria in pregnancy. In Honiara, the capital, 42.7% of the pregnant women are anaemic at their first antenatal clinic (ANC) visit. In a national data-base, clinical malaria in pregnancy was associated with an increased risk of anaemia. High levels of chloroquine drug resistance have been reported (67% treatment failure at day 28 in 2001). Among women who attended an ANC in Honiara and had been offered chloroquine prophylaxis, a high low birth weight risk among primigravidae compared to multigravidae was noted. This information indicates that the current policy may not be optimal for the prevention of malaria and its effects in pregnancy. Intermittent preventive treatment (IPTp) with sulfadoxine-pyrimethamine (SP) in pregnancy is an alternative strategy which has been introduced in many malarious countries in sub-Saharan Africa. Studies which compared IPTp with chloroquine prophylaxis in Africa showed that IPTp was more beneficial. Resistance to SP monotherapy in the Solomon islands has not been examined; however, the resistance to the combination of SP and chloroquine is low (< 10%). IPTp with SP has so far not been implemented in a region where P. vivax is common, and the effect of SP on P. vivax is not clear.

We propose a randomized controlled trial to assess the effectiveness of IPTp with SP compared to chloroquine prophylaxis in Honiara, the Solomon Islands. As outcome measures we will examine the effect on anaemia in third trimester, placental malaria, maternal anaemia at the time of delivery, infant birth weight, and prematurity. Outcomes in women allocated IPTp with SP will be compared with those allocated chloroquine prophylaxis. We expect 2504 women from Honiara City Council to participate in the randomised controlled trial. To assess the burden of malaria in pregnancy in other locations women we expect 1000 women to participate in a survey at the time of delivery among women not participating in the trial. At the end of this study, we will know the burden of malaria in pregnancy in Honiara and Guadalcanal, and we will be able to assist in developing evidence based national guidelines for malaria prevention among pregnant women in the Solomon Islands. The information obtained will be important for other areas and countries with a similar epidemiology of malaria in pregnancy.

• Study Type: Interventional
• Enrollment (Anticipated): 2504
• Phase: Phase 4

Contacts and Locations

Study Locations

• Solomon Islands
  • Honiara, Solomon Islands
    • Honiara City Council

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 49 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women aged 15 to 49 years
• Attending ANC clinic for the first time in this pregnancy
• Assigned routine ANC at a HCC health clinic
• Has experienced quickening (feeling the movements of the fetus)
• Gestation of 16 weeks to 32 weeks (as assessed by the last menstrual period [LMP] or by palpation if LMP is not available)
• Willing to adhere to all requirements of study
• Willing to provide informed written consent
• Planning to stay in Honiara for antenatal care and delivery

Exclusion Criteria:

• Used chloroquine prophylaxis in the current pregnancy before this ANC visit
• A history of allergic reaction to sulfa drugs (SP or cotrimoxazole
• Haemoglobin of < 7 g/dl
• Using folic acid in a dose of 5 mg daily (a dose of 1 mg daily or less is acceptable)
• Not willing to adhere to study requirements
• Women who are severely ill

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Chloroquine prophylaxis; 300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.	Drug: Chloroquine prophylaxis; 300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.; Other Names: CQ
Active Comparator: IPTp with Sulphadoxine-pyrimethamine; 3 tablets of SP (500 mg sulfadoxine and 25 mg pyrimethamine per tablet) by mouth under supervision at enrolment, and 3 tablets of SP under supervision 4 to 12 weeks later in pregnancy (timing of second dose depends upon gestation at first dose)	Drug: Sulphadoxine-pyrimethamine; 3 tablets of SP (500 mg sulfadoxine and 25 mg pyrimethamine per tablet) by mouth under supervision at enrolment, and 3 tablets of SP under supervision 4 to 12 weeks later in pregnancy (timing of second dose depends upon gestation at first dose); Other Names: SP; Fansidar; IPTp/SP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Placental malaria among primigravidae at time of delivery	12 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Low birth weight among primigravidae	12 months
Maternal anaemia (Hb <11 g/dl) in the third trimester	12 months
Maternal anaemia (Hb <11 g/dl) at delivery	12 months
Malaria parasitemia at delivery	12 months

Collaborators and Investigators

• Sponsor: Ministry of Health and Medical Services, Solomon Islands
• Collaborators: World Health Organization
• Investigators: Study Chair: Anna Maria van Eijk, MD PhD

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Anticipated): August 1, 2010
• Study Completion (Anticipated): August 1, 2010

Study Registration Dates

• First Submitted: August 24, 2009
• First Submitted That Met QC Criteria: August 24, 2009
• First Posted (Estimate): August 25, 2009

Study Record Updates

• Last Update Posted (Estimate): July 7, 2010
• Last Update Submitted That Met QC Criteria: July 5, 2010
• Last Verified: July 1, 2010

More Information

Terms related to this study

• Keywords: Anemia; pregnancy; Prevention; prophylaxis; malaria; Chloroquine; IPTp; Fansidar; Intermittent Preventive Treatment in pregnancy; Placental malaria; Solomon Islands; Low birth weight
• Additional Relevant MeSH Terms: Infections; Vector Borne Diseases; Parasitic Diseases; Protozoan Infections; Malaria; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Enzyme Inhibitors; Antirheumatic Agents; Antiprotozoal Agents; Antiparasitic Agents; Antimalarials; Amebicides; Folic Acid Antagonists; Anti-Infective Agents, Urinary; Renal Agents; Chloroquine; Pyrimethamine; Sulfadoxine; Fanasil, pyrimethamine drug combination
• Other Study ID Numbers: 01-2009

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No