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

This study has been terminated.
(Low prevalence of malaria, high prevalence of reported allergy to sulphur drugs, high proportion of women not meeting the inclusion criterea.)
Sponsor:
Collaborator:
World Health Organization
Information provided by:
Ministry of Health and Medical Services, Solomon Islands
ClinicalTrials.gov Identifier:
NCT00964691
First received: August 24, 2009
Last updated: July 5, 2010
Last verified: July 2010
  Purpose

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.


Condition Intervention Phase
Malaria
Malaria in Pregnancy
Drug: Sulphadoxine-pyrimethamine
Drug: Chloroquine prophylaxis
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine Versus Weekly Chloroquine Prophylaxis During Pregnancy in Solomon Islands: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ministry of Health and Medical Services, Solomon Islands:

Primary Outcome Measures:
  • Placental malaria among primigravidae at time of delivery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Low birth weight among primigravidae [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Maternal anaemia (Hb <11 g/dl) in the third trimester [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Maternal anaemia (Hb <11 g/dl) at delivery [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Malaria parasitemia at delivery [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 2504
Study Start Date: August 2009
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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:
  • Fansidar
  • IPTp/SP
  • SP
  • 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.

  Eligibility

Ages Eligible for Study:   15 Years to 49 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  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: NCT00964691

Locations
Solomon Islands
Honiara City Council
Honiara, Solomon Islands
Sponsors and Collaborators
Ministry of Health and Medical Services, Solomon Islands
World Health Organization
Investigators
Study Chair: Anna Maria van Eijk, MD PhD
  More Information

No publications provided

Responsible Party: Dr Lyndes Wini, Ministry of Health and Medical Services
ClinicalTrials.gov Identifier: NCT00964691     History of Changes
Other Study ID Numbers: 01-2009
Study First Received: August 24, 2009
Last Updated: July 5, 2010
Health Authority: Solomon Islands: National Health Research Ethics Committee

Keywords provided by Ministry of Health and Medical Services, Solomon Islands:
malaria
IPTp
Fansidar
Intermittent Preventive Treatment in pregnancy
pregnancy
prophylaxis
Chloroquine
Anemia
Prevention
Placental malaria
Solomon Islands
Low birth weight

Additional relevant MeSH terms:
Malaria
Protozoan Infections
Parasitic Diseases
Chloroquine
Chloroquine diphosphate
Sulfadoxine
Pyrimethamine
Fanasil, pyrimethamine drug combination
Amebicides
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antimalarials
Antirheumatic Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Filaricides
Antinematodal Agents
Anthelmintics
Central Nervous System Agents
Anti-Infective Agents, Urinary
Renal Agents
Folic Acid Antagonists

ClinicalTrials.gov processed this record on September 18, 2014