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Trial record 1 of 4 for:    Solomon | Solomon Islands
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A Randomized Controlled Trial for Intermittent Preventive Treatment in Pregnancy With Fansidar in Solomon Islands (IPTpRCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00964691
Recruitment Status : Terminated (Low prevalence of malaria, high prevalence of reported allergy to sulphur drugs, high proportion of women not meeting the inclusion criterea.)
First Posted : August 25, 2009
Last Update Posted : July 7, 2010
Sponsor:
Collaborator:
World Health Organization
Information provided by:
Ministry of Health and Medical Services, Solomon Islands

Tracking Information
First Submitted Date  ICMJE August 24, 2009
First Posted Date  ICMJE August 25, 2009
Last Update Posted Date July 7, 2010
Study Start Date  ICMJE August 2009
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 24, 2009)
Placental malaria among primigravidae at time of delivery [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00964691 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 24, 2009)
  • Low birth weight among primigravidae [ Time Frame: 12 months ]
  • Maternal anaemia (Hb <11 g/dl) in the third trimester [ Time Frame: 12 months ]
  • Maternal anaemia (Hb <11 g/dl) at delivery [ Time Frame: 12 months ]
  • Malaria parasitemia at delivery [ Time Frame: 12 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Randomized Controlled Trial for Intermittent Preventive Treatment in Pregnancy With Fansidar in Solomon Islands
Official Title  ICMJE Intermittent Preventive Treatment With Sulfadoxine-Pyrimethamine Versus Weekly Chloroquine Prophylaxis During Pregnancy in Solomon Islands: a Randomized Controlled Trial
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Malaria
  • Malaria in Pregnancy
Intervention  ICMJE
  • 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
  • Drug: Chloroquine prophylaxis
    300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.
    Other Name: CQ
Study Arms  ICMJE
  • Active Comparator: Chloroquine prophylaxis
    300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.
    Intervention: Drug: Chloroquine prophylaxis
  • 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)
    Intervention: Drug: Sulphadoxine-pyrimethamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Estimated Enrollment  ICMJE
 (submitted: August 24, 2009)
2504
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2010
Estimated Primary Completion Date August 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 15 Years to 49 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Solomon Islands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00964691
Other Study ID Numbers  ICMJE 01-2009
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Dr Lyndes Wini, Ministry of Health and Medical Services
Study Sponsor  ICMJE Ministry of Health and Medical Services, Solomon Islands
Collaborators  ICMJE World Health Organization
Investigators  ICMJE
Study Chair: Anna Maria van Eijk, MD PhD
PRS Account Ministry of Health and Medical Services, Solomon Islands
Verification Date July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP