NCT00964691

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,504

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Aug 2009

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

July 7, 2010

Status Verified

July 1, 2010

Enrollment Period

1 year

First QC Date

August 24, 2009

Last Update Submit

July 5, 2010

Conditions

MalariaMalaria in Pregnancy

Keywords

malariaIPTpFansidarIntermittent Preventive Treatment in pregnancypregnancyprophylaxisChloroquineAnemiaPreventionPlacental malariaSolomon IslandsLow birth weight

Outcome Measures

Primary Outcomes (1)

  • Placental malaria among primigravidae at time of delivery

    12 months

Secondary Outcomes (4)

  • 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

Study Arms (2)

Chloroquine prophylaxis

ACTIVE COMPARATOR

300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.

Drug: Chloroquine prophylaxis

IPTp with Sulphadoxine-pyrimethamine

ACTIVE COMPARATOR

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

Interventions

Sulphadoxine-pyrimethamineDRUG

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)

Also known as: Fansidar, IPTp/SP, SP
IPTp with Sulphadoxine-pyrimethamine
Chloroquine prophylaxisDRUG

300 mg weekly by mouth from the enrolment date until delivery. Only the enrolment dose will be supervised.

Also known as: CQ
Chloroquine prophylaxis

Eligibility Criteria

Age15 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Honiara City Council

Honiara, Solomon Islands

Location

Related Publications (1)

  • Wini L, Appleyard B, Bobogare A, Pikacha J, Seke J, Tuni M, Hou L, Hii J, McCarthy J, van Eijk AM. Intermittent preventive treatment with sulfadoxine-pyrimethamine versus weekly chloroquine prophylaxis for malaria in pregnancy in Honiara, Solomon Islands: a randomised trial. Malariaworld J. 2013 Jun 29;4:12. doi: 10.5281/zenodo.10894954. eCollection 2013.

    PMID: 38828109DERIVED

MeSH Terms

Conditions

MalariaAnemia

Interventions

fanasil, pyrimethamine drug combination

Condition Hierarchy (Ancestors)

Protozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Anna Maria van Eijk, MD PhD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

August 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

July 7, 2010

Record last verified: 2010-07

Locations

SO(1)