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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE4

Total Enrollment

2504 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-31

Study Completion Date

2010-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Sulfadoxine-pyrimethamine Plus Dihydroartemisinin-piperaquine for Intermittent Preventive Treatment in Pregnancy

NCT05426434

Malaria Malaria in Pregnancy Pregnancy Related

ACTIVE_NOT_RECRUITING PHASE3

Evaluate Azithromycin Plus Chloroquine And Sulfadoxine Plus Pyrimethamine Combinations For Intermittent Preventive Treatment Of Falciparum Malaria Infection In Pregnant Women In Africa

NCT01103063

Intermittent Preventive Treatment In Pregnancy (IPTp)

TERMINATED PHASE3

Efficacy and Safety of Sulphadoxine-pyrimethamine and Amodiaquine in Ghanaian Pregnant Women

NCT00131703

Malaria Pregnancy

COMPLETED PHASE3

Evaluation of Alternative Antimalarial Drugs for Malaria in Pregnancy

NCT00811421

Pregnancy Malaria HIV Infections

COMPLETED NA

Prevention of P. Vivax Malaria During Pregnancy in Bolivia

NCT00290420

Malaria

WITHDRAWN PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Malaria Malaria in Pregnancy

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Chloroquine prophylaxis

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

Group Type ACTIVE_COMPARATOR

Chloroquine prophylaxis

Intervention Type DRUG

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

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)

Group Type ACTIVE_COMPARATOR

Sulphadoxine-pyrimethamine

Intervention Type DRUG

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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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 Type DRUG

Chloroquine prophylaxis

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

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Fansidar IPTp/SP SP CQ

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

15 Years

Maximum Eligible Age

49 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes