Overview

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

Status:
Terminated
Trial end date:
2010-08-01
Target enrollment:
0
Participant gender:
Female
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.
Phase:
Phase 4
Accepts Healthy Volunteers?
Accepts Healthy Volunteers
Details
Lead Sponsor:
Ministry of Health and Medical Services, Solomon Islands
Collaborator:
World Health Organization
Treatments:
Chloroquine
Chloroquine diphosphate
Fanasil, pyrimethamine drug combination
Pyrimethamine
Sulfadoxine
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