Status:
TERMINATED
A Randomized Controlled Trial for Intermittent Preventive Treatment in Pregnancy With Fansidar in Solomon Islands
Lead Sponsor:
Ministry of Health and Medical Services, Solomon Islands
Collaborating Sponsors:
World Health Organization
Conditions:
Malaria
Malaria in Pregnancy
Eligibility:
FEMALE
15-49 years
Phase:
PHASE4
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, Solomo...
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%...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2010
Estimated Enrollment :
2504 Patients enrolled
Trial Details
Trial ID
NCT00964691
Start Date
August 1 2009
End Date
August 1 2010
Last Update
July 7 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Honiara City Council
Honiara, Solomon Islands