Sulphadoxine/Pyrimethamine and Proguanil for malaria prophylaxis in Sickle Cell pregnancy: A Randomized Controlled Trial (SPICKLE TRIAL)
Not Applicable
- Conditions
- Malaria
- Registration Number
- PACTR201802003063273
- Lead Sponsor
- EDCTP
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- Female
- Target Recruitment
- 248
Inclusion Criteria
¿Pregnant women of all gravidity confirmed as having HbSS genotype.
¿Screened after 16 weeks or onset of quickening, both aparasitaemic and parasitaemic at first enrolment.
¿Must give informed written consent.
Exclusion Criteria
¿Known adverse drug reaction to any of the two medications (Sulphadoxine/Pyrimethamine and Proguanil).
¿Co-existing medical disorders that may alter immunity such as diabetes mellitus (DM) and human immunodeficiency virus infection (HIV).
¿Multiple gestations.
¿Presence of severe clinical malaria at booking.
¿Less than 16 weeks gestational age for Sulphadoxine/Pyrimethamine (SP) group.
¿Use of antimalarials within the last one week prior to booking.
¿Refusal to give informed written consent.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method