Status:
COMPLETED
Efficacy,Safety and Tolerability of Dihydroartemisinin-Piperaquine for Uncomplicated Malaria in Pregnancy in Ghana
Lead Sponsor:
Kwame Nkrumah University of Science and Technology
Collaborating Sponsors:
Malaria Capacity Development Consortium
Conditions:
Pregnancy Complicated by Malaria as Antepartum Condition
Eligibility:
FEMALE
15-45 years
Phase:
PHASE3
Brief Summary
Malaria in pregnancy poses enormous public health challenges, contributing to significant maternal and infant deaths yearly. Adverse outcomes include maternal anaemia and low birthweight. Down regulat...
Detailed Description
Pregnant women of all ages, gravidity and with gestational ages 16-30 weeks, living within 15 km of the study center and presenting for antenatal care or diagnosed with uncomplicated malaria will be s...
Eligibility Criteria
Inclusion
- RDT positive + microscopy confirmed P. falciparum parasitaemia. ii) Informed consent. iii) Resident within the defined 15km radius of the study center. iv) No history of antimalarial treatment in the preceding two weeks. v) Assurance of adherence to study requirements, follow-up and delivery at the hospital.
- vi) Haemoglobin ≥ 7g/dl.
Exclusion
- i) Confirmed multiple gestation. ii) Severe malaria or disease likely to influence pregnancy outcome eg renal/ cardiac disease, diabetes mellitus, known pregnancy induced hypertension, known human immunodeficiency virus infection.
- iii) Known allergies to study medication. iv) Antimalarial treatment administered by a third party during the follow-up.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2013
Estimated Enrollment :
417 Patients enrolled
Trial Details
Trial ID
NCT01231113
Start Date
July 1 2011
End Date
February 1 2013
Last Update
February 24 2016
Active Locations (1)
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1
St.Michael's Hospital, Pramso
Kumasi, Ashanti Region, Ghana