Malaria Prevention in pregnancy in Tanzania
- Conditions
- Malaria
- Registration Number
- PACTR201612001901313
- Lead Sponsor
- MUHAS
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- Female
- Target Recruitment
- 1000
i.Viable pregnancy assessed by UPT
ii.Gestational age 16 to 32 weeks (inclusive) determined by fundal height
iii. No prior history of IPTp use for current pregnancy
iv.Willing to participate and complete the study schedule
v.Willing to sign or thumb print informed consent
vi. Resident of study area and intending to stay in the area for the duration of the follow-up
vii.Willing to deliver at the health facility
i.Residence outside study area or planning to move out in the 12 months following enrolment
ii.High risk pregnancy, including any pre-existing illness likely to cause complication of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, liver disease, fistula repair, leg or spine deformity)
iii.Severe anemia requiring blood transfusion (Hb ¿ 7.0 g/dL) at enrolment
iv.Known allergy or previous adverse reaction to any of the study drugs
v.Unable to give informed consent (for example due to mental disability)
vi.Previous inclusion in the same study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Active or recent placental malaria
- Secondary Outcome Measures
Name Time Method ¿Incidence of malaria infection and clinical malaria during pregnancy, defined as fever or recent history of fever in the presence of malaria parasites; ¿Prevalence of adverse newborn morbidity at birth, defined as a composite of either preterm delivery (<37 weeks¿ gestation), low birth weight (<2500 g), and, anemia (hemoglobin<11 g/dL) during pregnancy or at delivery