PACTR201103000280319Completed未知
Scheduled intermittent screening and treatment in pregnancy (ISTp) versus intermittent preventive treatment with sulphadoxine-pyrimethamine (IPTp-SP) in women protected by insecticide treated nets (ITNs) for the control of malaria in pregnancy in Malawi: a randomized controlled trial
iverpool School of Tropical Medicine0 sites1,656 target enrollmentStarted: March 14, 2011Last updated:
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Completed
- Sponsor
- Enrollment
- 1,656
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 16 Year(s) to 40 Year(s) (—)
- Sex
- Female
Inclusion Criteria
- •1.Viable singleton pregnancy
- •2.Gestational age 16 to 28 weeks (inclusive) by LMP (if available) or fundal height
- •3.No history of IPTp use during this pregnancy
- •4.Willing to participate and complete the study schedule
- •5.Has provided written informed consent
- •6.Resident of study area and intending to stay in the area for the duration of the follow-up
- •7.Willing to deliver in the labour ward of the study clinic or hospital
Exclusion Criteria
- •1.HIV positive or unknown HIV status
- •2.Multiple gestations
- •3.High risk pregnancy resulting in referral to tertiary delivery facilities according to local guidelines, these include:
- •a.Age under 16 or over 40
- •b.Five or more previous pregnancies
- •c.Pre-existing illness likely to cause complication of pregnancy (hypertension, diabetes, asthma, epilepsy, renal disease, fistula repair, leg or spine deformity)
- •d.Two or more previous miscarriages or induced abortions
- •e.Previous caesarian section delivery, vacuum extraction or symphysiotomy
- •f.History of pregnancy or birth complications (pre-eclampsia or post-partum haemorrhage)
- •4.Severe anaemia requiring blood transfusion (Hb ¿ 7.0 g/dL) at enrolment
- •5.Known allergy or previous adverse reaction to any of the study drugs
- •6.Unable to give informed consent (for example due to mental disability)
- •7.Previous inclusion in the same study
Investigators
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