Scheduled screening versus preventative treatment for the control of malaria in pregnancy in Malawi: a randomised controlled trial

Not Applicable

Completed

• Conditions: Malaria; Pregnancy and Childbirth

• Registration Number: PACTR201103000280319
• Lead Sponsor: iverpool School of Tropical Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-03-14
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 1656

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified