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

Not Applicable

Completed

• Conditions: Control of malaria in pregnancy; Infections and Infestations; Malaria

• Registration Number: ISRCTN69800930
• Lead Sponsor: iverpool School of Tropical Medicine (UK)

Brief Summary

2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27622558 2019 nested study results in: https://www.ncbi.nlm.nih.gov/pubmed/31133672 (added 29/05/2019) 2020 results in https://pubmed.ncbi.nlm.nih.gov/32221555 (added 30/03/2020)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-04-07
• Study Completion: 2013-11-01
• Last Update Posted: 20 April 2020

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 1873

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
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

Primary Outcome Measures

Name	Time	Method
<br> 1. In women in their first or second pregnancy: composite endpoint of adverse birth outcomes, defined as any of:<br> 1.1. Small for gestational age defined as a binary outcome of <10th percentile of fetal weight for attained gestational age<br> 1.2. Preterm birth (spontaneous birth before 37 weeks gestation)<br> 1.3. Low-birth-weight (birth weight under 2,500 grams)<br> 2. In women in their third to fifth pregnancies: Malaria infection at term and delivery will be the primary endpoint, defined as evidence of current or recent infection assessed at delivery by placental histopathology (?active? or ?past? infection) or rapid diagnositc tests (RDT) (pLDH or HRP2 positive, any species) or PCR positive (any species)<br>