SAINT Trial Raw Dataset

Version 1.0
Trond Melbye Michelsen, 2026, "SAINT Trial Raw Dataset", https://doi.org/10.18710/MG91J3, DataverseNO, V1
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Description
This dataset contains anonymised participant-level data from the Safe Induction of Labour Trial (SAINT), a multicentre, double-blind, randomised, placebo-controlled phase III clinical trial conducted at Norwegian hospitals. Participant recruitment and randomisation took place between 4 January 2023 and 29 January 2025. The study database was locked on 5 June 2025 following completion of data cleaning, query resolution, source data verification, and quality assurance procedures. The released dataset is anonymised and contains no information that can reasonably be used to identify individual participants. The dataset includes anonymised participant-level study data, statistical analysis files, open-format data files, and a complete data dictionary containing variable names, descriptions, data types, and units of measurement. Participating hospitals were Oslo University Hospital, Akershus University Hospital, Haukeland University Hospital, Stavanger University Hospital, St. Olavs Hospital, University Hospital of North Norway, Østfold Hospital Trust, Sørlandet Hospital, and Vestre Viken Hospital Trust. The study was funded by the Norwegian National Program for Clinical Treatment Research in the Specialist Health Services (KLINBEFORSK), Grant Number 2021205. Clinical trial registration: ClinicalTrials.gov NCT05719467; EudraCT 2021-000392-37; EU CT Number 2024-511848-55-00. (2026-08-25)
Subject Medicine, Health and Life Sciences
Keyword SAINT, Safe Induction of Labour Trial, induction of labor, labor induction, misoprostol, placebo, clinical trial, randomized controlled trial, phase III trial, obstetrics, pregnancy, childbirth, vaginal delivery, caesarean section, maternal outcomes, neonatal outcomes, Norway
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00_READEME 24AUG2026.txt
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Published Aug 25, 2026
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MD5: 8bd1c03c1907976de9504332f0c0a8dd
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5-Minute Apgar Score Below 7 - FA Set.dat
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Published Aug 25, 2026
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5-Minute Apgar Score Below 7 - FA Set.dta
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Published Aug 25, 2026
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5-Minute Apgar Score Below 7 - PP Set.dat
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Published Aug 25, 2026
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MD5: 9609a4762e4f7240188f4be07ecc3b8e
5-Minute Apgar Score Below 7 - PP Set.dta
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Published Aug 25, 2026
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Admission to the Neonatal Intensive Care Unit - FA Set.dat
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Published Aug 25, 2026
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Admission to the Neonatal Intensive Care Unit - FA Set.dta
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Published Aug 25, 2026
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Admission to the Neonatal Intensive Care Unit - PP Set.dat
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Published Aug 25, 2026
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MD5: 976a787748354b9fc8cb01441c3d8c5f
Admission to the Neonatal Intensive Care Unit - PP Set.dta
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Published Aug 25, 2026
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Mode of Delivery - FA Set.dat
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Published Aug 25, 2026
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MD5: 6972be489dc6b03172c0ad05b871afc6
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