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  • Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)

    Study Title Can the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? A stepped-wedge cluster randomized trial (PICRINO). Primary Objectives To compare two different guidelines for monitoring labor progress, the the World Health Organization (WHO)'s Labour Care Guide (LCG) with standard care, and evaluate: Adverse neonatal outcome, a composite outcome of perinatal mortality and neonatal morbidity. Neonatal morbidity will include five-minute Apgar score <7, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures, meconium aspiration syndrome, and admission to a neonatal unit. The rate of intrapartum cesarean section. Secondary Objectives Secondary outcomes will be a composite of severe neonatal outcomes including five-minute Apgar score <4, hypoxic ischemic encephalopathy II-III, intracranial hemorrhage, neonatal seizures and meconium aspiration syndrome and other relevant neonatal outcomes. Obstetric outcomes will be mode of delivery, oxytocin use, postpartum hemorrhage, perineal laceration (grade II-IV), duration of labor, women´s and partner´s experiences of childbirth, healthcare providers experiences of and compliance to LCG and economic considerations. Study Design A multicenter, stepped-wedge cluster randomized trial. Study Population All women in active labor at participating delivery units in Sweden. Power analysis With significance level 0.05, the power to detect the anticipated risk reduction (20%) would be >0.999. Study Duration 2023-2025

    Phase

    N/A

    Span

    203 weeks

    Sponsor

    Linkoeping University

    Norrkoping, Östergötland

    Recruiting

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