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

Официальное название

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)

Обзор

The overall aim is to evaluate the impact of the use of two different guidelines for monitoring labor progress, the WHOs LCG versus standard care, on neonatal and maternal outcomes. The hypothesis is that the use of LCG will reduce adverse neonatal outcomes and decrease the number of intrapartum Cesarean sections compared with standard care. Secondly, other perinatal interventions and complications will be compared between the LCG and standard care groups, as well as economic considerations. This will be investigated using a multicenter, stepped-wedge cluster randomized trial design. In addition, the project will explore a series of quantitative and qualitative research questions to gain in-depth knowledge about experiences and perceptions about childbirth and the use of LCG. These research questions will be investigated using questionnaires, focus group and individual interviews with providers, partners and women that have gone through childbirth.

Подробное описание

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

Вмешательства

• Другое WHOs Labour care guide
  Guidelines for monitoring labor progress, the WHOs LCG

Первичные конечные точки

• Adverse neonatal outcome [Срок оценки: 12 weeks up to 18 months]
• The rate of intrapartum cesarean section [Срок оценки: 12 weeks up to 18 months]

Вторичные конечные точки (5)

• Neonatal outcomes [Срок оценки: 12 weeks up to 18 months]
• Obstetric outcomes [Срок оценки: 12 weeks up to 18 months]
• Childbirth experience (women and partners) [Срок оценки: 12 weeks up to 18 months]
• Provider experience of LCG [Срок оценки: 12 weeks up to 18 months]
• Economic evaluation [Срок оценки: 12 weeks up to 18 months]

Критерии участия

Критерии включения

-All women in active labor

Критерии исключения

-No exclusion criteria

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Швеция · 24 центра

• Eksjö höglandssjukhuset — Eksjö
• Falu Lasarett — Falun
• Gällivare sjukhus — Gällivare
• Göteborg Salgrenska Universitetssjukhuset — Gothenburg
• Helsingborgs lasarett — Helsingborg
• Huddinge Karolinska universitetssjukhus — Huddinge
• Hudiksvalls sjukhus — Hudiksvall
• Jönköping Länssjukhuset Ryhov — Jönköping
• … и ещё 16 центров

Публикации

• WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/ PMID 30070803
• Vogel JP, Comrie-Thomson L, Pingray V, Gadama L, Galadanci H, Goudar S, Laisser R, Lavender T, Lissauer D, Misra S, Pujar Y, Qureshi ZP, Amole T, Berrueta M, Dankishiya F, Gwako G, Homer CSE, Jobanputra J, Meja S, Nigri C, Mohaptra V, Osoti A, Roberti J, Solomon D, Suleiman M, Robbers G, Sutherland S, Vernekar S, Althabe F, Bonet M, Oladapo OT. Usability, acceptability, and feasibility of the Worl PMID 33225484
• Isgren AR, Korsoski R, Abrahamsson T, Wendel SB, Kallen K, Lundborg L, Remaeus K, Thomas K, Wikstrom AK, Carlsson Y, Blomberg M. Can the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? (PICRINO) Study protocol for a stepped-wedge cluster randomized trial. PLoS One. 2025 Mar 4;20(3):e0316336. doi: 10.1371/journal.pone.0316336. eC PMID 40036215

Идентификаторы

NCT: NCT05560802 · Picrino2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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