NCT05560802

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

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)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120,000 (estimated)
• Sponsor: Linkoeping University · Other Government
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Neonatal Complication
• Labor (Obstetrics)--Complications

Interventions

Type	Name	Description
OTHER	WHOs Labour care guide	Guidelines for monitoring labor progress, the WHOs LCG

Timeline

• Start date: 2023-11-15
• Primary completion: 2025-09-01
• Completion: 2027-09-01
• First posted: 2022-09-29
• Last updated: 2024-10-22

Locations

24 sites across 1 country: Sweden