Clinical Trial

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

Recruiting
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Record status
This record was last updated October 22, 2024 (before its estimated September 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 2 amendments
This ClinicalTrials.gov record has been amended 2 times since 2022-09-27; most recent amendment 2024-10-19.
Status change: Not Yet Recruiting → Recruiting 2024-10-19
Trial Details
NCT Number NCT05560802
Lead Sponsor Linkoeping University
Collaborators: The Swedish Research Council
Conditions Neonatal Complication, Labor (Obstetrics)--Complications
Enrollment 120,000 participants
Start Date 2023-11-15
Primary Completion 2025-09 (estimated)
Study Completion 2027-09 (estimated)
Updated on ClinicalTrials.gov 2024-10-22