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

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
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.

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 24 · Start date changed from estimate of Nov 2023 to Nov 15, 2023 · Publications: details revised at 2 of 4 entries · 1 morev3 Show 4 more changesShow less
    • Study sites: 0 to 24
    • Start date changed from estimate of Nov 2023 to Nov 15, 2023
    • Publications: details revised at 2 of 4 entries
    • Collaborators expanded, about 4 words

    See this version in full on ClinicalTrials.gov ↗

  2. Start date: Sep 2023 to Nov 2023v2
  3. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov