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

NCT05560802 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 120000

Last updated 2024-10-22

No results posted yet for this study

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.

Conditions

  • Neonatal Complication
  • Labor (Obstetrics)--Complications

Interventions

OTHER

WHOs Labour care guide

Guidelines for monitoring labor progress, the WHOs LCG

Sponsors & Collaborators

  • The Swedish Research Council

    collaborator OTHER_GOV

  • Linkoeping University

    lead OTHER_GOV

Principal Investigators

  • Marie Blomberg, Professor · Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-11-15
Primary Completion
2025-09-30
Completion
2027-09-30

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05560802 on ClinicalTrials.gov