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

Last updated: October 19, 2024
Sponsor: Linkoeping University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

WHOs Labour care guide

Clinical Study ID

NCT05560802
Picrino2022
  • Female

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

-All women in active labor

Exclusion

Exclusion Criteria:

-No exclusion criteria

Study Design

Total Participants: 120000
Treatment Group(s): 1
Primary Treatment: WHOs Labour care guide
Phase:
Study Start date:
November 15, 2023
Estimated Completion Date:
September 30, 2027

Study 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

Connect with a study center

  • Vrinnevisjukhuset

    Norrkoping, Östergötland
    Sweden

    Active - Recruiting

  • Eksjö höglandssjukhuset

    Eksjö,
    Sweden

    Active - Recruiting

  • Falu Lasarett

    Falun,
    Sweden

    Active - Recruiting

  • Gällivare sjukhus

    Gällivare,
    Sweden

    Active - Recruiting

  • Göteborg Salgrenska Universitetssjukhuset

    Göteborg,
    Sweden

    Active - Recruiting

  • Helsingborgs lasarett

    Helsingborg,
    Sweden

    Active - Recruiting

  • Huddinge Karolinska universitetssjukhus

    Huddinge,
    Sweden

    Active - Recruiting

  • Hudiksvalls sjukhus

    Hudiksvall,
    Sweden

    Active - Recruiting

  • Jönköping Länssjukhuset Ryhov

    Jönköping,
    Sweden

    Active - Recruiting

  • Länssjukhuset

    Kalmar,
    Sweden

    Active - Recruiting

  • Kristianstad centralsjukhus

    Kristianstad,
    Sweden

    Active - Recruiting

  • Linköpings universitetssjukhus

    Linköping,
    Sweden

    Active - Recruiting

  • Lund Skånes universitetssjukhus

    Lund,
    Sweden

    Active - Recruiting

  • Skellefteå Lasarett

    Skellefteå,
    Sweden

    Active - Recruiting

  • BB Stockholm

    Stockholm,
    Sweden

    Active - Recruiting

  • Stockholm Södersjukhuset

    Stockholm,
    Sweden

    Active - Recruiting

  • Södertälje Sjukhus

    Södertälje,
    Sweden

    Active - Recruiting

  • Sunderby sjukhus

    Södra Sunderbyn,
    Sweden

    Active - Recruiting

  • Umeå Norrlands universitetssjukhus

    Umeå,
    Sweden

    Active - Recruiting

  • Akademiska sjukhuset

    Uppsala,
    Sweden

    Active - Recruiting

  • Visby Lasarett

    Visby,
    Sweden

    Active - Recruiting

  • Värnamo sjukhus

    Värnamo,
    Sweden

    Active - Recruiting

  • Västerviks sjukhus

    Västervik,
    Sweden

    Active - Recruiting

  • Ystad Lasarett

    Ystad,
    Sweden

    Active - Recruiting

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