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

October 19, 2024 updated by: Marie Blomberg, Linkoeping University

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)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Estimated)

120000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Eksjö, Sweden
        • Recruiting
        • Eksjö höglandssjukhuset
        • Contact:
          • Emma Lindqvist
      • Falun, Sweden
        • Recruiting
        • Falu Lasarett
        • Contact:
          • Emma Åkerlund
      • Gällivare, Sweden
        • Recruiting
        • Gällivare sjukhus
        • Contact:
          • Malin Strand
      • Göteborg, Sweden
        • Recruiting
        • Göteborg Salgrenska Universitetssjukhuset
        • Contact:
          • Radha Korsoski
      • Helsingborg, Sweden
        • Recruiting
        • Helsingborgs Lasarett
        • Contact:
          • Tony Lavesson
      • Huddinge, Sweden
        • Recruiting
        • Huddinge Karolinska universitetssjukhus
        • Contact:
          • Cecilia Johansson
      • Hudiksvall, Sweden
        • Recruiting
        • Hudiksvalls sjukhus
        • Contact:
          • Zoltan Zavaczki
      • Jönköping, Sweden
        • Recruiting
        • Jönköping Länssjukhuset Ryhov
        • Contact:
          • Maria Wärnsberg
      • Kalmar, Sweden
        • Recruiting
        • Länssjukhuset
        • Contact:
          • Maria Svenvik
      • Kristianstad, Sweden
        • Recruiting
        • Kristianstad centralsjukhus
        • Contact:
          • Christina Vallen
      • Linköping, Sweden
        • Recruiting
        • Linkopings Universitetssjukhus
        • Contact:
          • Eric Hildebrand
      • Lund, Sweden
        • Recruiting
        • Lund Skånes universitetssjukhus
        • Contact:
          • Anna Bonnevier
      • Skellefteå, Sweden
        • Recruiting
        • Skellefteå lasarett
        • Contact:
          • Caisa Söderholm Edström
      • Stockholm, Sweden
        • Recruiting
        • BB Stockholm
        • Contact:
          • Katarina Remaeus
      • Stockholm, Sweden
        • Recruiting
        • Stockholm Södersjukhuset
        • Contact:
          • Hanna Åmark
      • Södertälje, Sweden
        • Recruiting
        • Södertälje Sjukhus
        • Contact:
          • Malin Öndemark
      • Södra Sunderbyn, Sweden
        • Recruiting
        • Sunderby Sjukhus
        • Contact:
          • Malin Strand
      • Umeå, Sweden
        • Recruiting
        • Umeå Norrlands universitetssjukhus
        • Contact:
          • Linnea Åström
      • Uppsala, Sweden
        • Recruiting
        • Akademiska sjukhuset
        • Contact:
          • Mariella Öberg
      • Visby, Sweden
        • Recruiting
        • Visby Lasarett
        • Contact:
          • Åsa Hedqvist
      • Värnamo, Sweden
        • Recruiting
        • Värnamo sjukhus
        • Contact:
          • Elin Boozon
      • Västervik, Sweden
        • Recruiting
        • Västerviks sjukhus
        • Contact:
          • Maria Källman
      • Ystad, Sweden
        • Recruiting
        • Ystad Lasarett
        • Contact:
          • Marie Carlsson
    • Östergötland
      • Norrkoping, Östergötland, Sweden
        • Recruiting
        • Vrinnevisjukhuset
        • Contact:
          • Ulrica Ottosson

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

-All women in active labor

Exclusion Criteria:

-No exclusion criteria

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Labour care guide
According to WHO guidelines
Other: WHOs Labour care guide
Guidelines for monitoring labor progress, the WHOs LCG
No Intervention: Standard care
Standard delivery care in Sweden

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse neonatal outcome
Time Frame: 12 weeks up to 18 months
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.
12 weeks up to 18 months
The rate of intrapartum cesarean section
Time Frame: 12 weeks up to 18 months
The rate of intrapartum cesarean section
12 weeks up to 18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neonatal outcomes
Time Frame: 12 weeks up to 18 months

Five-minute Apgar score <7

admission to neonatal unit

Hypoxic ischemic encephalopathy II-III

Intracranial hemorrhage

Neonatal seizures

Meconium aspiration syndrome

Five-minute Apgar score <4

Perinatal mortality

neonatal mortality

Neonatal infection

Neonatal hypoglycemia

Neonatal jaundice

Shoulder dystocia

Obstetric brachial plexus injury
12 weeks up to 18 months
Obstetric outcomes
Time Frame: 12 weeks up to 18 months

Rates of spontaneous vaginal delivery

Rates of instrumental delivery

Indications for intrapartum cesarean section

Rates of oxytocin use for augmentation of labor

Cervical dilation at onset of augmentation (centimeters)

Rates of adherence to oxytocin use recommendations

Rates of epidural use

Amount of postpartum bleeding, ml

Rates of perineal laceration (grade II-IV)

Duration of labor, minutes
12 weeks up to 18 months
Childbirth experience (women and partners)
Time Frame: 12 weeks up to 18 months
interviews questionaries
12 weeks up to 18 months
Provider experience of LCG
Time Frame: 12 weeks up to 18 months
interviews
12 weeks up to 18 months
Economic evaluation
Time Frame: 12 weeks up to 18 months
Data on health care utilization for women Data on health care utilization for children
12 weeks up to 18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Linkoeping University

Collaborators

The Swedish Research Council

Investigators

  • Principal Investigator: Marie Blomberg, Professor, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 15, 2023

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 1, 2027

Study Registration Dates

First Submitted

September 17, 2022

First Submitted That Met QC Criteria

September 27, 2022

First Posted (Actual)

September 29, 2022

Study Record Updates

Last Update Posted (Actual)

October 22, 2024

Last Update Submitted That Met QC Criteria

October 19, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Picrino2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At present we are not allowed to share anonymized data extracted from Swedish medical health registers

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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