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NCT Number: NCT05560802

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

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Key information

Conditions

Neonatal Complication Labor (Obstetrics)--Complications

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Vrinnevisjukhuset, Norrköping, Östergötland County, Sweden

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-All women in active labor

Exclusion criteria

-No exclusion criteria

Treatment and study plan

WHOs Labour care guide

Other

Guidelines for monitoring labor progress, the WHOs LCG

Primary outcomes

  1. 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.

  2. The rate of intrapartum cesarean section

    Time frame: 12 weeks up to 18 months

    The rate of intrapartum cesarean section

Secondary outcomes

  1. 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

  2. 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

  3. Childbirth experience (women and partners)

    Time frame: 12 weeks up to 18 months

    interviews questionaries

  4. Provider experience of LCG

    Time frame: 12 weeks up to 18 months

    interviews

  5. Economic evaluation

    Time frame: 12 weeks up to 18 months

    Data on health care utilization for women Data on health care utilization for children

Study contacts

Contact information is provided by the study sponsor or research team.

Anna Ramö Isgren, pHD

CONTACT

[email protected]

Marie Blomberg, Professor

CONTACT

[email protected]

+4613288956

Sponsors and collaborators

Lead sponsor

Linkoeping University

Other Gov

Collaborators

  • The Swedish Research Council

Registry information

Official 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)

Important dates

Study start
2023
Primary completion
2025
Study completion
2027
First posted
Sep 29, 2022
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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