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

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: Not yet recruiting
• Conditions: Labor (Obstetrics)--Complications; Neonatal Complication
• Intervention / Treatment: Other: WHOs Labour care guide

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

• Study Contact: Name: Marie Blomberg, Professor; Phone Number: +4613288956; Email: marie.blomberg@liu.se
• Study Contact Backup: Name: Anna Ramö Isgren, pHD; Email: anna.ramo.isgren@regionostergotland.se

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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	The rate of intrapartum cesarean section	12 weeks up to 18 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal outcomes	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	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)	interviews questionaries	12 weeks up to 18 months
Provider experience of LCG	interviews	12 weeks up to 18 months
Economic evaluation	Data on health care utilization for women Data on health care utilization for children	12 weeks up to 18 months

Collaborators and Investigators

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

Publications and helpful links

General Publications

• WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/
• Vogel JP, Comrie-Thomson L, Pingray V, Gadama L, Galadanci H, Goudar S, Laisser R, Lavender T, Lissauer D, Misra S, Pujar Y, Qureshi ZP, Amole T, Berrueta M, Dankishiya F, Gwako G, Homer CSE, Jobanputra J, Meja S, Nigri C, Mohaptra V, Osoti A, Roberti J, Solomon D, Suleiman M, Robbers G, Sutherland S, Vernekar S, Althabe F, Bonet M, Oladapo OT. Usability, acceptability, and feasibility of the World Health Organization Labour Care Guide: A mixed-methods, multicountry evaluation. Birth. 2021 Mar;48(1):66-75. doi: 10.1111/birt.12511. Epub 2020 Nov 22.

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 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 (Estimated): October 9, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: neonatal outcomes; obstetric outcomes; labour care guide
• 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