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

Not Applicable

Recruiting

• Conditions: Neonatal Complication; Labor (Obstetrics)--Complications

• Registration Number: NCT05560802
• Lead Sponsor: Linkoeping University

Brief 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.

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 Timeline

• Study First Submitted: 2022-09-17
• Study First Submitted QC: 2022-09-27
• Study First Posted: 2022-09-29
• Study Start: 2023-11-15
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-19
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-09
• Study Completion: 2027-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 120000

Inclusion Criteria

-All women in active labor

Exclusion Criteria

-No exclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The rate of intrapartum cesarean section	12 weeks up to 18 months	The rate of intrapartum cesarean section
Adverse neonatal outcome	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.

Secondary Outcome Measures

Name	Time	Method
Neonatal outcomes	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
Obstetric outcomes	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
Childbirth experience (women and partners)	12 weeks up to 18 months	interviews questionaries
Economic evaluation	12 weeks up to 18 months	Data on health care utilization for women Data on health care utilization for children
Provider experience of LCG	12 weeks up to 18 months	interviews

Trial Locations

Locations (24)

Eksjö höglandssjukhuset; 🇸🇪 Eksjö, Sweden

Falu Lasarett; 🇸🇪 Falun, Sweden

Gällivare sjukhus; 🇸🇪 Gällivare, Sweden

Göteborg Salgrenska Universitetssjukhuset; 🇸🇪 Göteborg, Sweden

Helsingborgs lasarett; 🇸🇪 Helsingborg, Sweden

Huddinge Karolinska universitetssjukhus; 🇸🇪 Huddinge, Sweden

Hudiksvalls sjukhus; 🇸🇪 Hudiksvall, Sweden

Jönköping Länssjukhuset Ryhov; 🇸🇪 Jönköping, Sweden

Länssjukhuset; 🇸🇪 Kalmar, Sweden

Kristianstad centralsjukhus; 🇸🇪 Kristianstad, Sweden

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