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

Labor (Obstetrics)--Complications Clinical Trial

Official 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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05560802
• Other study ID #: Picrino2022
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 2023
• Est. completion date: September 2027

Study information

• Verified date: October 2023
• Source: Linkoeping University
• Contact: Marie Blomberg, Professor
• Phone: +4613288956
• Email: marie.blomberg[@]liu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120000
• Est. completion date: September 2027
• Est. primary completion date: September 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

-All women in active labor

Exclusion Criteria:

-No exclusion criteria

Related Conditions & MeSH terms

• Labor (Obstetrics)--Complications

Intervention

Other:
• WHOs Labour care guide
Guidelines for monitoring labor progress, the WHOs LCG

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Linkoeping University

References & Publications (2)

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, — View Citation

WHO recommendations: Intrapartum care for a positive childbirth experience. Geneva: World Health Organization; 2018. Available from http://www.ncbi.nlm.nih.gov/books/NBK513809/ — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	The rate of intrapartum cesarean section	The rate of intrapartum cesarean section	12 weeks up to 18 months
Secondary	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
Secondary	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
Secondary	Childbirth experience (women and partners)	interviews questionaries	12 weeks up to 18 months
Secondary	Provider experience of LCG	interviews	12 weeks up to 18 months
Secondary	Economic evaluation	Data on health care utilization for women Data on health care utilization for children	12 weeks up to 18 months