Clinical trial NCT05560802: Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)
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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neonatal Complication
Labor (Obstetrics)--Complications
Keywords: neonatal outcomes
obstetric outcomes
labour care guide
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: The Swedish Research Council
First posted: 2022-09-29
Enrollment: 120000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, stepped-wedge cluster randomized trial
Primary purpose: TREATMENT

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

Eligibility criteria: Inclusion Criteria:

-All women in active labor

Exclusion Criteria:

-No exclusion criteria

Primary outcomes:
measure: Adverse neonatal outcome
timeFrame: 12 weeks up to 18 months
measure: The rate of intrapartum cesarean section
timeFrame: 12 weeks up to 18 months
Secondary outcomes:
measure: Neonatal outcomes
timeFrame: 12 weeks up to 18 months
measure: Obstetric outcomes
timeFrame: 12 weeks up to 18 months
measure: Childbirth experience (women and partners)
timeFrame: 12 weeks up to 18 months
measure: Provider experience of LCG
timeFrame: 12 weeks up to 18 months
measure: Economic evaluation
timeFrame: 12 weeks up to 18 months
Other outcomes:
Locations:
city: Eksjö
country: Sweden
facility: Eksjö höglandssjukhuset
city: Falun
country: Sweden
facility: Falu Lasarett
city: Gällivare
country: Sweden
facility: Gällivare sjukhus
city: Göteborg
country: Sweden
facility: Göteborg Salgrenska Universitetssjukhuset
city: Helsingborg
country: Sweden
facility: Helsingborgs lasarett
city: Huddinge
country: Sweden
facility: Huddinge Karolinska universitetssjukhus
city: Hudiksvall
country: Sweden
facility: Hudiksvalls sjukhus
city: Jönköping
country: Sweden
facility: Jönköping Länssjukhuset Ryhov
city: Kalmar
country: Sweden
facility: Länssjukhuset
city: Kristianstad
country: Sweden
facility: Kristianstad centralsjukhus
city: Linköping
country: Sweden
facility: Linköpings universitetssjukhus
city: Lund
country: Sweden
facility: Lund Skånes universitetssjukhus
city: Skellefteå
country: Sweden
facility: Skellefteå Lasarett
city: Stockholm
country: Sweden
facility: BB Stockholm
city: Stockholm
country: Sweden
facility: Stockholm Södersjukhuset
city: Södertälje
country: Sweden
facility: Södertälje Sjukhus
city: Södra Sunderbyn
country: Sweden
facility: Sunderby sjukhus
city: Umeå
country: Sweden
facility: Umeå Norrlands universitetssjukhus
city: Uppsala
country: Sweden
facility: Akademiska sjukhuset
city: Visby
country: Sweden
facility: Visby Lasarett
city: Värnamo
country: Sweden
facility: Värnamo sjukhus
city: Västervik
country: Sweden
facility: Västerviks sjukhus
city: Ystad
country: Sweden
facility: Ystad Lasarett
city: Norrkoping
country: Sweden
facility: Vrinnevisjukhuset
state: Östergötland
Study officials:
affiliation: Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
name: Marie Blomberg, Professor
role: PRINCIPAL_INVESTIGATOR
References:
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/
citation: 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.