Can the Use of a Next Generation Partograph Improve Neonatal Outcomes? (PICRINO)
NCT ID: NCT05560802
Last Updated: 2024-10-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
120000 participants
INTERVENTIONAL
2023-11-15
2027-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of Placental Drainage in the Third Stage of Labor: a Randomized Clinical Trial
NCT01655576
Prospective Evaluation of Pathways for Preterm Birth
NCT05246579
Cervical Cerclage for Preventing Spontaneous Preterm Birth in Singleton Pregnancies Without Prior Spontaneous Preterm Birth and With Short Transvaginal Ultrasound Cervical Length
NCT02746900
Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline
NCT02115256
Prevention of Recurrent Preterm Delivery by a Natural Progesterone Agent
NCT00329316
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Labour care guide
According to WHO guidelines
WHOs Labour care guide
Guidelines for monitoring labor progress, the WHOs LCG
Standard care
Standard delivery care in Sweden
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
WHOs Labour care guide
Guidelines for monitoring labor progress, the WHOs LCG
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Swedish Research Council
OTHER_GOV
Linkoeping University
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Marie Blomberg
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Marie Blomberg, Professor
Role: PRINCIPAL_INVESTIGATOR
Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Eksjö höglandssjukhuset
Eksjö, , Sweden
Falu Lasarett
Falun, , Sweden
Gällivare sjukhus
Gällivare, , Sweden
Göteborg Salgrenska Universitetssjukhuset
Gothenburg, , 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
Linköpings universitetssjukhus
Linköping, , Sweden
Lund Skånes universitetssjukhus
Lund, , Sweden
Skellefteå Lasarett
Skellefteå, , Sweden
Södertälje Sjukhus
Södertälje, , Sweden
Sunderby sjukhus
Södra Sunderbyn, , Sweden
BB Stockholm
Stockholm, , Sweden
Stockholm Södersjukhuset
Stockholm, , Sweden
Umeå Norrlands universitetssjukhus
Umeå, , Sweden
Akademiska sjukhuset
Uppsala, , Sweden
Värnamo sjukhus
Värnamo, , Sweden
Västerviks sjukhus
Västervik, , Sweden
Visby Lasarett
Visby, , Sweden
Ystad Lasarett
Ystad, , Sweden
Vrinnevisjukhuset
Norrköping, Östergötland County, Sweden
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Emma Lindqvist
Role: primary
Emma Åkerlund
Role: primary
Malin Strand
Role: primary
Radha Korsoski
Role: primary
Tony Lavesson
Role: primary
Cecilia Johansson
Role: primary
Zoltan Zavaczki
Role: primary
Maria Wärnsberg
Role: primary
Maria Svenvik
Role: primary
Christina Vallen
Role: primary
Eric Hildebrand
Role: primary
Anna Bonnevier
Role: primary
Caisa Söderholm Edström
Role: primary
Malin Öndemark
Role: primary
Malin Strand
Role: primary
Katarina Remaeus
Role: primary
Hanna Åmark
Role: primary
Linnea Åström
Role: primary
Mariella Öberg
Role: primary
Elin Boozon
Role: primary
Maria Källman
Role: primary
Åsa Hedqvist
Role: primary
Marie Carlsson
Role: primary
Ulrica Ottosson
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
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.
Isgren AR, Korsoski R, Abrahamsson T, Wendel SB, Kallen K, Lundborg L, Remaeus K, Thomas K, Wikstrom AK, Carlsson Y, Blomberg M. Can the use of a next generation partograph based on WHO's latest intrapartum care recommendations improve neonatal outcomes? (PICRINO) Study protocol for a stepped-wedge cluster randomized trial. PLoS One. 2025 Mar 4;20(3):e0316336. doi: 10.1371/journal.pone.0316336. eCollection 2025.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
Picrino2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.