Kan het gebruik van een Partograph van de volgende generatie de neonatale uitkomsten verbeteren? (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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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
Studietype
Inschrijving (Geschat)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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-
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Eksjö, Zweden
- Eksjö höglandssjukhuset
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Falun, Zweden
- Falu Lasarett
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Gothenburg, Zweden
- Göteborg Salgrenska Universitetssjukhuset
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Gällivare, Zweden
- Gällivare sjukhus
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Helsingborg, Zweden
- Helsingborgs lasarett
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Huddinge, Zweden
- Huddinge Karolinska universitetssjukhus
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Hudiksvall, Zweden
- Hudiksvalls sjukhus
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Jönköping, Zweden
- Jönköping Länssjukhuset Ryhov
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Kalmar, Zweden
- Länssjukhuset
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Kristianstad, Zweden
- Kristianstad centralsjukhus
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Linköping, Zweden
- Linköpings universitetssjukhus
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Lund, Zweden
- Lund Skånes universitetssjukhus
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Skellefteå, Zweden
- Skellefteå Lasarett
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Stockholm, Zweden
- BB Stockholm
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Stockholm, Zweden
- Stockholm Södersjukhuset
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Södertälje, Zweden
- Södertälje Sjukhus
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Södra Sunderbyn, Zweden
- Sunderby sjukhus
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Umeå, Zweden
- Umeå Norrlands universitetssjukhus
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Uppsala, Zweden
- Akademiska sjukhuset
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Visby, Zweden
- Visby Lasarett
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Värnamo, Zweden
- Värnamo sjukhus
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Västervik, Zweden
- Västerviks sjukhus
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Ystad, Zweden
- Ystad Lasarett
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Östergötland County
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Norrköping, Östergötland County, Zweden
- Vrinnevisjukhuset
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
-All women in active labor
Exclusion Criteria:
-No exclusion criteria
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: Labour care guide
According to WHO guidelines |
Guidelines for monitoring labor progress, the WHOs LCG |
|
Geen tussenkomst: Standard care
Standard delivery care in Sweden |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Adverse neonatal outcome
Tijdsspanne: 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. |
12 weeks up to 18 months
|
|
The rate of intrapartum cesarean section
Tijdsspanne: 12 weeks up to 18 months
|
The rate of intrapartum cesarean section |
12 weeks up to 18 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Neonatal outcomes
Tijdsspanne: 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 |
12 weeks up to 18 months
|
|
Obstetric outcomes
Tijdsspanne: 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 |
12 weeks up to 18 months
|
|
Childbirth experience (women and partners)
Tijdsspanne: 12 weeks up to 18 months
|
interviews questionaries |
12 weeks up to 18 months
|
|
Provider experience of LCG
Tijdsspanne: 12 weeks up to 18 months
|
interviews |
12 weeks up to 18 months
|
|
Economic evaluation
Tijdsspanne: 12 weeks up to 18 months
|
Data on health care utilization for women Data on health care utilization for children |
12 weeks up to 18 months
|
Medewerkers en onderzoekers
Sponsor
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Marie Blomberg, Professor, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Publicaties en nuttige links
Algemene publicaties
- 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.
- Sjoberg J, Ramo Isgren A, Abrahamsson T, Blomberg M, Thomas K. Associations between organizational readiness and implementation fidelity in national implementation of WHO's labour care guide in Sweden: a prospective observational study. Implement Sci Commun. 2026 Aug 14;7(1):165. doi: 10.1186/s43058-026-01073-z.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Geschat)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
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Meer informatie
Termen gerelateerd aan deze studie
Andere studie-ID-nummers
- Picrino2022
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
At present we are not allowed to share anonymized data extracted from Swedish medical health registers
Informatie over medicijnen en apparaten, studiedocumenten
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