Kan bruken av en neste generasjons partograf forbedre neonatale resultater? (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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
-
Eksjö, Sverige
- Eksjö höglandssjukhuset
-
Falun, Sverige
- Falu Lasarett
-
Gothenburg, Sverige
- Göteborg Salgrenska Universitetssjukhuset
-
Gällivare, Sverige
- Gällivare sjukhus
-
Helsingborg, Sverige
- Helsingborgs lasarett
-
Huddinge, Sverige
- Huddinge Karolinska universitetssjukhus
-
Hudiksvall, Sverige
- Hudiksvalls sjukhus
-
Jönköping, Sverige
- Jönköping Länssjukhuset Ryhov
-
Kalmar, Sverige
- Länssjukhuset
-
Kristianstad, Sverige
- Kristianstad centralsjukhus
-
Linköping, Sverige
- Linköpings universitetssjukhus
-
Lund, Sverige
- Lund Skånes universitetssjukhus
-
Skellefteå, Sverige
- Skellefteå Lasarett
-
Stockholm, Sverige
- BB Stockholm
-
Stockholm, Sverige
- Stockholm Södersjukhuset
-
Södertälje, Sverige
- Södertälje Sjukhus
-
Södra Sunderbyn, Sverige
- Sunderby sjukhus
-
Umeå, Sverige
- Umeå Norrlands universitetssjukhus
-
Uppsala, Sverige
- Akademiska sjukhuset
-
Visby, Sverige
- Visby Lasarett
-
Värnamo, Sverige
- Värnamo sjukhus
-
Västervik, Sverige
- Västerviks sjukhus
-
Ystad, Sverige
- Ystad Lasarett
-
-
Östergötland County
-
Norrköping, Östergötland County, Sverige
- Vrinnevisjukhuset
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
-All women in active labor
Exclusion Criteria:
-No exclusion criteria
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Labour care guide
According to WHO guidelines |
Guidelines for monitoring labor progress, the WHOs LCG |
|
Ingen inngripen: Standard care
Standard delivery care in Sweden |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adverse neonatal outcome
Tidsramme: 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
Tidsramme: 12 weeks up to 18 months
|
The rate of intrapartum cesarean section |
12 weeks up to 18 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neonatal outcomes
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 12 weeks up to 18 months
|
interviews questionaries |
12 weeks up to 18 months
|
|
Provider experience of LCG
Tidsramme: 12 weeks up to 18 months
|
interviews |
12 weeks up to 18 months
|
|
Economic evaluation
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Marie Blomberg, Professor, Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- Picrino2022
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
At present we are not allowed to share anonymized data extracted from Swedish medical health registers
Legemiddel- og utstyrsinformasjon, studiedokumenter
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