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Neonatal ComplicationNCT05560802

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

A study testing WHOs Labour care guide in people with Neonatal Complication and Labor (Obstetrics)--Complications, run by Linkoeping University at 24 sites in Sweden.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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. Read more about this study

Who is it for?
Any age, women only
What is being tested?
WHOs Labour care guide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120,000 participants
Where
24 sitesSweden
Study dates
15 Nov 2023to Sep 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • -All women in active labor

Who cannot join

  • -No exclusion criteria

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Marie Blomberg, Professor contact

+4613288956

marie.blomberg@liu.se

Anna Ramö Isgren, pHD contact

anna.ramo.isgren@regionostergotland.se

24 sites in 1 country

Sweden24 sites, 24 recruiting

  • Eksjö höglandssjukhuset

    Eksjö

    Emma Lindqvist

    Recruiting

  • Falu Lasarett

    Falun

    Emma Åkerlund

    Recruiting

  • Gällivare sjukhus

    Gällivare

    Malin Strand

    Recruiting

  • Göteborg Salgrenska Universitetssjukhuset

    Gothenburg

    Radha Korsoski

    Recruiting

  • Helsingborgs lasarett

    Helsingborg

    Tony Lavesson

    Recruiting

  • Huddinge Karolinska universitetssjukhus

    Huddinge

    Cecilia Johansson

    Recruiting

  • Hudiksvalls sjukhus

    Hudiksvall

    Zoltan Zavaczki

    Recruiting

  • Jönköping Länssjukhuset Ryhov

    Jönköping

    Maria Wärnsberg

    Recruiting

  • Länssjukhuset

    Kalmar

    Maria Svenvik

    Recruiting

  • Kristianstad centralsjukhus

    Kristianstad

    Christina Vallen

    Recruiting

  • Linköpings universitetssjukhus

    Linköping

    Eric Hildebrand

    Recruiting

  • Lund Skånes universitetssjukhus

    Lund

    Anna Bonnevier

    Recruiting

  • Vrinnevisjukhuset

    Norrköping, Östergötland County

    Ulrica Ottosson

    Recruiting

  • Skellefteå Lasarett

    Skellefteå

    Caisa Söderholm Edström

    Recruiting

  • Södertälje Sjukhus

    Södertälje

    Malin Öndemark

    Recruiting

  • Sunderby sjukhus

    Södra Sunderbyn

    Malin Strand

    Recruiting

  • BB Stockholm

    Stockholm

    Katarina Remaeus

    Recruiting

  • Stockholm Södersjukhuset

    Stockholm

    Hanna Åmark

    Recruiting

  • Umeå Norrlands universitetssjukhus

    Umeå

    Linnea Åström

    Recruiting

  • Akademiska sjukhuset

    Uppsala

    Mariella Öberg

    Recruiting

  • Värnamo sjukhus

    Värnamo

    Elin Boozon

    Recruiting

  • Västerviks sjukhus

    Västervik

    Maria Källman

    Recruiting

  • Visby Lasarett

    Visby

    Åsa Hedqvist

    Recruiting

  • Ystad Lasarett

    Ystad

    Marie Carlsson

    Recruiting

Other trials in Sweden

About this study

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)

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.

Read the 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

Being tested
WHOs Labour care guide
Keywords
neonatal outcomes, obstetric outcomes, labour care guide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • WHOs Labour care guideOther

    Guidelines for monitoring labor progress, the WHOs LCG

Study groups in NCT05560802
Study groupRoleWhat they receive
Labour care guideExperimentalAccording to WHO guidelines
Receives: Other: WHOs Labour care guide
Standard careNo interventionStandard delivery care in Sweden

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks up to 18 months

  2. The rate of intrapartum cesarean section

    The rate of intrapartum cesarean section

    Measured: 12 weeks up to 18 months

Secondary outcomes (5)

  1. 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

    Measured: 12 weeks up to 18 months

  2. 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

    Measured: 12 weeks up to 18 months

  3. Childbirth experience (women and partners)

    interviews questionaries

    Measured: 12 weeks up to 18 months

  4. Provider experience of LCG

    interviews

    Measured: 12 weeks up to 18 months

  5. Economic evaluation

    Data on health care utilization for women Data on health care utilization for children

    Measured: 12 weeks up to 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Sep 2022
  2. Study start15 Nov 2023
  3. Primary completionSep 2025 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
multicenter, stepped-wedge cluster randomized trial
Masking
None (open label)
Enrolment
120,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05560802
Sponsor's protocol ID
Picrino2022
Status last verified
Oct 2024
First submitted
17 Sep 2022
Last updated
22 Oct 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: At present we are not allowed to share anonymized data extracted from Swedish medical health registers

Publications

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

    PubMed 30070803

  • 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.

    PubMed 33225484

  • 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.

    PubMed 42638149

  • 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.

    PubMed 40036215

Questions about this trial

What is this clinical trial studying?

A study testing WHOs Labour care guide in people with Neonatal Complication and Labor (Obstetrics)--Complications, run by Linkoeping University at 24 sites in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Marie Blomberg, Professor (+4613288956, marie.blomberg@liu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse neonatal outcome (time frame: 12 weeks up to 18 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05560802, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2024.

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