NCT05560802

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120,000

participants targeted

Target at P75+ for not_applicable

Timeline
16mo left

Started Nov 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

24 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress65%
Nov 2023Sep 2027

First Submitted

Initial submission to the registry

September 17, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

September 29, 2022

Completed
1.1 years until next milestone

Study Start

First participant enrolled

November 15, 2023

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2027

Expected
Last Updated

October 22, 2024

Status Verified

October 1, 2024

Enrollment Period

1.8 years

First QC Date

September 17, 2022

Last Update Submit

October 19, 2024

Conditions

Neonatal ComplicationLabor (Obstetrics)--Complications

Keywords

neonatal outcomesobstetric outcomeslabour care guide

Outcome Measures

Primary Outcomes (2)

  • 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.

    12 weeks up to 18 months

  • The rate of intrapartum cesarean section

    The rate of intrapartum cesarean section

    12 weeks up to 18 months

Secondary Outcomes (5)

  • Neonatal outcomes

    12 weeks up to 18 months

  • Obstetric outcomes

    12 weeks up to 18 months

  • Childbirth experience (women and partners)

    12 weeks up to 18 months

  • Provider experience of LCG

    12 weeks up to 18 months

  • Economic evaluation

    12 weeks up to 18 months

Study Arms (2)

Labour care guide

EXPERIMENTAL

According to WHO guidelines

Other: WHOs Labour care guide

Standard care

NO INTERVENTION

Standard delivery care in Sweden

Interventions

WHOs Labour care guideOTHER

Guidelines for monitoring labor progress, the WHOs LCG

Labour care guide

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All women in active labor

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Eksjö höglandssjukhuset

Eksjö, Sweden

RECRUITING

Falu Lasarett

Falun, Sweden

RECRUITING

Gällivare sjukhus

Gällivare, Sweden

RECRUITING

Göteborg Salgrenska Universitetssjukhuset

Gothenburg, Sweden

RECRUITING

Helsingborgs lasarett

Helsingborg, Sweden

RECRUITING

Huddinge Karolinska universitetssjukhus

Huddinge, Sweden

RECRUITING

Hudiksvalls sjukhus

Hudiksvall, Sweden

RECRUITING

Jönköping Länssjukhuset Ryhov

Jönköping, Sweden

RECRUITING

Länssjukhuset

Kalmar, Sweden

RECRUITING

Kristianstad centralsjukhus

Kristianstad, Sweden

RECRUITING

Linköpings universitetssjukhus

Linköping, Sweden

RECRUITING

Lund Skånes universitetssjukhus

Lund, Sweden

RECRUITING

Skellefteå Lasarett

Skellefteå, Sweden

RECRUITING

Södertälje Sjukhus

Södertälje, Sweden

RECRUITING

Sunderby sjukhus

Södra Sunderbyn, Sweden

RECRUITING

BB Stockholm

Stockholm, Sweden

RECRUITING

Stockholm Södersjukhuset

Stockholm, Sweden

RECRUITING

Umeå Norrlands universitetssjukhus

Umeå, Sweden

RECRUITING

Akademiska sjukhuset

Uppsala, Sweden

RECRUITING

Värnamo sjukhus

Värnamo, Sweden

RECRUITING

Västerviks sjukhus

Västervik, Sweden

RECRUITING

Visby Lasarett

Visby, Sweden

RECRUITING

Ystad Lasarett

Ystad, Sweden

RECRUITING

Vrinnevisjukhuset

Norrköping, Östergötland County, Sweden

RECRUITING

Related Publications (3)

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

    PMID: 30070803BACKGROUND

  • 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.

    PMID: 33225484BACKGROUND

  • 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.

    PMID: 40036215DERIVED

Study Officials

  • Marie Blomberg, Professor

    Department of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Marie Blomberg, Professor

CONTACT

+4613288956marie.blomberg@liu.se

Anna Ramö Isgren, pHD

CONTACT

anna.ramo.isgren@regionostergotland.se

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: multicenter, stepped-wedge cluster randomized trial
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 17, 2022

First Posted

September 29, 2022

Study Start

November 15, 2023

Primary Completion

September 1, 2025

Study Completion (Estimated)

September 1, 2027

Last Updated

October 22, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

At present we are not allowed to share anonymized data extracted from Swedish medical health registers

Locations

SE(24)