NCT02221427

Brief Summary

The purpose of this study is to evaluate if the rate of emergency caesarean section can be reduced if adhering to a dynamic labour progression curve compared to a static progression curve for first time mothers without jeopardising maternal and neonatal outcomes

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6,582

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

August 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 20, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

December 1, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
8.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

November 14, 2023

Status Verified

November 1, 2023

Enrollment Period

2.2 years

First QC Date

August 18, 2014

Last Update Submit

November 13, 2023

Conditions

Caesarean SectionsAugmentation With OxytocinLabour Dystocia

Keywords

First time mothersLabour progressionProlonged labourOxytocinMode of deliveryMaternal birth outcomeNeonatal birth outcome

Outcome Measures

Primary Outcomes (1)

  • Rate of emergency caesarean section

    14 months

Secondary Outcomes (1)

  • The use of oxytocin for augmenting uterus contractions

    14 months

Other Outcomes (13)

  • The rate of instrumental vaginal deliveries

    14 months

  • The rate of artificial rupture of membranes (amniotomy)

    14 months

  • The rate of electronic fetal monitoring

    14 months

  • +10 more other outcomes

Study Arms (2)

Static labour progression curve (F)

ACTIVE COMPARATOR

Guideline with the following expected labour progression: if the cervix dilates at least 1 centimetre per hour assessed after 4 hours. Labour dystocia is diagnosed if progression proceeds slower than this definition throughout the active phase of the first stage of labour. Labour dystocia in the second stage of labour is diagnosed if lasting longer than two hours, three hours for women with epidurals or if the expulsion phase lasts longer than 60 minutes.

Other: Static labour progression curve (F)

Dynamic progression curve (Z)

EXPERIMENTAL

Guideline which takes into account the dilatation of the cervix on admission and calculates the expected progression during the active phase of the first stage of labour based on this finding. Labour dystocia in the second stage of labour is diagnosed if lasting longer than two hours and 45 minutes, three hours and 30 minutes for women with epidurals or if the expulsion phase lasts longer than 60 minutes.

Other: Dynamic progression curve

Interventions

Dynamic progression curveOTHER

Guideline which takes into account the dilatation of the cervix on admission and calculates the expected progression during the active phase of the first stage of labour based on this finding. Labour dystocia in the second stage of labour is diagnosed if lasting longer than two hours and 45 minutes, three hours and 30 minutes for women with epidurals or if the expulsion phase lasts longer than 60 minutes. This guideline is based on the labour progression curve by Zhang.

Also known as: Zhang's progression curve
Dynamic progression curve (Z)
Static labour progression curve (F)OTHER
Static labour progression curve (F)

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Robson group I:First time mothers with a singleton foetus in a vertex position, in spontaneous onset of labour between gestational week 37-42

You may not qualify if:

  • Robson groups 2-10

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Østfold Hospital Trust

Fredrikstad, Østfold fylke, 1603, Norway

Location

Related Publications (3)

  • Husby AE, Simpson MR, Dalbye R, Larsen M, Vanky E, Lovvik TS. Childbirth experiences in women with polycystic ovary syndrome: A cohort study. Acta Obstet Gynecol Scand. 2024 Jun;103(6):1092-1100. doi: 10.1111/aogs.14800. Epub 2024 Feb 17.

    PMID: 38366810DERIVED

  • Bernitz S, Dalbye R, Zhang J, Eggebo TM, Froslie KF, Olsen IC, Blix E, Oian P. The frequency of intrapartum caesarean section use with the WHO partograph versus Zhang's guideline in the Labour Progression Study (LaPS): a multicentre, cluster-randomised controlled trial. Lancet. 2019 Jan 26;393(10169):340-348. doi: 10.1016/S0140-6736(18)31991-3. Epub 2018 Dec 20.

    PMID: 30581039DERIVED

  • Bernitz S, Dalbye R, Oian P, Zhang J, Eggebo TM, Blix E. Study protocol: the Labor Progression Study, LAPS - does the use of a dynamic progression guideline in labor reduce the rate of intrapartum cesarean sections in nulliparous women? A multicenter, cluster randomized trial in Norway. BMC Pregnancy Childbirth. 2017 Nov 13;17(1):370. doi: 10.1186/s12884-017-1553-8.

    PMID: 29132336DERIVED

Study Officials

  • Stine Bernitz, PhD

    Ostfold Hospital Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Midwife, PhD

Study Record Dates

First Submitted

August 18, 2014

First Posted

August 20, 2014

Study Start

December 1, 2014

Primary Completion

March 1, 2017

Study Completion

December 1, 2025

Last Updated

November 14, 2023

Record last verified: 2023-11

Locations

NO(1)