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The Labour Progression Study, a Cluster Randomised Trial on Labour Progression for First Time Mothers (LAPS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02221427
Recruitment Status : Active, not recruiting
First Posted : August 20, 2014
Last Update Posted : July 19, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Condition or disease Intervention/treatment
Caesarean Sections Augmentation With Oxytocin Labour Dystocia Other: Dynamic progression curve Other: Static labour progression curve (F)

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Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6582 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: The Labour Progression Study, a Cluster Randomised Trial on Labour Progression for First Time Mothers
Study Start Date : December 2014
Primary Completion Date : March 2017
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: Static labour progression curve (F)
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)
Experimental: Dynamic progression curve (Z)
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
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.
Other Name: Zhang's progression curve


Outcome Measures

Primary Outcome Measures :
  1. Rate of emergency caesarean section [ Time Frame: 14 months ]

Secondary Outcome Measures :
  1. The use of oxytocin for augmenting uterus contractions [ Time Frame: 14 months ]
    The rate of women augmented with oxytocin including indication for initiating oxytocin infusion, cervical dilatation at onset of augmentation and length of augmentation


Other Outcome Measures:
  1. The rate of instrumental vaginal deliveries [ Time Frame: 14 months ]
    The rate of both vacuum extractions and forceps deliveries

  2. The rate of artificial rupture of membranes (amniotomy) [ Time Frame: 14 months ]
  3. The rate of electronic fetal monitoring [ Time Frame: 14 months ]
    Electronic fetal monitoring including cardio tocography (CTG) both with and without ST analysis (STAN) will be recorded

  4. The rate of epidural analgesia [ Time Frame: 14 months ]
  5. The rate of episiotomies [ Time Frame: 14 months ]
  6. The rate of anal sphincter injuries [ Time Frame: 14 months ]
  7. The rate of labour dystocia [ Time Frame: 14 months ]
    The rate of prolonged labour according to allocated guideline for labour progression

  8. Postpartum haemorrhage [ Time Frame: 14 months ]
    The rate of postpartum haemorrhage of more than 1000 ml and the rate of blood transfusions post partum

  9. Apgar scores [ Time Frame: 14 months ]
    The rate of apgar scores less or equal to 7 after 10 minutes post partum

  10. Ph in the umbilical artery [ Time Frame: 14 months ]
  11. The rate of transfers of neonates to the Neonatal Intensive Care Unit [ Time Frame: 14 months ]
    The rate of transfers of neonates within two hours post partum

  12. The mean duration of labour [ Time Frame: 14 months ]
    The duration of labour in all phases of labour and in total

  13. • Mean score of women's experience with child birth (measured by :"The Childbirth Experience Questionnaire, CEQ" [ Time Frame: 14 months ]
    Four weeks after birth all Robson group I women will receive a request to complete an online questionnaire regarding birth experience, the Childbirth Experience Questionnaire CEQ


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Robson groups 2-10
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02221427


Locations
Norway
Østfold Hospital Trust
Fredrikstad, Østfold, Norway, 1603
Sponsors and Collaborators
Ostfold Hospital Trust
Investigators
Principal Investigator: Stine Bernitz, PhD Østfold Hospital Trust
More Information

Responsible Party: Stine Bernitz, Midwife, PhD, Ostfold Hospital Trust
ClinicalTrials.gov Identifier: NCT02221427     History of Changes
Other Study ID Numbers: LAPS3293
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: July 19, 2017
Last Verified: July 2017

Keywords provided by Stine Bernitz, Ostfold Hospital Trust:
First time mothers
Labour progression
Prolonged labour
Oxytocin
Mode of delivery
Maternal birth outcome
Neonatal birth outcome

Additional relevant MeSH terms:
Disease Progression
Dystocia
Disease Attributes
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications