- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04391075
Analgesia in the Second Stage of Labour (ASL)
Analgesia in the Second Stage of Labour - With Special Focus on Pudendal Block
Study Overview
Status
Intervention / Treatment
Detailed Description
Pudendal block is used when there is a need to alleviate pain in the final stage of labour:
- From fully dilated cervix to delivery of the child.
- Associated with pain as the foetus rotates and descends through the pelvis.
- End of second stage: the perineum dilates as the child is being born.
Pudendal block is provided by inserting a needle close to the pudendal nerve that runs through the pelvis and innervates the perineal area.Pudendal block is an old and relatively simple method, but not well studied. The main aim is to study pudendal nerve block as pain relief in final stage of labour for primiparous women delivering vaginally.
The investigators aim to investigate whether possible adverse effects may outweigh the positive analgesic effect in the final stage of labour, or the opposite. The ASL (Analgesia in the Second stage of Labour) study may fill knowledge gaps and add important knowledge regarding pain relief during the final stage of childbirth.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Norwegian-speaking/reading
- Primiparity
- Single pregnancy
- Vaginal birth
- Cephalic presentation
- ≥37+0
- Age ≥18 years
Exclusion Criteria:
- Transferre from midwifery-led birth unit
- Allergy to local anaesthesia
- Not valid data on pudendal block
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Exposed
Pudendal nerve block provided
|
Pudendal nerve block provided during last fase of delivery
|
Not exposed
Pudendal nerve block is NOT provided
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Childbirth experience
Time Frame: Responds to questionnaire 4-12 weeks after delivery.
|
Childbirth experience questionnaire (CEQ), total score on a scale from 1.0 to 4.0.
Higher score means better experience.
|
Responds to questionnaire 4-12 weeks after delivery.
|
Urinary retention
Time Frame: 3 hours
|
Urinary retention after delivery defined as inability to void and need for catheterization within 3 hours.
|
3 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain, obstetric
Time Frame: Responds to questionnaire 4-12 weeks after delivery.
|
Measured by Visual Analog Scale (VAS).
Scale from 0 to 100, higher scpre means more pain.
|
Responds to questionnaire 4-12 weeks after delivery.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Anne Flem Jacobsen, PhD, Univeristy of Oslo
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2016/18884
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- Study Protocol
- Informed Consent Form (ICF)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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