Analgesia in the Second Stage of Labour (ASL)

Analgesia in the Second Stage of Labour - With Special Focus on Pudendal Block

This study investigates efficacy, safety and childbirth experience in women receiving pudendal block during the final stage of delivery. It is an observational study and half of included primarous women recieve a pudendal block.

Study Overview

• Status: Completed
• Conditions: Urinary Retention; Satisfaction, Personal; Childbirth Experience; Pain, Obstetric
• Intervention / Treatment: Procedure: Pudendal nerve block

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: Observational
• Enrollment (Actual): 1007

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

Study Population

The participants is selected from 2 delivery units at Oslo Univeristy Hospital (OUH) in Oslo, Norway. OUH is a third referral hospital, the largest Obstetrics Dept. in Norway, and accounting for 1/6 of all deliveries in Norway (9600 deliveries/year).

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

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Exposed; Pudendal nerve block provided	Procedure: Pudendal nerve block; 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	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	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	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: Oslo University Hospital
• Investigators: Principal Investigator: Anne Flem Jacobsen, PhD, Univeristy of Oslo

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Actual): May 1, 2019
• Study Completion (Actual): May 31, 2019

Study Registration Dates

• First Submitted: May 12, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 18, 2020

Study Record Updates

• Last Update Posted (Actual): May 19, 2020
• Last Update Submitted That Met QC Criteria: May 15, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Anesthetics; Pudendal nerve block; Urine and urination; Peripheral nervous system agents
• Additional Relevant MeSH Terms: Urologic Diseases; Pain; Neurologic Manifestations; Urination Disorders; Labor Pain; Urinary Retention
• Other Study ID Numbers: 2016/18884

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Anonymous individual participant data for the primary outcome measures will be made available on request, when the study is finished. Access to data will be restricted due to sensitive nature of the data, but will be shared if asked for within the anonymous data restriction imposed by the patient consent and ethical body approval.
• IPD Sharing Time Frame: Data will be available on request within 1 year after study completion.
• IPD Sharing Access Criteria: Data access will be considered on specific request. Requestors wil be required to sign a Data Access Agreement.
• 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: No
• Studies a U.S. FDA-regulated device product: No