Analgesia in the Second Stage of Labour

Urinary Retention Clinical Trial

— ASL  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04391075
• Other study ID #: 2016/18884
• Status: Completed
• Start date: January 1, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: May 2020
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1007
• Est. completion date: May 31, 2019
• Est. primary completion date: May 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Childbirth Experience
• Labor Pain
• Pain, Obstetric
• Satisfaction, Personal
• Urinary Retention

Intervention

Procedure:
• Pudendal nerve block
Pudendal nerve block provided during last fase of delivery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	Urinary retention	Urinary retention after delivery defined as inability to void and need for catheterization within 3 hours.	3 hours
Secondary	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.