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Completed

NCT Number: NCT04391075

Analgesia in the Second Stage of Labour

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.

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Key information

Conditions

Childbirth Experience Behavior Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Labor Pain Male Urogenital Diseases Neurologic Manifestations Pain Pain, Obstetric Pathological Conditions, Signs and Symptoms Personal Satisfaction Satisfaction, Personal Signs and Symptoms Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pudendal nerve block

Procedure

Pudendal nerve block provided during last fase of delivery

Primary outcomes

  1. 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.

  2. Urinary retention

    Time frame: 3 hours

    Urinary retention after delivery defined as inability to void and need for catheterization within 3 hours.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Registry information

Official study title

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

Acronym: ASL

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 18, 2020
Registry last updated
May 19, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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