Analgesia in the Second Stage of Labour

NCT04391075 | Completed

• 1 other identifier: 2016/18884
• Study Type: observational
• Target: 1,007
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Childbirth Experience; Urinary Retention; Satisfaction, Personal; Pain, Obstetric

Keywords

Pudendal nerve block; Urine and urination; Anesthetics; Peripheral nervous system agents

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Pain, obstetric

  Responds to questionnaire 4-12 weeks after delivery.

Study Arms (2)

Exposed

Pudendal nerve block provided

Procedure: Pudendal nerve block

Not exposed

Pudendal nerve block is NOT provided

Interventions

Pudendal nerve block PROCEDURE

Pudendal nerve block provided during last fase of delivery

Exposed

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• Norwegian-speaking/reading
• Primiparity
• Single pregnancy
• Vaginal birth
• Cephalic presentation
• ≥37+0
• Age ≥18 years

You may not qualify if:

• Transferre from midwifery-led birth unit
• Allergy to local anaesthesia
• Not valid data on pudendal block

Sponsors & Collaborators

• Oslo University Hospital: lead

MeSH Terms

Conditions

Urinary Retention; Personal Satisfaction; Labor Pain

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anne Flem Jacobsen, PhD

  Univeristy of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Midwife/PhD student

Study Record Dates

• First Submitted: May 12, 2020
• First Posted: May 18, 2020
• Study Start: January 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: May 31, 2019
• Last Updated: May 19, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Data will be available on request within 1 year after study completion.
• Access Criteria: Data access will be considered on specific request. Requestors wil be required to sign a Data Access Agreement.