Analgesia in the Second Stage of Labour

NCT ID: NCT04391075

Last Updated: 2020-05-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1007 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2019-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Childbirth Experience Urinary Retention Satisfaction, Personal Pain, Obstetric

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Exposed

Pudendal nerve block provided

Pudendal nerve block

Intervention Type PROCEDURE

Pudendal nerve block provided during last fase of delivery

Not exposed

Pudendal nerve block is NOT provided

No interventions assigned to this group

Interventions

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Pudendal nerve block

Pudendal nerve block provided during last fase of delivery

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Oslo University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Åsa Waldum

Midwife/PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anne Flem Jacobsen, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of Oslo

Other Identifiers

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2016/18884

Identifier Type: -

Identifier Source: org_study_id

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