Childbirth ExperienceASLNCT04391075
Analgesia in the Second Stage of Labour
An observational study of Childbirth Experience and Urinary Retention, run by Oslo University Hospital.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Childbirth Experience, Urinary Retention, Satisfaction, Personal
- What is being tested?
- Pudendal nerve block
- Type of treatment
- Surgery or procedure
- How many people
- 1,007 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2017to 31 May 2019
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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).
Who may be able to join
- Norwegian-speaking/reading
- Primiparity
- Single pregnancy
- Vaginal birth
- Cephalic presentation
- ≥37+0
- Age ≥18 years
Who cannot join
- Transferre from midwifery-led birth unit
- Allergy to local anaesthesia
- Not valid data on pudendal block
About this study
Official title: 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.
Read the 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.
- Being tested
- Pudendal nerve block
- Keywords
- Pudendal nerve block, Urine and urination, Anesthetics, Peripheral nervous system agents
- Medical subject headings
- Urinary Retention, Personal Satisfaction, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal nerve blockProcedure or surgery
Pudendal nerve block provided during last fase of delivery
| Study group | Role | What they receive |
|---|---|---|
| Exposed | Pudendal nerve block provided Receives: Procedure: Pudendal nerve block | |
| Not exposed | Pudendal nerve block is NOT provided |
What is being measured
The primary outcome is the main question the study is designed to answer.
Childbirth experience
Childbirth experience questionnaire (CEQ), total score on a scale from 1.0 to 4.0. Higher score means better experience.
Measured: 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.
Measured: 3 hours
Secondary outcomes (1)
Pain, obstetric
Measured by Visual Analog Scale (VAS). Scale from 0 to 100, higher scpre means more pain.
Measured: Responds to questionnaire 4-12 weeks after delivery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start1 Jan 2017
- Primary completion1 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childbirth ExperienceStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,007 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Åsa Waldum, Oslo University Hospital
- Investigators
- Anne Flem Jacobsen, PhD, Principal investigator, Univeristy of Oslo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391075
- Sponsor's protocol ID
- 2016/18884
- Other IDs
- 2016
- Acronym
- ASL
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesia in the Second Stage of Labour - With Special Focus on Pudendal Block
- ClinicalTrials.gov ID
- NCT04391075
- Acronym / sponsor ID
- ASL / 2016/18884
- Keywords
- Pudendal nerve block, Urine and urination, Anesthetics, Peripheral nervous system agents
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,007 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed | – | Procedure: Pudendal nerve blockPudendal nerve block provided |
| Not exposed | – | –Pudendal nerve block is NOT provided |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (7 listed)
- Norwegian-speaking/reading
- Primiparity
- Single pregnancy
- Vaginal birth
- Cephalic presentation
Key exclusion criteria (3 listed)
- Transferre from midwifery-led birth unit
- Allergy to local anaesthesia
- Not valid data on pudendal block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal nerve blockPudendal nerve block provided during last fase of delivery | Procedure or surgery | Exposed |
Primary outcome
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.
Urinary retention
Time frame: 3 hours
Urinary retention after delivery defined as inability to void and need for catheterization within 3 hours.
1 secondary outcome
Pain, obstetric
Time frame: Responds to questionnaire 4-12 weeks after delivery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Flem Jacobsen, PhD principal investigator
Univeristy of Oslo
Questions about this trial
What is this clinical trial studying?
An observational study of Childbirth Experience and Urinary Retention, run by Oslo University Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Childbirth experience (time frame: Responds to questionnaire 4-12 weeks after delivery.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2020.