Pain, LaborNCT06357468
Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women with Vaginal Births in Difference Between Physician-led and Midwife-led Birth
An observational study of Pain, Labor, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
The aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pain, Labor
- What is being tested?
- midwife-led births in low risk women in pregnancy
- How many people
- 237 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2023to 31 Dec 2024
- 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
- No healthy volunteers
- Adult, Older adult
Study population: pregnant women under birth
Who may be able to join
- Understanding written and spoken German
- Declaration of consent
Who cannot join
- under 18 years
- incomplete answered questionaire
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births
- Conditions
- Pain, Labor
- Being tested
- midwife-led births in low risk women in pregnancy
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
midwife-led births in low risk women in pregnancyOther
Pregnant women in the low-risk collective are cared for in a midwife-led delivery room if they wish to have a natural birth
| Study group | Role | What they receive |
|---|---|---|
| physician-led births | Not described Receives: Other: midwife-led births in low risk women in pregnancy | |
| midwife-led births | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain perception
Measured by visual pain scale (1-10)
Measured: intrapartum (start of labour until end of labour) and postpartum first 3 days after birth
Secondary outcomes (2)
Satisfaction with pain therapy
Measured by visual analog scale (1-10)
Measured: intrapartum (start of labour until end of labour) and postpartum first 3 days after birth
Pain perception in women with perineal tear grade III
Measured by visual pain scale (1-10)
Measured: postpartum first 3 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2024
- Study start1 Jan 2023
- Primary completion30 Jun 2024
- Study completion31 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, LaborStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 237 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Riemer, MD, Martin-Luther-Universität Halle-Wittenberg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06357468
- Sponsor's protocol ID
- UKGEB003
- Status last verified
- Mar 2025
- First submitted
- 30 Mar 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women with Vaginal Births in Difference Between Physician-led and Midwife-led Birth
- ClinicalTrials.gov ID
- NCT06357468
- Acronym / sponsor ID
- UKGEB003
- Conditions
- Pain, Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 237 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 31 Dec 2024 (actual)
- First posted
- 10 Apr 2024 (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.
The aim of the analysis is to describe the differences and similarities in obstetric pain management and pain perception intrapartum and postpartum in women with vaginal births in contrast to physician-led births and midwife-led births
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physician-led births | – | Other: midwife-led births in low risk women in pregnancy |
| midwife-led births | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- pregnant women under birth
Key inclusion criteria (2 listed)
- Understanding written and spoken German
- Declaration of consent
Key exclusion criteria (2 listed)
- under 18 years
- incomplete answered questionaire
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 |
|---|---|---|
| midwife-led births in low risk women in pregnancyPregnant women in the low-risk collective are cared for in a midwife-led delivery room if they wish to have a natural birth | Other | physician-led births |
Primary outcome
Pain perception
Time frame: intrapartum (start of labour until end of labour) and postpartum first 3 days after birth
Measured by visual pain scale (1-10)
2 secondary outcomes
Satisfaction with pain therapy
Time frame: intrapartum (start of labour until end of labour) and postpartum first 3 days after birth
Pain perception in women with perineal tear grade III
Time frame: postpartum first 3 days after birth
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 14 Mar 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Labor, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 2 inclusion and 2 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 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Pain perception (time frame: intrapartum (start of labour until end of labour) and postpartum first 3 days after birth). 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 14 Mar 2025.