Analysis of Pain Management and Pain Perception Intrapartum and Postpartum in Women with Vaginal Births in Difference Between Physician-led and Midwife-led Birth

March 11, 2025 updated by: Marcus Riemer, MD, Martin-Luther-Universität Halle-Wittenberg
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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

237

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Saxony Anhalt
      • Halle, Saxony Anhalt, Germany, 06120
        • University Hospital of Halle

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

pregnant women under birth

Description

Inclusion Criteria:

  • Understanding written and spoken German
  • Declaration of consent

Exclusion Criteria:

  • under 18 years
  • incomplete answered questionaire

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
physician-led births
Other: midwife-led births in low risk women in pregnancy
Pregnant women in the low-risk collective are cared for in a midwife-led delivery room if they wish to have a natural birth
midwife-led births

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
intrapartum (start of labour until end of labour) and postpartum first 3 days after birth

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Satisfaction with pain therapy
Time Frame: intrapartum (start of labour until end of labour) and postpartum first 3 days after birth
Measured by visual analog scale (1-10)
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
Measured by visual pain scale (1-10)
postpartum first 3 days after birth

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Martin-Luther-Universität Halle-Wittenberg

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Actual)

June 30, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

March 30, 2024

First Submitted That Met QC Criteria

April 4, 2024

First Posted (Actual)

April 10, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UKGEB003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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