NCT06357468

Brief 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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 30, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 10, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 14, 2025

Status Verified

March 1, 2025

Enrollment Period

1.5 years

First QC Date

March 30, 2024

Last Update Submit

March 11, 2025

Conditions

Pain, Labor

Outcome Measures

Primary Outcomes (1)

  • Pain perception

    Measured by visual pain scale (1-10)

    intrapartum (start of labour until end of labour) and postpartum first 3 days after birth

Secondary Outcomes (2)

  • Satisfaction with pain therapy

    intrapartum (start of labour until end of labour) and postpartum first 3 days after birth

  • Pain perception in women with perineal tear grade III

    postpartum first 3 days after birth

Study Arms (2)

physician-led births

Other: midwife-led births in low risk women in pregnancy

midwife-led births

Interventions

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

physician-led births

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

pregnant women under birth

You may qualify if:

  • Understanding written and spoken German
  • Declaration of consent

You may not qualify if:

  • under 18 years
  • incomplete answered questionaire

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Halle

Halle, Saxony-Anhalt, 06120, Germany

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Pregnancy

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ReproductionReproductive Physiological PhenomenaReproductive and Urinary Physiological Phenomena

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 30, 2024

First Posted

April 10, 2024

Study Start

January 1, 2023

Primary Completion

June 30, 2024

Study Completion

December 31, 2024

Last Updated

March 14, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)