- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07272785
Maternal Informing on Labor Induction: Impact on Childbirth Experience
Study Overview
Status
Detailed Description
Subject undergoing planned induction of labor will be recruited. At recruitment the participants will be asked to answer a questionnaire. Follow-up questionnaires will be sent to the participants one week and three months after the induction.
The first questionnaire assesses how well the participants were informed about the induction. The following questionnaires will assess the childbirth experience and induction experience.
The main aim of the study is to investigate whether being being well informed about the induction of labor is related to better experience of childbirth. Moreover, the correlation between reported social media use and childbirth experience will be evaluated.
After obtaining full data from the first 50 subjects an interim analysis will be performed, to decide the final target sample size.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Mikael Huhtala, M.D., Ph.D.
- Phone Number: +35823130000
- Email: misahu@utu.fi
Study Locations
-
-
-
Turku, Finland
- Recruiting
- Turku University Hospital
-
Contact:
- Mikael Huhtala
- Phone Number: +35823130000
- Email: misahu@utu.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Planned induction of labor at the antenatal ward or at the outpatient clinic
- Adequate language skills (Finnish, Swedish, English)
Exclusion Criteria:
- Induction at the delivery ward or at the obstetric emergency care clinic
- Spontaneous onset of labor or a planned cesarean delivery
- Age below 18 years at the time of recruitment
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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Subject undergoing planned induction of labor
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childbirth experience
Time Frame: Three months after induction of labor
|
Childbirth experience assessed using visual analog scale (VAS) where 0 is the worst possible and 10 the best possible childbirth experience.
|
Three months after induction of labor
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Childbirth experience
Time Frame: One week after induction of labor
|
Childbirth experience assessed using visual analog scale (VAS) where 0 is the worst possible and 10 the best possible childbirth experience.
|
One week after induction of labor
|
|
Experience of labor induction
Time Frame: One week after induction of labor
|
Assessed using visual analog scale (VAS) where 0 is the worst possible and 10 the best possible labor induction experience.
|
One week after induction of labor
|
|
Experience of labor induction
Time Frame: Three months after induction of labor
|
Assessed using visual analog scale (VAS) where 0 is the worst possible and 10 the best possible labor induction experience.
|
Three months after induction of labor
|
|
Did childbirth experience meet participant's expectations
Time Frame: One week after induction of labor
|
Four points Likert scale with the following possible answers: 1) very poorly, 2) quite poorly, 3) quite well, 4) very well.
|
One week after induction of labor
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mikael Huhtala, M.D., Ph.D., Turku University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- OP2025/8882
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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