- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01424059
Induction of Women With Fear of Labor
Planned Induction of Women With Fear of Labor and Evaluation of the Experience of Delivery
The purpose of this study is to evaluate the experience of labor in parous women induced because of fear of labor and, to compare the experience of parous women induced without fear of labor. A comparison with the experience of women delivered with elective cesarean section because of fear of labor is done.
In the induced labors, the induction method is amniotomy. Between groups the experience of delivery is evaluated with a questionnaire: Wijma Delivery Expectancy Questionnaire(WEDQ-B).
Groups are also compared with regard to time from induction to delivery and rate of operative delivery.
Hypotheses:
- there is no difference in experience of delivery
- there is no difference in time to delivery or rate of operative deliveries
Study Overview
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
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Uppsala, Sweden, 751 85
- Recruiting
- Department of Obstetrics and Gynecology, Akademiska hospital
-
Contact:
- Maria Jonsson, M.D., Ph.D
- Phone Number: +466110000
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- parous
- induction or cesarean section
- amniotomy
Exclusion Criteria:
- non proficiency in the Swedish language
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
fear of labor
Parous women with fear of labor
|
Questionnaires are answered after delivery; within 48 hours and after five weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
experience of delivery
Time Frame: Within 48 hours after delivery
|
Experience of labor is evaluated with a questionnaire (WEDQ-B) within 48 hours
|
Within 48 hours after delivery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Operative delivery
Time Frame: within 48 hours
|
within 48 hours from inclusion in the study
|
within 48 hours
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
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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