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Induction of Women With Fear of Labor

This study is currently recruiting participants.
Verified August 2011 by Uppsala University Hospital
Sponsor:
Information provided by (Responsible Party):
Maria Jonsson, Uppsala University Hospital
ClinicalTrials.gov Identifier:
NCT01424059
First received: August 5, 2011
Last updated: August 24, 2011
Last verified: August 2011
History of Changes
  Purpose

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

Condition Intervention
Fear
 Other: WEDQ-B (questionnaire)

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Planned Induction of Women With Fear of Labor and Evaluation of the Experience of Delivery

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
U.S. FDA Resources

Further study details as provided by Uppsala University Hospital:

Primary Outcome Measures:
  • experience of delivery [ Time Frame: Within 48 hours after delivery ] [ Designated as safety issue: No ]
    Experience of labor is evaluated with a questionnaire (WEDQ-B) within 48 hours


Secondary Outcome Measures:
  • Operative delivery [ Time Frame: within 48 hours ] [ Designated as safety issue: No ]
    within 48 hours from inclusion in the study


Estimated Enrollment: 250
Study Start Date: January 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
fear of labor
Parous women with fear of labor
 Other: WEDQ-B (questionnaire)
Questionnaires are answered after delivery; within 48 hours and after five weeks

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Parous women with cercvical status allowing amniotomy as method for induction. Parous women planned for cesarean section.

Criteria

Inclusion Criteria:

  • parous
  • induction or cesarean section
  • amniotomy

Exclusion Criteria:

  • non proficiency in the Swedish language
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01424059

Locations
Sweden
Department of Obstetrics and Gynecology, Akademiska hospital Recruiting
Uppsala, Sweden, 751 85
Contact: Maria Jonsson, M.D., Ph.D     +466110000        
Sponsors and Collaborators
Uppsala University Hospital
  More Information

No publications provided

Responsible Party: Maria Jonsson, M.D., Ph.D. Consultant, Uppsala University Hospital
ClinicalTrials.gov Identifier: NCT01424059     History of Changes
Other Study ID Numbers: UAS-11
Study First Received: August 5, 2011
Last Updated: August 24, 2011
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Uppsala University Hospital:
fear
labor
induction
amniotomy
 WEDQ-B
parous
cesarean section

ClinicalTrials.gov processed this record on May 23, 2013