Induction of Women With Fear of Labor

Fear Clinical Trial

Official title:

Planned Induction of Women With Fear of Labor and Evaluation of the Experience of Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01424059
• Other study ID #: UAS-11
• Status: Recruiting
• Phase: N/A
• First received: August 5, 2011
• Last updated: August 24, 2011
• Start date: January 2011
• Est. completion date: December 2013

Study information

• Verified date: August 2011
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 250
• Est. completion date: December 2013
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• parous

• induction or cesarean section

• amniotomy

Exclusion Criteria:

• non proficiency in the Swedish language

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Fear

Intervention

Other:
• WEDQ-B (questionnaire)
Questionnaires are answered after delivery; within 48 hours and after five weeks

Locations

Country	Name	City	State
Sweden	Department of Obstetrics and Gynecology, Akademiska hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	experience of delivery	Experience of labor is evaluated with a questionnaire (WEDQ-B) within 48 hours	Within 48 hours after delivery	No
Secondary	Operative delivery	within 48 hours from inclusion in the study	within 48 hours	No