NCT01424059

Brief 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

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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, 2011

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 5, 2011

Completed
21 days until next milestone

First Posted

Study publicly available on registry

August 26, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

August 26, 2011

Status Verified

August 1, 2011

Enrollment Period

2.9 years

First QC Date

August 5, 2011

Last Update Submit

August 24, 2011

Conditions

Fear

Keywords

fearlaborinductionamniotomyWEDQ-Bparouscesarean section

Outcome Measures

Primary Outcomes (1)

  • experience of delivery

    Experience of labor is evaluated with a questionnaire (WEDQ-B) within 48 hours

    Within 48 hours after delivery

Secondary Outcomes (1)

  • Operative delivery

    within 48 hours

Study Arms (1)

fear of labor

Parous women with fear of labor

Other: WEDQ-B (questionnaire)

Interventions

WEDQ-B (questionnaire)OTHER

Questionnaires are answered after delivery; within 48 hours and after five weeks

fear of labor

Eligibility Criteria

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

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

You may qualify if:

  • parous
  • induction or cesarean section
  • amniotomy

You may not qualify if:

  • non proficiency in the Swedish language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Akademiska hospital

Uppsala, 751 85, Sweden

RECRUITING

MeSH Terms

Interventions

Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Data CollectionEpidemiologic MethodsInvestigative TechniquesHealth Care Evaluation MechanismsQuality of Health CareHealth Care Quality, Access, and EvaluationPublic HealthEnvironment and Public Health

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.D., Ph.D. Consultant

Study Record Dates

First Submitted

August 5, 2011

First Posted

August 26, 2011

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

August 26, 2011

Record last verified: 2011-08

Locations

SE(1)