Induction of Women With Fear of Labor | NCT01424059

Studies
Induction of Women With Fear of Labor

NCT01424059

Sponsor

Uppsala University Hospital

Status

Unknown status

Last Update Posted

Aug 26, 2011Estimated

Enrollment

250Estimated

Phase

Not provided

Conditions

Fear

Interventions

WEDQ-B (questionnaire)

Countries

Sweden

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2011

Primary Completion Date

Dec 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Aug 5, 2011

First Submission Date that Met QC Criteria

Aug 24, 2011

First Posted Date

Aug 26, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 24, 2011

Last Update Posted Date

Aug 26, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Maria Jonsson, M.D., Ph.D. Consultant, Uppsala University HospitalPrincipal Investigator

Lead Sponsor

Uppsala University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

250Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
fear of labor		Parous women with fear of labor	Other: WEDQ-B (questionnaire)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
WEDQ-B (questionnaire)	Other	Questionnaires are answered after delivery; within 48 hours and after five weeks	fear of labor

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
experience of delivery	Experience of labor is evaluated with a questionnaire (WEDQ-B) within 48 hours	Within 48 hours after delivery

Secondary Outcomes

Measure	Description	Time Frame
Operative delivery	within 48 hours from inclusion in the study	within 48 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

parous
induction or cesarean section
amniotomy

Exclusion Criteria:

non proficiency in the Swedish language

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department of Obstetrics and Gynecology, Akademiska hospital	Recruiting	Uppsala		751 85	Sweden

Intervention Browse Module

MeSH Terms

ID	Term
D011795	Surveys and Questionnaires

Ancestor Terms

ID	Term
D003625	Data Collection
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms

Browse Leaves

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Browse Branches

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