FearNCT01424059
Induction of Women With Fear of Labor
An observational study of Fear, run by Uppsala University Hospital at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Fear
- What is being tested?
- WEDQ-B (questionnaire)
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- Jan 2011to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Parous women with cercvical status allowing amniotomy as method for induction. Parous women planned for cesarean section.
Who may be able to join
- parous
- induction or cesarean section
- amniotomy
Who cannot join
- non proficiency in the Swedish language
Trial locations and contacts
1 site in 1 country.
Sweden1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Akademiska hospital
Uppsala, 751 85
Maria Jonsson, M.D., Ph.D, +466110000
About this study
Official title: 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).
Read more
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
- Conditions
- Fear
- Being tested
- WEDQ-B (questionnaire)
- Keywords
- fear, labor, induction, amniotomy, WEDQ-B, parous, cesarean section
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WEDQ-B (questionnaire)Other
Questionnaires are answered after delivery; within 48 hours and after five weeks
| Study group | Role | What they receive |
|---|---|---|
| fear of labor | Parous women with fear of labor Receives: Other: WEDQ-B (questionnaire) |
What is being measured
The primary outcome is the main question the study is designed to answer.
experience of delivery
Experience of labor is evaluated with a questionnaire (WEDQ-B) within 48 hours
Measured: Within 48 hours after delivery
Secondary outcomes (1)
Operative delivery
within 48 hours from inclusion in the study
Measured: within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startJan 2011
- Primary completionDec 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Jonsson, Uppsala University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01424059
- Sponsor's protocol ID
- UAS-11
- Status last verified
- Aug 2011
- First submitted
- 5 Aug 2011
- Last updated
- 26 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Planned Induction of Women With Fear of Labor and Evaluation of the Experience of Delivery
- ClinicalTrials.gov ID
- NCT01424059
- Acronym / sponsor ID
- UAS-11
- Conditions
- Fear
- Keywords
- fear, labor, induction, amniotomy, WEDQ-B, parous, cesarean section
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Uppsala University HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 26 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fear of labor | – | Other: WEDQ-B (questionnaire)Parous women with fear of labor |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Parous women with cercvical status allowing amniotomy as method for induction. Parous women planned for cesarean section.
Key inclusion criteria (3 listed)
- parous
- induction or cesarean section
- amniotomy
Key exclusion criteria (1 listed)
- non proficiency in the Swedish language
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| WEDQ-B (questionnaire)Questionnaires are answered after delivery; within 48 hours and after five weeks | Other | fear of labor |
Primary outcome
experience of delivery
Time frame: Within 48 hours after delivery
Experience of labor is evaluated with a questionnaire (WEDQ-B) within 48 hours
1 secondary outcome
Operative delivery
Time frame: within 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fear, run by Uppsala University Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
experience of delivery (time frame: Within 48 hours after delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2011.