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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT02306434 |
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Date of registration:
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01/12/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Fear of Childbirth - Comparison of Two Treatments
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Scientific title:
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Fear of Childbirth - Comparison of Two Treatment Options: Internet Given Behavioral Therapy and Counseling by Midwife- a Clinical Randomized Controlled Trial |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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258 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02306434 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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N/A
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Christine Rubertsson, Ass Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Uppsala University Hospital |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Mastery of the Swedish language,
- FOBS above 60,
- internet access
Exclusion Criteria:
Age minimum:
N/A
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Fear of Childbirth
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Pregnancy
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Intervention(s)
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Other: Standard care-counselling
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Behavioral: Therapy by iCBT
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Primary Outcome(s)
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Level of childbirth related fear (FOBS)
[Time Frame: 36 weeks of gestation]
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Secondary Outcome(s)
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Level of childbirth related fear (FOBS)
[Time Frame: 1 year post-partum]
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Preferred mode of birth (vaginal or cesarean section)
[Time Frame: 36 weeks of gestation]
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Level of childbirth related fear (FOBS)
[Time Frame: 2 months post-partum]
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Request for cesarean section (yes or no)
[Time Frame: 1 year postpartum]
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Secondary ID(s)
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U-CARE: Pregnancy
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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