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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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23 February 2016 |
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Main ID: |
NCT02599610 |
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Date of registration:
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05/11/2015 |
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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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Effects of Digital Vaginal Examination During Labor on Pain and Anxiety Levels
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Scientific title:
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Effects of Digital Vaginal Examination During Labor on Pain and Anxiety : a Randomised Controlled Trial |
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Date of first enrolment:
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October 2015 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02599610 |
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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, Masking: Single Blind (Outcomes Assessor)
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Phase:
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N/A
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Countries of recruitment
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Turkey
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Contacts
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Name:
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Erkan Kalafat, MD |
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Address:
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Telephone:
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05334736998 |
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Email:
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ekalafat@ankara.edu.tr |
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Affiliation:
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Name:
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Erkan Kalafat |
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Address:
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Telephone:
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Email:
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ekalafat@ankara.edu.tr |
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Affiliation:
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Name:
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Erkan Kalafat, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Ankara University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Multiparous women
- Spontaneous active labor
- Cephalic presentation
Exclusion Criteria:
- Women with known psychiatric disorders
- Labor induction
- Advanced labor during admission (Dilatation greater than 7cm)
- Presence of a prenatally diagnosed anomaly in fetus
- Admission to neonatal intensive care unit after delivery
- Delayed hospital discharge due to excessive weight loss of neonate
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Pregnancy
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Obstetric Labor
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Intervention(s)
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Other: Digital vaginal examination
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Device: Transperineal ultrasound examination
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Primary Outcome(s)
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Anxiety levels
[Time Frame: Between 12 to 48 hours]
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Labor pain
[Time Frame: Between 12 to 48 hours]
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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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