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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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ISRCTN |
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Last refreshed on:
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17 October 2016 |
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Main ID: |
ISRCTN30949871 |
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Date of registration:
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13/05/2015 |
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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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Cervical resistance during balloon dilatation
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Scientific title:
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Analysis of cervical resistance during continuous controllable balloon dilatation |
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Date of first enrolment:
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01/05/2013 |
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Target sample size:
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42 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN30949871 |
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Study type:
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Interventional |
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Study design:
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Prospective experimental randomised study (Other)
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Phase:
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Countries of recruitment
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Serbia
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Contacts
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Name:
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Petar
Arsenijevic |
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Address:
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Mite Cenica 22
34000
Kragujevac
Serbia |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age 18-40
2. Pregnancy verified by an ultrasound
3. Singleton pregnancy
4. Gestational age of 10 weeks or less
5. Absence of uterine bleeding or cramping
6. Cervix and uterus without pathological changes
7. Closed external cervical os
Exclusion criteria: 1. Any previous attempt at an abortion or use of substances for cervical maturation
2. Multiple pregnancy
3. Presence or, at minimum, the suspicion of a septic abortion, followed by an elevated body temperature of 38°C or higher, uterine pain and odorous vaginal secretions.
4. Presence of any previous intervention performed on the uterine cervix
5. Uterine or cervical anomalies
6. Intrauterine device in situ
7. Hemorrhagic and/or chronic diseases
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical resistance during continuous controllable balloon dilatation prior to termination of unwanted pregnancy.
Not Applicable
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Intervention(s)
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To measure and determine the location of cervical resistance: an improved system for continuous and controllable balloon dilatation (CCBD) (a programmed hydrostatic pump connected to a balloon extension) will be used. CCBD uses two pressure-measuring films on the top and on the bottom of the balloon extension. The dilation process is analysed using Dilation Controller software. The software monitors the dilation process in real time and controls the given mode of dilation.
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Primary Outcome(s)
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To precisely measure, analyse and map the cervical canal during dilatation of the uterine cervix, and locate every point of resistance along the upper and lower sides of the cervical canal.
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Secondary Outcome(s)
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1. Association between values of cervical resistance and the number of previous miscarriages
2. Association between the values of cervical breaking point and number of previous miscarriages
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Secondary ID(s)
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III 41007
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Source(s) of Monetary Support
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Ministry of Education, Science and Technological Development (Serbia)
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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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