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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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20 November 2017 |
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Main ID: |
ISRCTN54007498 |
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Date of registration:
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21/06/2011 |
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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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Continuous Controllable Balloon Dilation (CCBD): a novel approach for cervix dilation
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Scientific title:
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Comparative analysis of the damage of the cervical canal during the dilation of the cervix by means of classical and hydraulic dilators |
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Date of first enrolment:
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01/09/2001 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN54007498 |
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Study type:
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Interventional |
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Study design:
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Interventional randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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Montenegro
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Contacts
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Name:
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Gordana
Vukcevic |
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Address:
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Clinical Center of Montenegro
81000
Podgorica
Montenegro |
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Telephone:
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- |
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Email:
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varkic@t-com.me |
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Affiliation:
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Name:
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Age from 19 to 40
2. Pregnancy verified by an ultrasound
3. Singleton pregnancy
4. Gestational age of 10 weeks or less (determined by the date of the last menstruation and verified by an ultrasound)
5. Uterus and cervix with normal findings
6. Absence of uterine contractions or bleeding
7. Cervix uteri maintained in full, external wall closed
Exclusion criteria: 1. Signs of spontaneous abortion (presence of the uterine bleeding, uterine contractions, with or without alteration of the cervix)
2. Former attempt of an abortion or usage of substances for cervical maturation
3. Multiple pregnancy
4. Presence or at least suspicion of a septic abortion, followed by increased body temperature of 38 degree celsius or higher, painful uterus and smelly vaginal secretion
5. Presence of any kind of former intervention on the uterine cervix
6. Uterine or cervical anomalies
7. Intra-uterine device in situ
8. Haemorrhagic diseases
9. Chronic diseases
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Cervical dilation
Pregnancy and Childbirth
Cervical dilation
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Intervention(s)
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This study was carried out in order to enable analysis of the results of CCBD application for cervix dilation in comparison with a representative of traditional mechanical dilation devices (HeD)
Group I (without dilations)
Group II (the dilations were performed by HeD)
Group III (the dilations were performed by CCBD)
CCBD is a fully controllable device for cervical dilation based on the use of a specially constructed balloon dilator (BD) which consists of three layers: inner silicone layer, central layer made from high strength fabric, and outer silicone layer. The maximum diameter of BD expansion is limited by the central layer. The outer silicone layer is in contact with the tissues of the cervix during the dilation process. This BD was tested on consistency and endurance at a pressure of 25 bars, without detected risk of breakage. The reliability of CCBD was confirmed in vitro and in vivo.
The whole dilation procedure using CCBD is performed continuously with just one dilator placement. For the purpose of this study CCBD was integrated in a system that enables real time data acquisition and monitoring of relevant parameters related to the biophysics of the dilation process. Dilation dynamics directly depend on the flow of an incompressible fluid to the BD which is an easily controllable parameter. As an incompressible working fluid, distilled water was used with the addition of non-ionic contrast medium (Ultravist-300, Schering AG). This enables the possibility for visual monitoring of the dilation process on Digital Subtraction Apparatus for angiography (DSA).
Tissue material for histology evaluation of cervical damage was obtained from endocervical mucosa by single curettage (Novac?s sonde was used) before and after dilation by HeD or CCBD. Samples were stained by haematoxylin-eosin (H&E) and analysed by the light microscope Olympus BX 51. Cervical tissue sections, stained with H&E, were examined under a low-power (100×) light microscope (Zeiss Axioskop 40
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Primary Outcome(s)
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Tissue material for histology evaluation of cervical damage:
1. Epithelium damage (grade 0, 1, 2)
2. Basal membrane damage (grade 0, 1)
3. Stromal damage (grade 0, 1)
4. Cervical haemorrhagia (grade 0, 1, 2, 3)
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Secondary Outcome(s)
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Semi-quantitative determination of tissue haemorrhagia
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Secondary ID(s)
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EP1299146
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Source(s) of Monetary Support
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AUDIOTEL d.o.o. Belgrade, 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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URL:
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