Cervical resistance during balloon dilatation

ISRCTN	ISRCTN30949871
DOI	https://doi.org/10.1186/ISRCTN30949871
Secondary identifying numbers	III 41007

Submission date: 30/04/2015
Registration date: 13/05/2015
Last edited: 30/10/2015

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Other

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Cervical dilatation is the term used to describe the opening of the cervix (entrance to the womb (uterus)). Cervical dilatation can occur naturally, such as during childbirth and miscarriage, or it can be caused by surgical or medical procedures, such as during a pregnancy termination (abortion). There are various mechanical devices available for surgeons or clinicians to use to open the cervix, however some of these devices carry a risk of causing complications, such as damage to the cervix or uterus. Hydraulic dilatation is an alternative method to open the cervix. This involves opening the cervix with a balloon placed within the cervix. Fluid is pumped into the balloon causing it to gently expand. The balloon’s expansion is controlled by a computer software system designed to provide continuous and controllable balloon dilatation (CCBD). The aim of this study is to test a new system for CCBD, which consists of a computer programmed hydrostatic pump connected to a balloon extension. This new CCBD method aims to measure and determine the strength of muscles within the cervix (cervical resistance), and also the location of cervical resistance, by placing two pressure-measuring films on the top and on the bottom of the balloon extension. This new system will be tested in women seeking a surgical abortion (vacuum aspiration).

Who can participate?
Pregnant women who have been pregnant for less than 10 weeks.

What does the study involve?
All participants have the new system for hydraulic dilatation during the abortion procedure.

What are the possible benefits and risks of participating?
The intervention is considered to be completely risk free and thus, beneficial for the patient.

Where is the study run from?
Clinical Center Kragujevac (Serbia)

When is the study starting and how long is it expected to run for?
May 2013 to September 2013

Who is funding the study?
Ministry of Education, Science and Technological Development (Serbia)

Who is the main contact?
Dr P Arsenijevic

Study website

Contact information

Dr Petar Arsenijevic
Scientific

Mite Cenica 22
Kragujevac
34000
Serbia

ORCID ID	0000-0001-8267-7717

Study information

Study design	Prospective experimental randomised study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Other
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	Analysis of cervical resistance during continuous controllable balloon dilatation
Study objectives	Cervical resistance during continuous controllable dilatation is highest in the zone of the internal orifice of the uterus (inner cervical os); the uterine cervix behaves as a sphincter during continuous controllable balloon dilatation.
Ethics approval(s)	Ethics Committee of Clinical Center Kragujevac, Serbia, 16/04/2013, ref: 01-4169.
Health condition(s) or problem(s) studied	Cervical resistance during continuous controllable balloon dilatation prior to termination of unwanted pregnancy.
Intervention	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.
Intervention type	Device
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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.
Secondary outcome measures	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
Overall study start date	01/05/2013
Completion date	01/05/2015

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	40 Years
Sex	Female
Target number of participants	42
Key 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
Key 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
Date of first enrolment	01/05/2013
Date of final enrolment	01/05/2014

Locations

Countries of recruitment

Serbia

Study participating centre

Clinical Center Kragujevac

22 Zmaj Jovina Street
Kragujevac
34000
Serbia

Sponsor information

Ministry of Education, Science and Technological Development (Serbia)
Government

Nemanjina street 22-26
Belgrade
11000
Serbia

Website	http://www.iii41007.fink.rs/index.php?option=com_jresearch&view=project&task=show&id=1&Itemid=63
"ROR"	https://ror.org/01znas443

Funders

Funder type

Government

Ministry of Education, Science and Technological Development (Serbia)

No information available

Results and Publications

Intention to publish date	12/12/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
Publication and dissemination plan	The results and conclusions of the study will be disseminated through scientific articles, scientific books, presentations and congress seminars. One article is about analysis of the cervical resistance measured by pressure sensitive films and is intended to be published by the end of this year. Another article is about sphincter qualities of the uterine cervix and is intended to be published by the end of this year.
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	28/10/2015		Yes	No