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Cervical resistance during balloon dilatation

Analysis of cervical resistance during continuous controllable balloon dilatation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN30949871
Enrollment
42
Registered
2015-05-13
Start date
2013-05-01
Completion date
Unknown
Last updated
2016-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cervical resistance during continuous controllable balloon dilatation prior to termination of unwanted pregnancy. Not Applicable

Interventions

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 extensi

Sponsors

Ministry of Education, Science and Technological Development (Serbia)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Serbia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 4, 2026