Continuous Controllable Balloon Dilation (CCBD): a novel approach for cervix dilatio

Completed

• Conditions: Cervical dilation; Pregnancy and Childbirth

• Registration Number: ISRCTN54007498
• Lead Sponsor: Clinical Center of Montenegro (Montenegro)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-21
• Last Update Posted: 20 November 2017

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tissue material for histology evaluation of cervical damage:<br>1. Epithelium damage (grade 0, 1, 2)<br>2. Basal membrane damage (grade 0, 1)<br>3. Stromal damage (grade 0, 1)<br>4. Cervical haemorrhagia (grade 0, 1, 2, 3)

Secondary Outcome Measures

Name	Time	Method
Semi-quantitative determination of tissue haemorrhagia