Cervical dilation Pregnancy and Childbirth Cervical dilation
Conditions
Interventions
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)
Grou
Sponsors
Clinical Center of Montenegro (Montenegro)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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) | — |
Secondary
| Measure | Time frame |
|---|---|
| Semi-quantitative determination of tissue haemorrhagia | — |
Countries
Montenegro
Outcome results
None listed