Induction of Labor, Unfavorable Cervix
Conditions
Keywords
cervical ripening, labor induction, double balloon device, cervical ripening device, unfavorable cervix
Brief summary
This study will evaluate the insertion of double balloon device (DBD) for cervical ripening for 12 h vs 6 hours.
Detailed description
This randomized controlled study is designed to: 1. To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion. 2. To compare the efficacy (vaginal delivery rate and time to VD) in the two arm groups 200 women are expected to be randomized in to two arms. One will be randomized to DBD removal after 12 hours and the other to DBD removal after 6 hours. Each patient will sign an informed consent. The following screening will be completed: medical and gynecological history, general physical and gynecological examination, ultrasonography to exclude contraindication to vaginal delivery or insertion if the DBD and non stress test (NST) for baseline. Bishop score will be assessed. After confirming eligibility for study, randomization into the following groups will take place. Insertion of the DBD and removal 6 hours following its insertion. Insertion of the DBD and removal 12 hours following its insertion.
Interventions
DEVICEcervical ripening device
insertion of the double balloon device for 12 hours (standard care) vs 6 hours, following oxytocin IV infusion according local protocol guidelines as mentioned above
Sponsors
Bnai Zion Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Parous patients 18 years of age or older. 2. Diagnosed to be parous pregnant women with an indication for induction of labour. 3. Having a Bishop score of 5 or less. 4. Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of 37 completed gestational weeks or more. 5. Willingness to comply with the protocol for the duration of the study. 6. Have signed the informed consent. \-
Exclusion criteria
1. A non -vertex presentation 2. Placenta previa 3. Ruptured membranes 4. Documented labour 5. Foetal distress necessitating immediate intervention 6. Proven malignancy of the cervix 7. Active inflammatory or purulent condition of the lower genital tract 8. Twin pregnancy 9. Any other contraindication for vaginal delivery
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| time from insertion of the DBD to delivery | minutes or hours from insertion to delivery, assessed up to an estimated total of 24 hours | the time from insertion of the DBD until delivery will be assessed for each patient from each arm by hours/minutes |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rate of vaginal delivery | 1 year | calculation of the rate of vaginal delivery in each arm will be calculated by number of Vaginal deliveries in each arm and the percentage. |
| maternal and neonatal adverse events | 1 year | — |
Countries
Israel
Contacts
Primary ContactInna Bleicher, Dr
Outcome results
None listed