Induction of Labour
Conditions
Keywords
Double Foley Catheter, Cook balloon, Foley catheter
Brief summary
To compare the efficacy of three mechanical devices for pre-induction of labour cervical ripening: the Single Foley Catheter, Double Foley Catheter (a new handmade device) and Cook cervical ripening balloon.
Detailed description
This prospective study Scheduled included 74 Double Foley Catheter, 74 Single Foley catheter group and 74 Cook cervical ripening catheter group. All pregnant women will be randomly allocated into three groups: the single Foley, Double Foley Catheter or Cook balloon catheter. Removal of the catheters is planned approximately 12 h after insertion if spontaneous expulsion occurred. The main outcome measures include changes in Bishop score, insertion to delivery time, mode of delivery and occurrence of adverse effects. Double Foley Catheter is a new method for cervical ripening that Two 18-Fr Foley catheters are connected with sterile suture from the hole end and where the balloons borders end. Both catheters are pushed above the internal cervical os the uterus. One of 18-Fr Foley catheter full with 80 mL of normal saline. The other Foley catheter is pulled into the vagina by applying traction and full with 80 mL of normal saline. The cervix between two balloons of Foley catheters exposed to pressure from both sides from the Foley catheter's balloon's similar to Cook balloon.
Interventions
DEVICEDouble Foley Catheter For Ripening The Unfavorable Cervix
New method
Sponsors
Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* Women with term pregnancy,
Exclusion criteria
* Breech presentations, previous cesarean section, Cephalopelvic disproportion, previous uterine scars, estimated fetal weight above 4500
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| vaginal delivery within 24 hours | 24 hours | the time from applying catheter to delivery |
| ripening success | 12 hours | Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score |
| pain score | 36 hours | The pain score during ripening phase which a visual analog scale is completed by the study population to assess the pain score during the entire ripening periods. The pain scores were assessed using the visual analog scale (where 0 = no pain and 10 = worst possible pain). |
Countries
Turkey (Türkiye)
Outcome results
None listed