Double Foley Catheter For Cervical Ripening

Not Applicable

Completed

• Conditions: Induction of Labour

• Registration Number: NCT04454346
• Lead Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

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.

Study Timeline

• Study First Submitted: 2020-06-28
• Study First Submitted QC: 2020-06-28
• Study First Posted: 2020-07-01
• Study Start: 2020-07-15
• Primary Completion: 2020-11-01
• Study Completion: 2020-11-15
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-08
• Last Update Posted: 2022-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 222

Inclusion Criteria

• Women with term pregnancy,

Exclusion Criteria

• Breech presentations, previous cesarean section, Cephalopelvic disproportion, previous uterine scars, estimated fetal weight above 4500

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Primary Outcome Measures

Name	Time	Method
vaginal delivery within 24 hours	24 hours	the time from applying catheter to delivery
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).
ripening success	12 hours	Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score

Trial Locations

Locations (1)

Etlik Zubeyde Hanim Woman's Health Care Training and Research Hospital; 🇹🇷 Ankara, Turkey