Double Foley Catheter For Cervical Ripening

Double Foley Catheter For Ripening The Unfavorable Cervix: An Alternative Method

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.

Study Overview

• Status: Completed
• Conditions: Induction of Labour
• Intervention / Treatment: Device: Double Foley Catheter For Ripening The Unfavorable Cervix

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 Type: Interventional
• Enrollment (Actual): 222
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Ankara, Turkey, 06010
    • Etlik Zubeyde Hanim Woman's Health Care Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women with term pregnancy,

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Double Foley Catheter; The patients allocated to this arm were randomly and did not differ from the Single Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. The connected FCs were inserted into the cervix using long forceps and advanced to the internal os level. One of the Foley balloons was inflated with 80 ml of saline, and the other FC, now the cervicovaginal balloon, was pulled out with mild traction until the balloon could be visualized and inflated with 20 ml of saline. The vaginal speculum was removed, and the cervicovaginal balloon was inflated further to a total of 80 ml of saline. Both catheters were taped to the inner aspect of the thigh without tension	Device: Double Foley Catheter For Ripening The Unfavorable Cervix; New method
Experimental: Single Foley Catheter; The patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Cook Balloon arm regard to patients' demographic features and characteristics. a 16-F FC was inserted into the cervix using long forceps. Then, the balloon was inflated with 80 ml of saline using a standard 20 ml syringe. The catheter was then pulled out until the balloon covered the internal os. The speculum was removed, and the catheter was fixed under slight tension to the inner aspect of the thigh	Device: Double Foley Catheter For Ripening The Unfavorable Cervix; New method
Experimental: Cook Balloon; The patients allocated to this arm were randomly and did not differ from the Double Foley Catheter or Single Foley Catheter arm regard to patients' demographic features and characteristics. Cook cervical ripening group, the device was applied according to the manufacturer's instructions, and each balloon was inflated with 80 ml saline. The catheter was taped to the inner aspect of the thigh without tension.	Device: Double Foley Catheter For Ripening The Unfavorable Cervix; New method

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
vaginal delivery within 24 hours	the time from applying catheter to delivery	24 hours
ripening success	Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score	12 hours
pain score	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).	36 hours

Collaborators and Investigators

• Sponsor: Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
• Investigators: Study Director: Mehmet Obut, M.D, Etlik Zubeyde Hanim Woman Health's Care Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 15, 2020
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 15, 2020

Study Registration Dates

• First Submitted: June 28, 2020
• First Submitted That Met QC Criteria: June 28, 2020
• First Posted (Actual): July 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 8, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Double Foley Catheter, Cook balloon, Foley catheter
• Other Study ID Numbers: 2020/06

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No