Double Foley Catheter For Cervical Ripening

Sponsor

Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04454346

Collaborator

(none)

222

Enrollment

Location

Arms

Actual Duration (Months)

54.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Induction of Labour	Device: Double Foley Catheter For Ripening The Unfavorable Cervix	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

222 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Jul 15, 2020

Actual Primary Completion Date :

Nov 1, 2020

Actual Study Completion Date :

Nov 15, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Women with term pregnancy,

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Etlik Zubeyde Hanim Woman's Health Care Training and Research Hospital	Ankara		Turkey	06010

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mehmet Obut, Medical Doctor, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

ClinicalTrials.gov Identifier:

NCT04454346

Other Study ID Numbers:

2020/06

First Posted:

Jul 1, 2020

Last Update Posted:

Jan 12, 2022

Last Verified:

Jan 1, 2022

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Mehmet Obut, Medical Doctor, Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital

Double Foley Catheter, Cook balloon, Foley catheter

Study Results

No Results Posted as of Jan 12, 2022