Double Foley Catheter For Cervical Ripening

Induction of Labour Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04454346
• Other study ID #: 2020/06
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Est. completion date: November 15, 2020

Study information

• Verified date: January 2022
• Source: Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 222
• Est. completion date: November 15, 2020
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women with term pregnancy,

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Induction of Labour

Intervention

Device:
• Double Foley Catheter For Ripening The Unfavorable Cervix
New method

Locations

Country	Name	City	State
Turkey	Etlik Zubeyde Hanim Woman's Health Care Training and Research Hospital	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vaginal delivery within 24 hours	the time from applying catheter to delivery	24 hours
Primary	ripening success	Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score	12 hours
Primary	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