Double Foley Catheter For Cervical Ripening

Induction of Labour Clinical Trial

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

Status Completed

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Induction of Labour

• NCT number: NCT04454346
• Study type: Interventional
• Source: Etlik Zubeyde Hanim Women's Health Care, Training and Research Hospital
• Status: Completed
• Phase: N/A
• Start date: July 15, 2020
• Completion date: November 15, 2020