Skip to main content
OpenTrials
Completed

NCT Number: NCT04454346

Double Foley Catheter For Cervical Ripening

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Induction of Labour

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Etlik Zubeyde Hanim Woman's Health Care Training and Research Hospital

Ankara, 06010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women with term pregnancy,

Exclusion criteria

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

Treatment and study plan

Double Foley Catheter For Ripening The Unfavorable Cervix

Device

New method

Primary outcomes

  1. vaginal delivery within 24 hours

    Time frame: 24 hours

    the time from applying catheter to delivery

  2. ripening success

    Time frame: 12 hours

    Calculated soon after removal or spontaneous expulsion of catheters above 6 or increasing 2 point above baseline bishop score

  3. pain score

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Jul 1, 2020
Registry last updated
Jan 12, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.