Double Foley Catheter For Cervical Ripening

NCT04454346 | Completed DMC

• 1 other identifier: 2020/06
• Study Type: interventional
• Target: 222
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Labour

Keywords

Double Foley Catheter, Cook balloon, Foley catheter

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (3)

Double Foley Catheter

EXPERIMENTAL

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

Single Foley Catheter

EXPERIMENTAL

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

Cook Balloon

EXPERIMENTAL

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

Interventions

Double Foley Catheter For Ripening The Unfavorable Cervix DEVICE

New method

Cook Balloon; Double Foley Catheter; Single Foley Catheter

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women with term pregnancy,

You may not qualify if:

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

Sponsors & Collaborators

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

Study Sites (1)

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

Ankara, 06010, Turkey (Türkiye)

Location

Study Officials

• Mehmet Obut, M.D

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 1, 2020
• Study Start: July 15, 2020
• Primary Completion: November 1, 2020
• Study Completion: November 15, 2020
• Last Updated: January 12, 2022

Record last verified: 2022-01

Locations

TU (1)