Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
222 participants
INTERVENTIONAL
2020-07-15
2020-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
OTHER
QUADRUPLE
Study Groups
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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
Double Foley Catheter For Ripening The Unfavorable Cervix
New method
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
Double Foley Catheter For Ripening The Unfavorable Cervix
New method
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.
Double Foley Catheter For Ripening The Unfavorable Cervix
New method
Interventions
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Double Foley Catheter For Ripening The Unfavorable Cervix
New method
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
40 Years
FEMALE
No
Sponsors
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Etlik Zubeyde Hanım Women's Health Care, Training and Research Hospital
OTHER
Responsible Party
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Mehmet Obut
Medical Doctor
Principal Investigators
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Mehmet Obut, M.D
Role: STUDY_DIRECTOR
Etlik Zubeyde Hanim Woman Health's Care Training and Research Hospital
Locations
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Etlik Zubeyde Hanim Woman's Health Care Training and Research Hospital
Ankara, , Turkey (Türkiye)
Countries
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Other Identifiers
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2020/06
Identifier Type: -
Identifier Source: org_study_id
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