Foley Catheter vs Double-balloon Catheter

• Sponsor: Kanuni Sultan Suleyman Training and Research Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03521674
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Actual Duration (Months): 17.4
• Patients Per Site Per Month: 5.7

Study Details

Study Description

Brief Summary

The efficiency of double-balloon and Foley catheters in the second trimester medical termination of pregnancies will be compared.

Condition or Disease	Intervention/Treatment	Phase
Pregnancy Termination; Catheter	Device: pregnancy termination	N/A

Detailed Description

Women will be randomised into two groups. Foley catheter was applied to one group and double balloon catheter to the other group. After catheter expulsion or if the catheters did not spontaneously expulsed after 24 hours, i.v. oxytocin infusion will be started. Abortions will be considered successful if there will be no need of another method for abortion.

Study Design

• Study Type: Interventional
• Actual Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Foley Catheter and Double-balloon Catheter in Second Trimester Pregnancy Termination
• Actual Study Start Date: Dec 1, 2016
• Actual Primary Completion Date: May 15, 2018
• Actual Study Completion Date: May 15, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Foley catheter Foley catheter will be inserted through the cervical os and it will be filled with 40 ml saline. After insertion gentle traction will be applied for cervical ripening. Pregnancy termination will be achieved.	Device: pregnancy termination; Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done
Other: Double-balloon catheter Double-balloon catheter will be inserted through the cervical os and both baloons will be filled with 40 ml saline. No traction will be applied. Pregnancy termination will be achieved.	Device: pregnancy termination; Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done

Outcome Measures

Primary Outcome Measures

1. induction termination interval [during procedure]

   time from induction to pregnancy termination

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• pregnancy termination, gestational age from 14-24 weeks

Exclusion Criteria:

• multiple gestation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Kanuni SSTRH	Istanbul		Turkey

Sponsors and Collaborators

• Kanuni Sultan Suleyman Training and Research Hospital

Investigators

• Principal Investigator: Berna Aslan Çein, KSSTRH

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Berna Aslan Cetin, Md, ObGYN, Kanuni Sultan Suleyman Training and Research Hospital
• ClinicalTrials.gov Identifier: NCT03521674
• Other Study ID Numbers: 2016/8
• First Posted: May 11, 2018
• Last Update Posted: May 22, 2018
• Last Verified: May 1, 2018

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by Berna Aslan Cetin, Md, ObGYN, Kanuni Sultan Suleyman Training and Research Hospital: second trimester pregnancy termination; double-balloon catheter; foley catheter

Study Results

No Results Posted as of May 22, 2018