Foley Catheter vs Double-balloon Catheter

Not Applicable

Completed

• Conditions: Catheter; Pregnancy Termination
• Interventions: Device: pregnancy termination

• Registration Number: NCT03521674
• Lead Sponsor: Kanuni Sultan Suleyman Training and Research Hospital

Brief Summary

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

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 Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2018-04-30
• Study First Submitted QC: 2018-04-30
• Status Verified: 2018-05
• Study First Posted: 2018-05-11
• Primary Completion: 2018-05-15
• Study Completion: 2018-05-15
• Last Update Submitted: 2018-05-19
• Last Update Posted: 2018-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• pregnancy termination, gestational age from 14-24 weeks

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Exclusion Criteria

• multiple gestation

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double-balloon catheter	pregnancy termination	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.
Foley catheter	pregnancy termination	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.

Primary Outcome Measures

Name	Time	Method
induction termination interval	during procedure	time from induction to pregnancy termination

Trial Locations

Locations (1)

Kanuni SSTRH; 🇹🇷 Istanbul, Turkey