Comparison of Foley Catheter and Double-balloon Catheter in Second Trimester Pregnancy Termination
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- induction termination interval
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •pregnancy termination, gestational age from 14-24 weeks
Exclusion Criteria
- •multiple gestation
Arms & Interventions
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.
Intervention: pregnancy termination (Device)
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.
Intervention: pregnancy termination (Device)
Outcomes
Primary Outcomes
induction termination interval
Time Frame: during procedure
time from induction to pregnancy termination
Secondary Outcomes
No secondary outcomes reported
Investigators
Berna Aslan Cetin
Md, ObGYN
Kanuni Sultan Suleyman Training and Research Hospital