Foley Catheter vs Double-balloon Catheter

NCT03521674 — Not applicable, Completed, 100 participants, Kanuni Sultan Suleyman Training and Research Hospital

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Comparison of Foley Catheter and Double-balloon Catheter in Second Trimester Pregnancy Termination

Registry	NCT03521674
Status	Completed
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	100 (Actual)
Sponsor	Kanuni Sultan Suleyman Training and Research Hospital (Other)
Conditions	Pregnancy Termination, Catheter
Interventions	pregnancy termination (Device)
Dates	start 2016-12-01, primary completion 2018-05-15, completion 2018-05-15, first posted 2018-05-11, last updated 2018-05-22
Locations	1 site in Turkey (Türkiye)

-Summary

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

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Foley catheter	Other	Device: 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.
Double-balloon catheter	Other	Device: 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.

pregnancy termination (Device): Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done

+Outcome measures

Primary outcomes

induction termination interval [during procedure]: time from induction to pregnancy termination

+Eligibility

Sex: Female, ages: 18 Years to 40 Years, accepts healthy volunteers

Inclusion Criteria:

* pregnancy termination, gestational age from 14-24 weeks

Exclusion Criteria:

* multiple gestation

+Locations (1)

Facility	City	Country	Status
Kanuni SSTRH	Istanbul	Turkey (Türkiye)

+Investigators

Berna Aslan Çein, Principal investigator, KSSTRH