Foley Catheter vs Double-balloon Catheter

K

Kanuni Sultan Suleyman Training and Research Hospital

Status

Completed

Conditions

Pregnancy Termination
Catheter

Treatments

Device: pregnancy termination

Study type

Interventional

Funder types

Other

Identifiers

NCT03521674
2016/8

Details and patient eligibility

About

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

Full 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.

Enrollment

100 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • pregnancy termination, gestational age from 14-24 weeks

Exclusion criteria

  • multiple gestation

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

100 participants in 2 patient groups

Foley catheter
Other group
Description:
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.
Treatment:
Device: pregnancy termination
Double-balloon catheter
Other group
Description:
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.
Treatment:
Device: pregnancy termination

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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