Foley Catheter vs Double-balloon Catheter

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