Foley Catheter vs Double-balloon Catheter

Pregnancy Termination Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03521674
• Other study ID #: 2016/8
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• Est. completion date: May 15, 2018

Study information

• Verified date: May 2018
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: May 15, 2018
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• pregnancy termination, gestational age from 14-24 weeks

Exclusion Criteria:

• multiple gestation

Related Conditions & MeSH terms

• Catheter
• Pregnancy Termination

Intervention

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

Locations

Country	Name	City	State
Turkey	Kanuni SSTRH	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Kanuni Sultan Suleyman Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	induction termination interval	time from induction to pregnancy termination	during procedure