Second Trimester Pregnancy Termination With Foley Catheter

Pregnancy Termination Clinical Trial

Official title:

Second Trimester Pregnancy Termination With Foley Catheter With 30 ml vs 50 ml: Prospective Randomised Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03532503
• Other study ID #: 2018.4.18
• Status: Recruiting
• Phase: N/A
• Start date: April 15, 2018
• Est. completion date: September 15, 2019

Study information

• Verified date: May 2019
• Source: Kanuni Sultan Suleyman Training and Research Hospital
• Contact: Berna Aslan Cetin
• Phone: 902124141500
• Email: bernaaslan14[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

One of the methods used to induce second trimester pregnancy termination is the placement of a transcervical Foley catheter. The aim of this randomized controlled study was to assess in pregnant women with an unfavourable cervix, whether there is a difference in efficacy between the two most commonly used insufflation volumes of Foley catheter (30mL and 50mL).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 15, 2019
• Est. primary completion date: September 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• singleton pregnancies

• second trimester pregnancy ermination

Exclusion Criteria:

• multiple pregnancies

Related Conditions & MeSH terms

• Pregnancy Termination

Intervention

Device:
• Foley catheter
Transcervical foley catheter will be applied

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 abortus interval	time to abortus will be recorded	up to five days