Second Trimester Pregnancy Termination With Foley Catheter

August 16, 2019 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

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

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).

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Recruiting
        • Kanuni SSTRH
        • Contact:
          • Berna Aslan Çetin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • singleton pregnancies
  • second trimester pregnancy ermination

Exclusion Criteria:

  • multiple pregnancies

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Foley catheter filled with 30 ml
The transcervical placement of the foley catheter will be performed and it will be filled with 30 ml saline. A gentle traction will be applied.
Device: Foley catheter
Transcervical foley catheter will be applied
ACTIVE_COMPARATOR: Foley catheter filled with 50 ml
The transcervical placement of the foley catheter will be performed and it will be filled with 50 ml saline. A gentle traction will be applied.
Device: Foley catheter
Transcervical foley catheter will be applied

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction abortus interval
Time Frame: up to five days
time to abortus will be recorded
up to five days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kanuni Sultan Suleyman Training and Research Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 15, 2018

Primary Completion (ANTICIPATED)

September 15, 2019

Study Completion (ANTICIPATED)

September 15, 2019

Study Registration Dates

First Submitted

May 9, 2018

First Submitted That Met QC Criteria

May 9, 2018

First Posted (ACTUAL)

May 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 20, 2019

Last Update Submitted That Met QC Criteria

August 16, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2018.4.18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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