Foley Catheter vs Double-balloon Catheter

May 19, 2018 updated by: Berna Aslan Cetin, Kanuni Sultan Suleyman Training and Research Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

100

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
        • Kanuni SSTRH

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

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • pregnancy termination, gestational age from 14-24 weeks

Exclusion Criteria:

  • multiple gestation

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: Foley catheter
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.
Device: pregnancy termination
Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done
OTHER: Double-balloon catheter
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.
Device: pregnancy termination
Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
induction termination interval
Time Frame: during procedure
time from induction to pregnancy termination
during procedure

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)

December 1, 2016

Primary Completion (ACTUAL)

May 15, 2018

Study Completion (ACTUAL)

May 15, 2018

Study Registration Dates

First Submitted

April 30, 2018

First Submitted That Met QC Criteria

April 30, 2018

First Posted (ACTUAL)

May 11, 2018

Study Record Updates

Last Update Posted (ACTUAL)

May 22, 2018

Last Update Submitted That Met QC Criteria

May 19, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2016/8

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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