Foley's Catheter Balloon for Induction of Mid Trimester Abortion in Nulliparous Women With or Without Tension Applied

February 28, 2018 updated by: Mohammed Khairy Ali, Assiut University

Induction of abortion is a hot subject that has complex and emotional controversy. The most common time of abortion is the second trimester which represent about 10-15% of all induced abortions over the world. As well as, two-thirds of all serious abortion-related complications are related to induced second trimester abortion.

There are many causes for induction of abortion in the second trimester such as missed abortion, serious fetal abnormalities such as central nervous system or skeletal malformation and lastly some women do not wish to continue a pregnancy and will often seek out termination of pregnancy.

Termination of second trimester is more risky than the first trimester. So many lines have been emerged to achieve safe and effective method of termination of second trimester.

Pharmacologic management seems to be an appealing method for induction of abortion. The combing between mifepristone and misoprostol is the effective regimen for termination of second trimester abortion with success rate reaching about 97-99% within 24 hours.

However, mifepristone is not available or affordable in many countries worldwide so misoprostol have been used alone but it needs higher total dose with lower effectiveness and higher percentage of side effects rate than the combined regimens.

The optimal method for inducing second trimester nulliparous women with an unfavorable cervix is not known. Several studies in literature have described the effectiveness of Foley's catheter in cervical ripening and improvement of Bishop's score in women with unripe cervices . It may act in addition to its mechanical effect by increasing the release of prostaglandin and/or oxytocin release secondary to localized inflammation.

In practice, the insertion of intra-cervical Foley's catheter balloon is followed by applying tension in trial to shorten the time between the insertion and expulsion of the fetus, however; this tension adds more pain for the pregnant women with higher rate of vaginal bleeding and dissatisfaction.

Gary et al in 2016 concluded that the application of tension did not result in faster delivery times, but did result in faster times to catheter expulsion.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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

  • Egypt
      • Assiut, Egypt, 71111
        • Women Health Hospital - Assiut university

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Singleton second trimester (12-28 weeks) pregnancy.
  • Nulliparous woman.
  • Bishop score ≤ 6.
  • BMI 18-22.5 kg/m2

Exclusion Criteria:

  • Multiple gestations.
  • Premature rupture of membranes before induction.
  • Pregnancy complicated by antepartum hemorrhage (placenta previa or abruptio placenta).
  • Low amniotic fluid volume (< 5cm).
  • Scarred uterus including hysterotomy or myomectomy.
  • Uterine infection.
  • Unexplained bleeding.
  • Latex allergy

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 Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Foley Catheter Balloon with Tension group
a 16 French transcervical Foley catheter balloon will be advanced to or past the internal os and the balloon will be filled. Then catheter will be placed on gentle traction by taping the distal tip to the medial thigh for maximum 24 hours. To maintain gentle traction, periodic repositioning of the distal tip on the thigh will be necessary.
Other: Tension group
Other: Foley catheter Balloon
Other: Foley Catheter Balloon without tension group
The Foley catheter balloon will be just supported by simple taping to the thigh.
Other: Foley catheter Balloon
Other: No tension group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The degree of pain provoked by catheter measured by visual analogue scale
Time Frame: 6 hours
6 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
The time from insertion of Foley catheter balloon to catheter expulsion.
Time Frame: 12 hours
12 hours

Collaborators and Investigators

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

Sponsor

Assiut University

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)

July 1, 2016

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

September 1, 2017

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 22, 2016

Study Record Updates

Last Update Posted (Actual)

March 2, 2018

Last Update Submitted That Met QC Criteria

February 28, 2018

Last Verified

February 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • FIOA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

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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