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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02842164
Recruitment Status : Completed
First Posted : July 22, 2016
Last Update Posted : March 2, 2018
Information provided by (Responsible Party):
Mohammed Khairy Ali, Assiut University

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Induction of Abortion Other: Tension group Other: No tension group Other: Foley catheter Balloon Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : July 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : September 2017

Arm Intervention/treatment
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
Foley Catheter Balloon without tension group
The Foley catheter balloon will be just supported by simple taping to the thigh.
Other: No tension group
Other: Foley catheter Balloon

Primary Outcome Measures :
  1. The degree of pain provoked by catheter measured by visual analogue scale [ Time Frame: 6 hours ]

Secondary Outcome Measures :
  1. The time from insertion of Foley catheter balloon to catheter expulsion. [ Time Frame: 12 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02842164

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Women Health Hospital - Assiut university
Assiut, Egypt, 71111
Sponsors and Collaborators
Assiut University
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Responsible Party: Mohammed Khairy Ali, Dr, Assiut University Identifier: NCT02842164    
Other Study ID Numbers: FIOA
First Posted: July 22, 2016    Key Record Dates
Last Update Posted: March 2, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes