NCT02842164

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 22, 2016

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

March 2, 2018

Status Verified

February 1, 2018

Enrollment Period

1.1 years

First QC Date

July 15, 2016

Last Update Submit

February 28, 2018

Conditions

Induction of Abortion

Outcome Measures

Primary Outcomes (1)

  • The degree of pain provoked by catheter measured by visual analogue scale

    6 hours

Secondary Outcomes (1)

  • The time from insertion of Foley catheter balloon to catheter expulsion.

    12 hours

Study Arms (2)

Foley Catheter Balloon with Tension group

OTHER

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 groupOther: Foley catheter Balloon

Foley Catheter Balloon without tension group

OTHER

The Foley catheter balloon will be just supported by simple taping to the thigh.

Other: No tension groupOther: Foley catheter Balloon

Interventions

Tension groupOTHER
Foley Catheter Balloon with Tension group
No tension groupOTHER
Foley Catheter Balloon without tension group
Foley catheter BalloonOTHER
Foley Catheter Balloon with Tension groupFoley Catheter Balloon without tension group

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

July 15, 2016

First Posted

July 22, 2016

Study Start

July 1, 2016

Primary Completion

August 1, 2017

Study Completion

September 1, 2017

Last Updated

March 2, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will share

Locations

EG(1)