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

NCT02842164 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2018-03-02

No results posted yet for this study

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.

Conditions

  • Induction of Abortion

Interventions

OTHER

Tension group

OTHER

No tension group

OTHER

Foley catheter Balloon

Sponsors & Collaborators

  • Assiut University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-07-31
Primary Completion
2017-08-31
Completion
2017-09-30

Countries

  • Egypt

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02842164 on ClinicalTrials.gov