Foley Catheter vs Double-balloon Catheter

NCT ID: NCT03521674

Last Updated: 2018-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-01

Study Completion Date

2018-05-15

Brief Summary

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

Detailed Description

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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.

Conditions

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Pregnancy Termination Catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

pregnancy termination

Intervention Type DEVICE

Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done

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.

Group Type OTHER

pregnancy termination

Intervention Type DEVICE

Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done

Interventions

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pregnancy termination

Second trimester pregnancy termination for fetal anomali or in utero mord fetus will be done

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* pregnancy termination, gestational age from 14-24 weeks

Exclusion Criteria

* multiple gestation
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kanuni Sultan Suleyman Training and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Berna Aslan Cetin

Md, ObGYN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Berna Aslan Çein

Role: PRINCIPAL_INVESTIGATOR

KSSTRH

Locations

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Kanuni SSTRH

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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2016/8

Identifier Type: -

Identifier Source: org_study_id

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