Second Trimester Pregnancy Termination With Foley Catheter

NCT ID: NCT03532503

Last Updated: 2019-08-20

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-15

Study Completion Date

2019-09-15

Brief Summary

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One of the methods used to induce second trimester pregnancy termination is the placement of a transcervical Foley catheter. The aim of this randomized controlled study was to assess in pregnant women with an unfavourable cervix, whether there is a difference in efficacy between the two most commonly used insufflation volumes of Foley catheter (30mL and 50mL).

Detailed Description

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Conditions

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Pregnancy Termination

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Foley catheter filled with 30 ml

The transcervical placement of the foley catheter will be performed and it will be filled with 30 ml saline. A gentle traction will be applied.

Group Type ACTIVE_COMPARATOR

Foley catheter

Intervention Type DEVICE

Transcervical foley catheter will be applied

Foley catheter filled with 50 ml

The transcervical placement of the foley catheter will be performed and it will be filled with 50 ml saline. A gentle traction will be applied.

Group Type ACTIVE_COMPARATOR

Foley catheter

Intervention Type DEVICE

Transcervical foley catheter will be applied

Interventions

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Foley catheter

Transcervical foley catheter will be applied

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* singleton pregnancies
* second trimester pregnancy ermination

Exclusion Criteria

* multiple pregnancies
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

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

Locations

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Kanuni SSTRH

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Berna Aslan Cetin

Role: CONTACT

902124141500

Facility Contacts

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Berna Aslan Çetin

Role: primary

Other Identifiers

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2018.4.18

Identifier Type: -

Identifier Source: org_study_id

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