NCT03532503

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2018

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
13 days until next milestone

First Posted

Study publicly available on registry

May 22, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2019

Completed
Last Updated

August 20, 2019

Status Verified

May 1, 2019

Enrollment Period

1.4 years

First QC Date

May 9, 2018

Last Update Submit

August 16, 2019

Conditions

Pregnancy Termination

Keywords

pregnancy terminationsecond trimesterfoley catheter

Outcome Measures

Primary Outcomes (1)

  • induction abortus interval

    time to abortus will be recorded

    up to five days

Study Arms (2)

Foley catheter filled with 30 ml

ACTIVE COMPARATOR

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.

Device: Foley catheter

Foley catheter filled with 50 ml

ACTIVE COMPARATOR

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.

Device: Foley catheter

Interventions

Foley catheterDEVICE

Transcervical foley catheter will be applied

Foley catheter filled with 30 mlFoley catheter filled with 50 ml

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • singleton pregnancies
  • second trimester pregnancy ermination

You may not qualify if:

  • multiple pregnancies

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni SSTRH

Istanbul, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Berna Aslan Cetin

CONTACT

902124141500bernaaslan14@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Md, ObGYN

Study Record Dates

First Submitted

May 9, 2018

First Posted

May 22, 2018

Study Start

April 15, 2018

Primary Completion

September 15, 2019

Study Completion

September 15, 2019

Last Updated

August 20, 2019

Record last verified: 2019-05

Locations

TU(1)