NCT03521674

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2016

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

April 30, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
4 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2018

Completed
Last Updated

May 22, 2018

Status Verified

May 1, 2018

Enrollment Period

1.5 years

First QC Date

April 30, 2018

Last Update Submit

May 19, 2018

Conditions

Pregnancy TerminationCatheter

Keywords

second trimester pregnancy terminationdouble-balloon catheterfoley catheter

Outcome Measures

Primary Outcomes (1)

  • induction termination interval

    time from induction to pregnancy termination

    during procedure

Study Arms (2)

Foley catheter

OTHER

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.

Device: pregnancy termination

Double-balloon catheter

OTHER

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.

Device: pregnancy termination

Interventions

pregnancy terminationDEVICE

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

Double-balloon catheterFoley catheter

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailssecond trimester pregnancies
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • pregnancy termination, gestational age from 14-24 weeks

You may not qualify if:

  • multiple gestation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni SSTRH

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Abortion, Induced

Intervention Hierarchy (Ancestors)

Obstetric Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Berna Aslan Çein

    KSSTRH

    PRINCIPAL INVESTIGATOR

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
Md, ObGYN

Study Record Dates

First Submitted

April 30, 2018

First Posted

May 11, 2018

Study Start

December 1, 2016

Primary Completion

May 15, 2018

Study Completion

May 15, 2018

Last Updated

May 22, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)