NCT03016442

Brief Summary

Effıcacy of dinoprostone vaginal insert versus double- balloon catheter among women in the induction of labor

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 phase_2

Timeline
Completed

Started Nov 2016

Shorter than P25 for phase_2

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 8, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 10, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

January 10, 2017

Status Verified

November 1, 2016

Enrollment Period

5 months

First QC Date

January 8, 2017

Last Update Submit

January 9, 2017

Conditions

Labor Induction

Keywords

Double balloon catheterDinoprostoneLabor induction

Outcome Measures

Primary Outcomes (1)

  • Vaginal delivery after initiation of ripening within 24 hours

    24 hours

Secondary Outcomes (1)

  • Occurence of cesarean section

    24 hours

Study Arms (2)

Cook double balloon catheter

EXPERIMENTAL

A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination İt is placed for 12 hours

Device: Cook Double Balloon Catheter

Dinoprostone

ACTIVE COMPARATOR

10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.

Drug: Dinoprostone

Interventions

Cook Double Balloon CatheterDEVICE

A double- balloon catheter (Cook Cervical Ripener Balloon,Cook OB/GYN,Spencer IN) is inserted into cervical canal under direct visualisation during a sterile speculum examination.İt is placed for 12 hours

Also known as: The Obstetric Cook Double Balloon Catheter
Cook double balloon catheter
DinoprostoneDRUG

10 mg of dinoprostone in a hydrogel insert is placed high in the vaginal fornix. İt is placed for 12 hours.It is a controlled release formulation which has been found to release dinoprostone in vivo at a rate of approximately 0.3 mg/hr.

Also known as: Dinoprostone vaginal insert
Dinoprostone

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Eligible women have obstetric or medical indications for labor induction with intact membranes
  • singleton pregnancies,
  • vertex presentations
  • low Bishop scores ≤6
  • gestational age ≥34 w
  • reassuring fetal heart tracing on admission.

You may not qualify if:

  • unexplained vaginal bleeding
  • nonvertex presentation
  • intrauterine fetal death
  • prior cesarean delivery
  • any scarred uterus
  • any other contraindications for vaginal delivery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kanuni Sultan Süleyman Eğitim ve Araştırma Hastanesi

Istanbul, 34325, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Cromi A, Ghezzi F, Uccella S, Agosti M, Serati M, Marchitelli G, Bolis P. A randomized trial of preinduction cervical ripening: dinoprostone vaginal insert versus double-balloon catheter. Am J Obstet Gynecol. 2012 Aug;207(2):125.e1-7. doi: 10.1016/j.ajog.2012.05.020. Epub 2012 Jun 1.

    PMID: 22704766BACKGROUND

  • Connolly KA, Kohari KS, Rekawek P, Smilen BS, Miller MR, Moshier E, Factor SH, Stone JL, Bianco AT. A randomized trial of Foley balloon induction of labor trial in nulliparas (FIAT-N). Am J Obstet Gynecol. 2016 Sep;215(3):392.e1-6. doi: 10.1016/j.ajog.2016.03.034. Epub 2016 Mar 24.

    PMID: 27018464BACKGROUND

  • de Vaan MD, Ten Eikelder ML, Jozwiak M, Palmer KR, Davies-Tuck M, Bloemenkamp KW, Mol BWJ, Boulvain M. Mechanical methods for induction of labour. Cochrane Database Syst Rev. 2023 Mar 30;3(3):CD001233. doi: 10.1002/14651858.CD001233.pub4.

    PMID: 36996264DERIVED

Related Links

MeSH Terms

Interventions

Dinoprostone

Intervention Hierarchy (Ancestors)

Prostaglandins EProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Central Study Contacts

Gonca Yetkin Yıldırım, MD

CONTACT

+90 5323532205goncayetkinyildirim@gmail.com

Nadiye Köroğlu, MD

CONTACT

+90 5058065348nadiye_dugan@hotmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

January 8, 2017

First Posted

January 10, 2017

Study Start

November 1, 2016

Primary Completion

April 1, 2017

Study Completion

April 1, 2017

Last Updated

January 10, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)