NCT03045939

Brief Summary

This study will evaluate the insertion of double balloon device (DBD) for cervical ripening for 12 h vs 6 hours.

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 Mar 2017

Typical duration for not_applicable

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

First Submitted

Initial submission to the registry

January 24, 2017

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 8, 2017

Completed
21 days until next milestone

Study Start

First participant enrolled

March 1, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2019

Completed
Last Updated

March 5, 2019

Status Verified

March 1, 2019

Enrollment Period

1.9 years

First QC Date

January 24, 2017

Last Update Submit

March 3, 2019

Conditions

Induction of LaborUnfavorable Cervix

Keywords

cervical ripeninglabor inductiondouble balloon devicecervical ripening deviceunfavorable cervix

Outcome Measures

Primary Outcomes (1)

  • time from insertion of the DBD to delivery

    the time from insertion of the DBD until delivery will be assessed for each patient from each arm by hours/minutes

    minutes or hours from insertion to delivery, assessed up to an estimated total of 24 hours

Secondary Outcomes (2)

  • rate of vaginal delivery

    1 year

  • maternal and neonatal adverse events

    1 year

Study Arms (2)

12 hours

OTHER

This arm is the standard management that includes insertion of the DBD into the cervical canal according to manufacture guidelines, removal after 12 hours followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\\h)

Device: cervical ripening device

6 hours

ACTIVE COMPARATOR

Removal of the DBD after 6 hours, followed by artificial rupture of membranes and oxytocin infusion according to departments protocol. (a total of 10 units of oxytocin is infused, initiated with 10 cc/h, increased by 10cc every 20-30 min until 3-5 contractions are present, total of not more than 120 cc\\h)

Device: cervical ripening device

Interventions

cervical ripening deviceDEVICE

insertion of the double balloon device for 12 hours (standard care) vs 6 hours, following oxytocin IV infusion according local protocol guidelines as mentioned above

Also known as: atad double balloon device
12 hours6 hours

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parous patients 18 years of age or older.
  • Diagnosed to be parous pregnant women with an indication for induction of labour.
  • Having a Bishop score of 5 or less.
  • Diagnosed as having a singleton pregnancy in a vertex presentation, with intact membranes, and no significant regular uterine contraction at gestational age of 37 completed gestational weeks or more.
  • Willingness to comply with the protocol for the duration of the study.
  • Have signed the informed consent.

You may not qualify if:

  • A non -vertex presentation
  • Placenta previa
  • Ruptured membranes
  • Documented labour
  • Foetal distress necessitating immediate intervention
  • Proven malignancy of the cervix
  • Active inflammatory or purulent condition of the lower genital tract
  • Twin pregnancy
  • Any other contraindication for vaginal delivery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion Mc

Haifa, Israel

RECRUITING

Related Publications (2)

  • Sammour R, Dikopoltsev E, Sagi S, Vitner D, Bleicher I. Cervical ripening with a double balloon device for 6 h in patients with a long cervix: Secondary analysis of a randomized controlled trial. Int J Gynaecol Obstet. 2025 Mar;168(3):1055-1059. doi: 10.1002/ijgo.15955. Epub 2024 Oct 24.

    PMID: 39445570DERIVED

  • Bleicher I, Dikopoltsev E, Kadour-Ferro E, Sammour R, Gonen R, Sagi S, Eshel A, Nussam L, Vitner D. Double-Balloon Device for 6 Compared With 12 Hours for Cervical Ripening: A Randomized Controlled Trial. Obstet Gynecol. 2020 May;135(5):1153-1160. doi: 10.1097/AOG.0000000000003804.

    PMID: 32282603DERIVED

Central Study Contacts

Inna Bleicher, Dr

CONTACT

+972506268345innakreinin@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator Dr. Inna Bleicher

Study Record Dates

First Submitted

January 24, 2017

First Posted

February 8, 2017

Study Start

March 1, 2017

Primary Completion

February 1, 2019

Study Completion

March 1, 2019

Last Updated

March 5, 2019

Record last verified: 2019-03

Locations

IL(1)