Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-03-01

Study Completion Date

2019-03-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Comparing 30mL Single Versus 80mL Double Balloon Catheters for Pre-induction Cervical Ripening

NCT02344459

Pre-induction Cervical Ripening

COMPLETED NA

Cervical Ripening Balloon for 12 Hours vs. 1 Hour.

NCT05922111

Induction of Labor

NOT_YET_RECRUITING NA

Cervix Uteri "Resistance" Measurements

NCT03948932

Induction of Labor Affected Fetus / Newborn

UNKNOWN

Membrane Stripping for Cervical Ripening

NCT06591247

Labor, Induced Cervical Ripening Balloon Induction +2 more

RECRUITING NA

Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix

NCT03752073

Induction of Labor

TERMINATED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This randomized controlled study is designed to:

1. To assess and compare the Bishop score when removing the DBD 12 hours' vs 6hours' after insertion.
2. To compare the efficacy (vaginal delivery rate and time to VD) in the two arm groups

200 women are expected to be randomized in to two arms. One will be randomized to DBD removal after 12 hours and the other to DBD removal after 6 hours.

Each patient will sign an informed consent.

The following screening will be completed: medical and gynecological history, general physical and gynecological examination, ultrasonography to exclude contraindication to vaginal delivery or insertion if the DBD and non stress test (NST) for baseline. Bishop score will be assessed.

After confirming eligibility for study, randomization into the following groups will take place.

Insertion of the DBD and removal 6 hours following its insertion. Insertion of the DBD and removal 12 hours following its insertion.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Induction of Labor Unfavorable Cervix

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

12 hours

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)

Group Type OTHER

cervical ripening device

Intervention Type DEVICE

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

6 hours

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)

Group Type ACTIVE_COMPARATOR

cervical ripening device

Intervention Type DEVICE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

cervical ripening device

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

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

atad double balloon device

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Parous patients 18 years of age or older.
2. Diagnosed to be parous pregnant women with an indication for induction of labour.
3. Having a Bishop score of 5 or less.
4. 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.
5. Willingness to comply with the protocol for the duration of the study.
6. Have signed the informed consent.

\-

Exclusion Criteria

1. A non -vertex presentation
2. Placenta previa
3. Ruptured membranes
4. Documented labour
5. Foetal distress necessitating immediate intervention
6. Proven malignancy of the cervix
7. Active inflammatory or purulent condition of the lower genital tract
8. Twin pregnancy
9. Any other contraindication for vaginal delivery

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes