Cervical Ripening Balloon for 12 Hours vs. 1 Hour.

Status Not yet recruiting

Clinical Trial Summary

The aim of this study is a comparison of induction of labor with a cervical ripening balloon left in place for one hour compared to twelve hours. The primary outcome is time to delivery. Women admitted for induction of labor will be recruited and randomized to either a cervical ripening balloon for one hour or twelve hours. the management of delivery after the extraction of the balloon will be left to the discretion of the attending physician.

Clinical Trial Description

The common IOL techniques used for pregnant women with unfavorable cervix might be specified to either mechanical induction via cervical ripening balloon (CRB) or pharmacological induction. The insertion of a CRB is believed to mechanically ripen the uterine cervix with a better safety profile than prostaglandins. The duration of the balloon placement varied considerably, and it was commonly placed for 12-24 hours. Nevertheless, recent randomized controlled studies have demonstrated favorable results following only 6 hours of CRB placement with or without additional administration of oxytocin. We believe that mechanical ripening of the cervix can be achieved even less than six hours. Our study aims to evaluate the time to delivery and pregnancy outcomes after placement of CRB of only 1 hour compared to either 6 or 12 hours. Study Protocol: 1. Women planned for induction of labor will be approached by a trained resident and will sign informed consent. 2. All participants will be randomized to either one hour or twelve hours CRB placement using a computer program randomization scheme, block size of 20, by the department research coordinator who will keep the sequential in sealed envelopes. 3. Demographic parameters will be retrieved from the computerized database of Rambam Medical Center (RMC). 4. Eligible women will undergo the usual procedure of CRB insertion using a double lumen Cook cervical ripening balloon (CCRB). The CRB will be removed approximately after an hour in the intervention group and after twelve hours in the control group. Thereafter, the women will proceed amniotomy or Pitocin use at the discretion of the labor and delivery physician ;

Study Design

Related Conditions & MeSH terms

Induction of Labor

Clinical Trial Details

NCT number	NCT05922111
Study type	Interventional
Source	Rambam Health Care Campus
Contact	Naphtali Justman
Phone	0546836644
Email	njustman88@gmail.com
Status	Not yet recruiting
Phase	N/A
Start date	August 1, 2023
Completion date	June 30, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT01127581` - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery	Phase 3
Completed	`NCT01139801` - Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon	N/A
Active, not recruiting	`NCT06324279` - Cervical Sliding Sign to Predict Outcome of Induction of Labor
Recruiting	`NCT05864326` - Heated Saline in Cervical Balloon for Labor Induction, a RCT	N/A
Active, not recruiting	`NCT06056141` - Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter	Phase 4
Completed	`NCT04529837` - Ultrasound Assessment of DILAPAN-S
Completed	`NCT02477085` - Methods of Labor Induction and Perinatal Outcomes
Completed	`NCT03138252` - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin	Phase 3
Completed	`NCT02098421` - Foley Labor Induction Trial at Term and in PROM	Phase 1
Recruiting	`NCT01720394` - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert	Phase 4
Completed	`NCT00451308` - Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml	Phase 4
Not yet recruiting	`NCT05511727` - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening	N/A
Recruiting	`NCT02762942` - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor	Phase 4
Completed	`NCT01283022` - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study)	Phase 2
Recruiting	`NCT00684606` - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor	N/A
Recruiting	`NCT05759364` - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain	N/A
Recruiting	`NCT03854383` - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women	Phase 2
Completed	`NCT01428037` - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor	Phase 3
Terminated	`NCT03752073` - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix	N/A
Recruiting	`NCT03045939` - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.