Comparison of Misoprostol Ripening Efficacy With Dilapan

Status Completed

Clinical Trial Summary

The purpose of this study is to find out if Dilapan works as well as Misoprostol for preparing the mouth of the uterus (cervix) for inducing labor in women who need to undergo this procedure. The primary objective is to assess the efficacy of Dilapan for cervical ripening compared to Misoprostol in women undergoing Induction of labor (IOL) at or more than 37 weeks gestation.

Clinical Trial Description

In developed nations 25 % of pregnant women undergo labor induction for various indications. Likelihood of vaginal delivery depends on the degree of ripeness of cervix. Majority of women undergoing induction of labor are candidates for cervical ripening. Dilapan is an osmotic hygroscopic dilator of cervix commonly used for cervical preparation for mid trimester abortions. It has been proven safe for use for induction of Labor (IOL) at term. Misoprostol is a synthetic prostaglandin E1 analogue, widely used for cervical ripening and IOL in United States and is considered as standard of care. This is a non-inferiority, unblinded randomized, controlled trial where 322 eligible participants undergoing IOL at >37 weeks gestation and admitted to labor and delivery unit will be enrolled and randomly assigned in a ratio 1:1 to either receive Dilapan or Misoprostol for cervical ripening. After randomization all participants will undergo assessment as per standard of care. Participants will have either 1-5 Dilapan rods inserted into their cervix by the providers or receive 25 mcg of misoprostol orally every 2 hours to a maximum of 6 doses over 12 hours. Participants will be evaluated for artificial rupture of membranes and initiation of oxytocin for inducing uterine contraction. A diagnosis of failed IOL will be made if patient does not go into active labor within 24 hours after initiation of Oxytocin and Artificial Rupture Of Membranes (AROM). Intrapartum management will be according to institutional guidelines. All participants will be followed up and contacted by phone 2 weeks after discharge regarding their experience with the method of induction. ;

Study Design

Related Conditions & MeSH terms

Congenital Abnormalities
Induced; Birth
Labor Onset and Length Abnormalities

Clinical Trial Details

NCT number	NCT03670836
Study type	Interventional
Source	Columbia University
Contact
Status	Completed
Phase	Phase 4
Start date	November 15, 2018
Completion date	July 21, 2021

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT04017247` - Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor	N/A
Completed	`NCT05062343` - Cook Balloon vs Dilapan-S for Outpatient Cervical Ripening	N/A
Completed	`NCT02788305` - Effect of Maternal Obesity on Labour Induction in Postdate Pregnancy	N/A
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Completed	`NCT04645823` - Spinal Fentanyl or Epidural Analgesia in the Early First Phase of Induced Labor	Phase 4
Completed	`NCT04746248` - Outpatient Labor Induction Using Oral Misoprostol in Norway	N/A
Recruiting	`NCT05671224` - Visual Aids for Induction of Labor RCT	N/A
Completed	`NCT04756089` - Stimulation Therapy for Inducing Mothers	N/A
Recruiting	`NCT05798728` - Outpatient Transcervical Balloon For Induction of Labor	N/A
Withdrawn	`NCT04739683` - Cervical Ripening With Foley Bulb Versus Dilapan-S at Home	N/A
Not yet recruiting	`NCT04307199` - Membrane Sweeping to Prevent Post-term Pregnancy: The MILO Study	N/A
Completed	`NCT03725397` - Inpatient Versus Outpatient Foley Cervical Ripening Study	N/A
Recruiting	`NCT05719467` - SAINT: Safe Induction of Labor Trial	Phase 3
Completed	`NCT03113227` - Value of Measuring Cervical Angle and Length by Ultrasound in Prediction of Successful Induction of Delivery	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.

Comparison of Misoprostol Ripening Efficacy With Dilapan — COMRED

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms