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Ripening Interventions: Prostaglandins vs EASI Catheter (RIPE)

This study has been terminated.
(Change in treatment plan for this population terminated the project)
Sponsor:
Information provided by (Responsible Party):
Scott Graziano, Loyola University
ClinicalTrials.gov Identifier:
NCT00383942
First received: October 2, 2006
Last updated: January 23, 2017
Last verified: January 2017
  Purpose
The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.

Condition Intervention Phase
Cesarean Section
Drug: Misoprostol
Device: Catheter
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: The RIPE Study: Ripening Interventions: Prostaglandins vs EASI Catheter

Resource links provided by NLM:


Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor [ Time Frame: At time of delivery ]
    The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.


Enrollment: 80
Actual Study Start Date: August 31, 2006
Study Completion Date: June 18, 2008
Primary Completion Date: June 18, 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Misoprostol
Patients randomized to this arm will receive 25 micrograms of misoprostol every four hours.
Drug: Misoprostol
Misoprostol,25 micrograms every 4 hours.
Other Name: Cytotec
Experimental: EASI Catheter
Patients randomized to this arm will receive extra amniotic saline infusion (EASI) administered via catheter
Device: Catheter
A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen
Other Name: EASI

Detailed Description:

Induction of labor is a common obstetrical practice. In fact, the rate of induction has risen to 184/1000 live births. It is well known that a favorable Bishop score, defined as Bishop score 5-8, improves the safety and success rate for induction of labor and vaginal delivery. Several methods for cervical ripening, both mechanical and pharmacological, have been developed to improve Bishop score in women eligible for induction of labor with an unfavorable cervix. These methods include: misoprostol, dinoprostone, intracervical catheter with and without extra-amniotic saline infusion, and laminaria.

Several studies have investigated the optimum cervical ripening agent, and review of current literature supports that misoprostol given in a dose of 25 micrograms every 4 hours intravaginally as the most efficacious and inexpensive regimen while maintaining safe maternal and fetal outcomes. Several studies have shown that misoprostol has a significantly shorter time to delivery compared with other methods of ripening. In fact, in a 2003 Cochrane Database Systematic Review, misoprostol was shown to have increased cervical ripening effectiveness and reduced failure to achieve vaginal delivery in 12-24 hours. Further, while uterine hyper-stimulation and tachysystole were more common in the misoprostol groups, no adverse neonatal outcomes were described. However, misoprostol has been shown to have a higher incidence of cesarean section for fetal intolerance to labor compared to other cervical ripening methods including EASI. Several studies support the ideal route of administration and dosage of misoprostol to be 25 micrograms every 4 hours intravaginally. This regimen leads to effective cervical ripening while reducing the dose-dependent effect of misoprostol on uterine tachysystole and hyperstimulation. Another aspect to consider in cervical ripening method is cost. Misoprostol is much less expensive than other methods including dinoprostone. In fact, one article reports that the average cost per patient for misoprostol treatment was $85 compared to $606 for dinoprostone insert.

Extra-amniotic saline infusion (EASI) has been introduced as a mechanical, non-pharmacological cervical ripening method. It involves placement of a Foley catheter through the cervix and is supplemented with continuous extra-amniotic infusion of saline. This is thought to improve prostaglandin release, resulting in shortened duration of labor. Several studies have been performed to determine the safety and efficacy of the EASI method.

Since misoprostol is efficacious, safe, and inexpensive, it is a superior method for cervical ripening and will act as a control for an experimental group undergoing cervical ripening with the EASI catheter. Our hypothesis is that cervical ripening with the EASI method will result in fewer cesarean sections for fetal intolerance to labor as compared to misoprostol. Furthermore, patients undergoing cervical ripening with EASI will experience a shorter time to delivery, have less expense, have fewer adverse effects, and will be more satisfied with EASI catheter than with misoprostol.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy
  • Cephalic presentation
  • 36 completed weeks of gestation
  • Intact membranes
  • Unfavorable cervix (defined as Bishop score < 5)
  • Indication for induction of labor
  • Fetal Station less than or equal to -3

Exclusion Criteria:

  • Clinically significant vaginal bleeding
  • Evidence of spontaneous labor (3 contractions in 10 minutes)
  • Contraindication to induction of labor or to use of prostaglandins
  • Fetal station higher than -3
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00383942

Locations
United States, Illinois
Loyola University Medical Center
Maywood, Illinois, United States, 60153
Sponsors and Collaborators
Loyola University
Investigators
Principal Investigator: Scott Graziano, MD Loyola University
  More Information

Publications:

Responsible Party: Scott Graziano, Associate Professor, Loyola University
ClinicalTrials.gov Identifier: NCT00383942     History of Changes
Other Study ID Numbers: 109040
Study First Received: October 2, 2006
Results First Received: June 1, 2016
Last Updated: January 23, 2017
Individual Participant Data  
Plan to Share IPD: No
Plan Description: There is no plan to share individual participant data

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Loyola University:
Pregnancy
Extra amniotic saline infusion
Misoprostol
Labor induction

Additional relevant MeSH terms:
Misoprostol
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics

ClinicalTrials.gov processed this record on May 23, 2017