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Cervical Ripening Interventions

This study has been terminated.
(Change in treatment plan for this population halted enrollment and project was terminated.)
Sponsor:
Information provided by (Responsible Party):
Loyola University
ClinicalTrials.gov Identifier:
NCT00383942
First received: October 2, 2006
Last updated: November 30, 2011
Last verified: November 2011
History of Changes
  Purpose

We wish to determine whether patients undergoing cervical ripening with an infusion of saline will have a lower c-section rate than patients who undergo cervical ripening with misoprostol.


Condition Intervention Phase
Induction of Labor
 Drug: Misoprostol
Procedure: Extra amniotic saline infusion
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Ripening Interventions: Prostaglandins vs. EASI Catheter

Resource links provided by NLM:

MedlinePlus related topics: Cesarean Section
Drug Information available for: Misoprostol
U.S. FDA Resources

Further study details as provided by Loyola University:

Primary Outcome Measures:
  • Proportion of women undergoing cesarean section for fetal intolerance of labor [ Time Frame: Delivery ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Apgar scores at 1 and 5 minutes [ Time Frame: 5 minutes ] [ Designated as safety issue: No ]
  • Neonatal intensive care unit admission [ Time Frame: Delivery ] [ Designated as safety issue: No ]
  • Incidence and characteristics of tachysystole [ Time Frame: During labor ] [ Designated as safety issue: Yes ]
  • Incidence and characteristics of hyperstimulation [ Time Frame: During and post delivery ] [ Designated as safety issue: Yes ]
  • Time to delivery [ Time Frame: delivery ] [ Designated as safety issue: No ]
  • Incidence of chorioamnionitis and endomyometritis [ Time Frame: 48 hours post delivery ] [ Designated as safety issue: Yes ]

Enrollment: 80
Study Start Date: July 2006
Study Completion Date: June 2008
Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Misoprostol
cervical ripening with Misoprostol ( 25 mcg every 4 hours)which is placed in the vagina.
 Drug: Misoprostol
Misoprostol,25 mcg every 4 hours.
Active Comparator: amniotic saline infusion
Extra amniotic saline infusion
 Procedure: Extra amniotic saline infusion
EASI catheter used for amniotic saline infusion.

Detailed Description:

The primary hypothesis is that patients undergoing cervical ripening with EASI (extra-amniotic saline infusion) catheter have a lower proportion of women who undergo cesarean section for fetal intolerance of labor as compared to misoprostol.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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

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
  Contacts and Locations
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: Loyola University
ClinicalTrials.gov Identifier: NCT00383942     History of Changes
Other Study ID Numbers: 109040
Study First Received: October 2, 2006
Last Updated: November 30, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Loyola University:
pregnancy
induction of labor

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

ClinicalTrials.gov processed this record on June 18, 2013