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
  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:


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

ClinicalTrials.gov processed this record on October 23, 2014