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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

October 2, 2006
November 30, 2011
July 2006
June 2008   (final data collection date for primary outcome measure)
Proportion of women undergoing cesarean section for fetal intolerance of labor [ Time Frame: Delivery ] [ Designated as safety issue: No ]
Proportion of women undergoing cesarean section for fetal intolerance of labor
Complete list of historical versions of study NCT00383942 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Apgar scores at 1 and 5 minutes
  • Neonatal intensive care unit admission
  • Incidence and characteristics of tachysystole
  • Incidence and characteristics of hyperstimulation
  • Time to delivery
  • Incidence of chorioamnionitis and endomyometritis
Not Provided
Not Provided
 
Cervical Ripening Interventions
Ripening Interventions: Prostaglandins vs. EASI Catheter

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.

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.
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Induction of Labor
  • Drug: Misoprostol
    Misoprostol,25 mcg every 4 hours.
  • Procedure: Extra amniotic saline infusion
    EASI catheter used for amniotic saline infusion.
  • Active Comparator: Misoprostol
    cervical ripening with Misoprostol ( 25 mcg every 4 hours)which is placed in the vagina.
    Intervention: Drug: Misoprostol
  • Active Comparator: amniotic saline infusion
    Extra amniotic saline infusion
    Intervention: Procedure: Extra amniotic saline infusion

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
80
June 2008
June 2008   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00383942
109040
Not Provided
Loyola University
Loyola University
Not Provided
Principal Investigator: Scott Graziano, MD Loyola University
Loyola University
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP