Cervical Ripening Interventions

Induction of Labor Clinical Trial

Official title:

Ripening Interventions: Prostaglandins vs. EASI Catheter

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00383942
• Other study ID #: 109040
• Status: Terminated
• Phase: Phase 3
• First received: October 2, 2006
• Last updated: November 30, 2011
• Start date: July 2006
• Est. completion date: June 2008

Study information

• Verified date: November 2011
• Source: Loyola University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 80
• Est. completion date: June 2008
• Est. primary completion date: June 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induction of Labor

Intervention

Drug:
• Misoprostol
Misoprostol,25 mcg every 4 hours.

Procedure:
• Extra amniotic saline infusion
EASI catheter used for amniotic saline infusion.

Locations

Country	Name	City	State
United States	Loyola University Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

References & Publications (3)

Afolabi BB, Oyeneyin OL, Ogedengbe OK. Intravaginal misoprostol versus Foley catheter for cervical ripening and induction of labor. Int J Gynaecol Obstet. 2005 Jun;89(3):263-7. Epub 2005 Apr 2. — View Citation

Johnson DP, Davis NR, Brown AJ. Risk of cesarean delivery after induction at term in nulliparous women with an unfavorable cervix. Am J Obstet Gynecol. 2003 Jun;188(6):1565-9; discussion 1569-72. — View Citation

Karjane NW, Brock EL, Walsh SW. Induction of labor using a foley balloon, with and without extra-amniotic saline infusion. Obstet Gynecol. 2006 Feb;107(2 Pt 1):234-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of women undergoing cesarean section for fetal intolerance of labor		Delivery	No
Secondary	Apgar scores at 1 and 5 minutes		5 minutes	No
Secondary	Neonatal intensive care unit admission		Delivery	No
Secondary	Incidence and characteristics of tachysystole		During labor	Yes
Secondary	Incidence and characteristics of hyperstimulation		During and post delivery	Yes
Secondary	Time to delivery		delivery	No
Secondary	Incidence of chorioamnionitis and endomyometritis		48 hours post delivery	Yes