Clinical Trials Logo
  1. Home
  2. Induction of Labor
  3. NCT01139801
  4. Details
NCT01139801 Clinical Trial

Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

Induction of Labor Clinical Trial

Official title:
Cervical Ripening for Induction of Labor: Misoprostol Versus Oxytocin in Conjunction With Foley Balloon

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01139801
Other study ID # 2009 ED
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2009
Est. completion date March 2010

Study information
Verified date August 2018
Source Aultman Health Foundation
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to specifically investigate the efficacy of an alternative pharmacologic cervical ripening agent, misoprostol, versus the standard oxytocin, as an adjunct to Foley balloon for induction of the unfavorable cervix.

Description:

The design of this study is a randomized, controlled study with two arms. Both groups will undergo placement of a Foley catheter, through the external and internal os of the cervix, according to standard practice. In group A, receiving intravenous infusion of oxytocin, will serve as the control group as it is standard protocol at Aultman Hospital. Group B, intravaginal placement of misoprostol, will serve as the experimental group. The expected duration of participation begins at induction of labor and concludes at time of delivery.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Participant or surrogate is capable of giving informed consent

- Anticipated number - 50 patients with 25 in each study arm Female with singleton gestation, live intrauterine pregnancy

- Participant is undergoing an indicated induction of labor

- Participant is found to have cervical Bishop score =5 on initial cervical exam

- Participant has no medical or obstetrical contraindications to induction of labor

Exclusion Criteria:

- Participant has =2 painful contractions in 10 min in 2 subsequent 10 min periods

- Manufacturer's contraindications to misoprostol or oxytocin

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Oxytocin
Foley balloon placement with intravenous low dose oxytocin administration starting 2 milliunits per minute.
• Misoprostol
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement

Locations
Country Name City State
United States Aultman Health Foundation Canton Ohio

Sponsors (1)
Lead Sponsor Collaborator
Aultman Health Foundation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Rate of Induction To Delivery To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times 24 hrs
Secondary Delivery Route To assess for differences in delivery routes 24 hrs
See also
  Status Clinical Trial Phase
Completed NCT01127581 - Efficacy & Safety Study Comparing Misoprostol Vaginal Insert (MVI) Versus Dinoprostone Vaginal Insert (DVI) for Reducing Time to Vaginal Delivery Phase 3
Active, not recruiting NCT06324279 - Cervical Sliding Sign to Predict Outcome of Induction of Labor
Recruiting NCT05864326 - Heated Saline in Cervical Balloon for Labor Induction, a RCT N/A
Active, not recruiting NCT06056141 - Induction of Labour at Term With Low Dose Oral Misoprostol Versus a Foley Catheter Phase 4
Completed NCT04529837 - Ultrasound Assessment of DILAPAN-S
Completed NCT02477085 - Methods of Labor Induction and Perinatal Outcomes
Completed NCT03138252 - Study of the Effectiveness of Cervical Ripening Balloon With and Without Oxytocin Phase 3
Completed NCT02098421 - Foley Labor Induction Trial at Term and in PROM Phase 1
Recruiting NCT01720394 - Efficacy of Induction of Labor on Term Using a Double Balloon Catheter Compared to Dinoprostone Vaginal-insert Phase 4
Completed NCT00451308 - Induction of Labor With a Foley Balloon Catheter: Inflation With 30ml Compared to 60ml Phase 4
Not yet recruiting NCT05511727 - Use of Single Versus Double Foley's Catheter in Pre-induction Cervical Ripening N/A
Recruiting NCT02762942 - Comparison of Vaginal Misoprostol Plus Supracervical Balloon Versus Vaginal Misoprostol Alone for Induction of Labor Phase 4
Completed NCT01283022 - Pharmacokinetic (PK) Study of the 200 Microgram (mcg) Misoprostol Vaginal Insert (MVI 200) in Women at Term Gestation (The MVI-PK Study) Phase 2
Recruiting NCT00684606 - Transcervical Foley Catheter With or Without Oxytocin for Induction of Labor N/A
Recruiting NCT05759364 - The Effect of IV PAPAVERINE 80 mg Prior to Catheter Balloon Insertion on Bishop Score and Pain N/A
Recruiting NCT03854383 - Using Isosorbide Mononitrate in Reducing Time in Induction of Labor in Post Date Women Phase 2
Completed NCT01428037 - Safety and Efficacy Study of Vaginal Misoprostol for Cervical Ripening and Induction of Labor Phase 3
Terminated NCT03752073 - Comparison of Two Mechanical Methods of Outpatient Ripening of the Cervix N/A
Recruiting NCT03045939 - Cervical Ripening With the Double Balloon Device for 6 Hours Compared With 12 Hours N/A
Completed NCT03976037 - Buccal Versus Vaginal Misoprostol In Combination With Foley Bulb Early Phase 1