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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Aultman Health Foundation
ClinicalTrials.gov Identifier:
NCT01139801
First received: June 7, 2010
Last updated: January 6, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Induction of Labor
Drug: Oxytocin
Drug: Misoprostol

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Aultman Health Foundation:

Primary Outcome Measures:
  • Induction Time [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    To assess effectiveness of misoprostol used in conjunction with Foley balloon versus the standard oxytocin regimen in regards to induction times (induction-to-delivery, active labor-to-delivery and induction-to-ripening)


Secondary Outcome Measures:
  • Delivery Route [ Time Frame: 24 hrs ] [ Designated as safety issue: No ]
    To assess for differences in delivery routes


Enrollment: 50
Study Start Date: September 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oxytocin
Foley balloon placement with intravenous low dose oxytocin administration
Drug: Oxytocin
Foley balloon placement with intravenous low dose oxytocin administration
Experimental: Misoprostol
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement
Drug: Misoprostol
Misoprostol, 25 mcg, is placed intravaginally into the posterior fornix of the vagina in conjunction with Foley balloon placement

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT01139801

Locations
United States, Ohio
Aultman Health Foundation
Canton, Ohio, United States, 44710
Sponsors and Collaborators
Aultman Health Foundation
Investigators
Principal Investigator: Erica Downey, MD Aultman Health Foundation
  More Information

No publications provided

Responsible Party: Aultman Health Foundation
ClinicalTrials.gov Identifier: NCT01139801     History of Changes
Other Study ID Numbers: 2009 ED
Study First Received: June 7, 2010
Last Updated: January 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Aultman Health Foundation:
Cervical Ripening
Rate of Cesearean Section

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

ClinicalTrials.gov processed this record on September 18, 2014