Comparison of Pre-Induction Cervical Ripening

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of South Carolina
ClinicalTrials.gov Identifier:
NCT01390233
First received: February 11, 2011
Last updated: May 1, 2014
Last verified: May 2014
  Purpose

This study is designed to assess the effectiveness of a combination method of induction of labor using a urinary balloon catheter and prostaglandin gel.

The vaginal delivery rate for medical induction of labor is lower than the vaginal delivery rate for spontaneous labor. As a consequence, the frequency of cesarean section for failed induction in the United States is rising. This has led to a renewed effort to examine the effectiveness of the varied methods of induction.

The study is a randomized, unblinded trial of urinary balloon catheter and prostaglandin gel for induction of labor in term pregnant patients. Pregnant women presenting to the Palmetto Health Richland for a scheduled induction of labor will be offered enrollment in the trial. Patients who enroll in the study will be randomized into one of 3 study arms: urinary balloon catheter only, prostaglandin gel only and combination urinary balloon catheter and prostaglandin gel. Randomization will be per sealed envelope from the locked nurse medication storage area (Pyxis) located in Labor and Delivery at Palmetto Health Richland. The investigator will be given the next sequentially numbered study randomization envelope by the patient's nurse. The randomization assignment will be unblinded to the patient and her physicians. If the patient is not in active labor 6 hours after initiation of the intervention, a standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.


Condition Intervention
Failed Labour
Drug: Prepidil Gel
Device: Urinary Balloon Catheter
Other: Combined Urinary Catheter & Prepidil Gel

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Pre-Induction Cervical Ripening Using Prepidil Gel Administered Through a Urinary Balloon Catheter.

Resource links provided by NLM:


Further study details as provided by University of South Carolina:

Primary Outcome Measures:
  • Vaginal Delivery [ Time Frame: Gestational age 26-42 weeks ] [ Designated as safety issue: No ]
    The primary outcome of this study is vaginal delivery of a liveborn singleton pregnancy. The outcome is considered a vaginal delivery if accomplished by spontaneous vaginal delivery, operative forceps or vacuum forceps. The alternate outcome is delivery by cesarean section.


Enrollment: 102
Study Start Date: July 2010
Study Completion Date: May 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Urinary Balloon Catheter Only
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. The catheter will be deflated and removed after 6 hours. If spontaneously expelled from the uterus, time of expulsion will be noted. Six hours after insertion of catheter, a digital exam will be performed and Bishop score recorded. If no active labor at time of catheter removal or expulsion, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Device: Urinary Balloon Catheter
Pre-induction cervical ripening using a urinary balloon catheter device.
Other Name: Foley Catheter
Active Comparator: Prepadil Only
Prepidil Only : Prepidil gel will be inserted into the vaginal fornix according to manufacturer's direction. No oxytocin or other intervention will commence until 6 hours after insertion of gel. Six hours after insertion of gel, digital exam will be performed and Bishop score recorded. If no active labor 6 hours after the administration of gel, standardized protocol of oxytocin will commence. Labor management will be at the discretion of the physician.
Drug: Prepidil Gel
Pre-induction cervical ripening using dinoprostone gel in the vagina.
Other Name: Prepidil gel
Experimental: Combined Urinary Catheter & Prepidil Gel
A urinary balloon catheter will be placed through the cervix into the lower uterine segment and the bulb inflated with 40ml of saline. The catheter will be taped to the patient's thigh and placed under traction using a liter bag of saline. Prepidil gel will be inserted through the catheter into the lower uterine segment, in a dose equivalent to manufacturer's recommendation. No oxytocin or other intervention will commence until 6 hours after insertion of the catheter and administration of prepidil gel (even if catheter is spontaneously expelled). After 6 hours, digital exam will be performed and Bishop score recorded. If no active labor, standardized protocol of oxytocin will commence.
Other: Combined Urinary Catheter & Prepidil Gel
Pre-induction cervical ripening using dinoprostone gel injected through a urinary balloon catheter placed in the lower uterine segment.
Other Names:
  • Foley catheter
  • Prepidil Gel

  Show Detailed Description

  Eligibility

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

Inclusion Criteria:

  1. Single, live fetus
  2. Cephalic (head-first) presentation
  3. Reassuring fetal health assessment
  4. Gestational age between 26 and 42 weeks
  5. Maternal age 18 and above
  6. Bishop score less than 5

Exclusion Criteria:

  1. Multiple Gestation (twins, triplets, quadruplets)
  2. Fetal demise
  3. Fetal malpresentation
  4. Estimated fetal weight less than 500 grams or more than 4000 grams
  5. Placenta previa
  6. Non-reassuring fetal health assessment
  7. Maternal asthma
  8. Latex allergy
  9. Spontaneous labor
  10. Other contraindication to vaginal delivery
  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: NCT01390233

Locations
United States, South Carolina
Palmetto Health Richland Hospital
Columbia, South Carolina, United States, 29203
Sponsors and Collaborators
University of South Carolina
Investigators
Principal Investigator: Paul C Browne, MD University of South Carolina
  More Information

Publications:

Responsible Party: University of South Carolina
ClinicalTrials.gov Identifier: NCT01390233     History of Changes
Other Study ID Numbers: 2010-60
Study First Received: February 11, 2011
Results First Received: May 1, 2014
Last Updated: May 1, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Carolina:
Labor, obstetric
Labor, induced

Additional relevant MeSH terms:
Dinoprostone
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on August 28, 2014