Comparison of Pre-Induction Cervical Ripening - Full Text View

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: Dinoprostone Gel Device: Urinary Balloon Catheter Other: Urinary Balloon Catheter Device and Dinoprostone 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:

MedlinePlus related topics: Childbirth

Drug Information available for: Dinoprostone

U.S. FDA Resources

Further study details as provided by University of South Carolina:

Primary Outcome Measures:

Route of 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 cesaeran section.

Secondary Outcome Measures:

Time from initiation of induction to delivery [ Time Frame: Time from induction to delivery (up to 72 hours) ] [ Designated as safety issue: No ]
One of several secondary outcomes to be studied is time from initiation of induction to delivery.
Newborn Outcome [ Time Frame: 30 days after delivery ] [ Designated as safety issue: No ]
One of several secondary outcomes to be studied is infant outcome, including birth weight, Apgar score, admission to Special Care/NICU, and others.
Maternal complications. [ Time Frame: 42 days after delivery ] [ Designated as safety issue: No ]
One of several secondary outcomes to be studied is maternal complications, including infection, excessive bleeding, need for transfusion and unexpected hospital re-admission.

Estimated Enrollment:	90
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 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: Dinoprostone Gel Pre-induction cervical ripening using dinoprostone gel in the vagina. Other Name: Prepidil gel
Experimental: Combined Urinary Catheter & Prepadil 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: Urinary Balloon Catheter Device and Dinoprostone 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:

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

Exclusion Criteria:

Multiple Gestation (twins, triplets, quadruplets)
Fetal demise
Fetal malpresentation
Estimated fetal weight less than 500 grams or more than 4000 grams
Placenta previa
Non-reassuring fetal health assessment
Maternal asthma
Latex allergy
Spontaneous labor
Other contraindication to vaginal delivery

Contacts and Locations

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:

Menacker F, Hamilton BE. Recent trends in cesarean delivery in the United States. NCHS Data Brief. 2010 Mar;(35):1-8.

Greybush M, Singleton C, Atlas RO, Balducci J, Rust OA. Preinduction cervical ripening techniques compared. J Reprod Med. 2001 Jan;46(1):11-7.

Matonhodze BB, Hofmeyr GJ, Levin J. Labour induction at term--a randomised trial comparing Foley catheter plus titrated oral misoprostol solution, titrated oral misoprostol solution alone, and dinoprostone. S Afr Med J. 2003 May;93(5):375-9.

Kelly AJ, Malik S, Smith L, Kavanagh J, Thomas J. Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term. Cochrane Database Syst Rev. 2009 Oct 7;(4):CD003101. Review.

ACOG Committee on Practice Bulletins -- Obstetrics. ACOG Practice Bulletin No. 107: Induction of labor. Obstet Gynecol. 2009 Aug;114(2 Pt 1):386-97. Review. No abstract available.

Heinemann J, Gillen G, Sanchez-Ramos L, Kaunitz AM. Do mechanical methods of cervical ripening increase infectious morbidity? A systematic review. Am J Obstet Gynecol. 2008 Aug;199(2):177-87; discussion 187-8. Review.

James C, Peedicayil A, Seshadri L. Use of the Foley catheter as a cervical ripening agent prior to induction of labor. Int J Gynaecol Obstet. 1994 Dec;47(3):229-32.

Cromi A, Ghezzi F, Tomera S, Uccella S, Lischetti B, Bolis PF. Cervical ripening with the Foley catheter. Int J Gynaecol Obstet. 2007 May;97(2):105-9. Epub 2007 Feb 20.

Saunders JR. Foley-catheter induction of labour. Br Med J. 1972 Oct 28;4(5834):237. No abstract available.

Hemlin J, Möller B. Extraamniotic saline infusion is promising in preparing the cervix for induction of labor. Acta Obstet Gynecol Scand. 1998 Jan;77(1):45-9.

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.

Wagman H, Usherwood M. Intrauterine death treated with intrauterine extra-amniotic prostaglandin E2. Br J Clin Pract. 1974 Sep;28(9):318.

Luengo J, Keirse MJ, Bennebroek Gravenhorst J. Extraamniotic prostaglandin F2 alpha for intrauterine death and fetal abnormality. Eur J Obstet Gynecol Reprod Biol. 1977;7(5):325-9.

Fuchs AR, Goeschen K, Rasmussen AB, Rehnström JV. Cervical ripening and plasma prostaglandin levels. Comparison of endocervical and extra-amniotic PGE2. Prostaglandins. 1984 Aug;28(2):217-27.

Liu HS, Chang YK, Chu TY, Yu MH, Chen WH. Extra-amniotic balloon with PGE2 versus extra-ovular Foley catheter with PGF2alpha in mid-trimester pregnancy termination. Int J Gynaecol Obstet. 1998 Oct;63(1):51-4.

Sherman DJ, Frenkel E, Pansky M, Caspi E, Bukovsky I, Langer R. Balloon cervical ripening with extra-amniotic infusion of saline or prostaglandin E2: a double-blind, randomized controlled study. Obstet Gynecol. 2001 Mar;97(3):375-80.

American College of Obstetricians and Gynecologists Committee on Obstetric Practice. ACOG Committee Opinion No. 342: induction of labor for vaginal birth after cesarean delivery. Obstet Gynecol. 2006 Aug;108(2):465-8.

ACOG Committee Opinion. American College of Obstetrician and Gynecologist. ACOG Committee Opinion. Number 283, May 2003. New U.S. Food and Drug Administration labeling on Cytotec (misoprostol) use and pregnancy. Obstet Gynecol. 2003 May;101(5 Pt 1):1049-50.

Thomas IL, Chenoweth JN, Tronc GN, Johnson IR. Preparation for induction of labour of the unfavourable cervix with Foley catheter compared with vaginal prostaglandin. Aust N Z J Obstet Gynaecol. 1986 Feb;26(1):30-5.

St Onge RD, Connors GT. Preinduction cervical ripening: a comparison of intracervical prostaglandin E2 gel versus the Foley catheter. Am J Obstet Gynecol. 1995 Feb;172(2 Pt 1):687-90.

Orhue AA. Induction of labour at term in primigravidae with low Bishop's score: a comparison of three methods. Eur J Obstet Gynecol Reprod Biol. 1995 Feb;58(2):119-25.

Ghezzi F, Massimo F, Raio L, Di Naro E, Balestreri D, Bolis P. Extra-amniotic Foley catheter and prostaglandin E(2) gel for cervical ripening at term gestation. Eur J Obstet Gynecol Reprod Biol. 2001 Aug;97(2):183-7.

Sciscione AC, Nguyen L, Manley J, Pollock M, Maas B, Colmorgen G. A randomized comparison of transcervical Foley catheter to intravaginal misoprostol for preinduction cervical ripening. Obstet Gynecol. 2001 Apr;97(4):603-7.

Chung JH, Huang WH, Rumney PJ, Garite TJ, Nageotte MP. A prospective randomized controlled trial that compared misoprostol, Foley catheter, and combination misoprostol-Foley catheter for labor induction. Am J Obstet Gynecol. 2003 Oct;189(4):1031-5.

Niromanesh S, Mosavi-Jarrahi A, Samkhaniani F. Intracervical Foley catheter balloon vs. prostaglandin in preinduction cervical ripening. Int J Gynaecol Obstet. 2003 Apr;81(1):23-7.

Al-Taani MI. Comparison of prostaglandin E2 tablets or Foley catheter for labour induction in grand multiparas. East Mediterr Health J. 2004 Jul-Sep;10(4-5):547-53.

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.

Dalui R, Suri V, Ray P, Gupta I. Comparison of extraamniotic Foley catheter and intracervical prostaglandin E gel for preinduction cervical ripening. Acta Obstet Gynecol Scand. 2005 Apr;84(4):362-7.

Owolabi AT, Kuti O, Ogunlola IO. Randomised trial of intravaginal misoprostol and intracervical Foley catheter for cervical ripening and induction of labour. J Obstet Gynaecol. 2005 Aug;25(6):565-8.

Adeniji AO, Olayemi O, Odukogbe AA. Intravaginal misoprostol versus transcervical Foley catheter in pre-induction cervical ripening. Int J Gynaecol Obstet. 2006 Feb;92(2):130-2. Epub 2005 Dec 2. No abstract available.

Saleem S. Efficacy of dinoprostone, intracervical foleys and misoprostol in labor induction. J Coll Physicians Surg Pak. 2006 Apr;16(4):276-9.

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
Last Updated:	May 13, 2013
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 May 23, 2013