Ripening Interventions: Prostaglandins vs EASI Catheter

NCT00383942 | Terminated Phase 4 Results DMC FDA Drug FDA Device

• 1 other identifier: 109040
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this randomized clinical trial is to compare the effect of misoprostol vs extra amniotic saline infusion via a catheter (EASI) for cervical ripening on the proportion of patients delivered by cesarean section for fetal intolerance of labor versus vaginal delivery. The primary hypothesis is that patients undergoing cervical ripening with EASI catheter are less likely to undergo cesarean section for fetal intolerance of labor when compared to women who receive misoprostol.

Conditions

Cesarean Section

Keywords

Pregnancy; Extra amniotic saline infusion; Misoprostol; Labor induction

Outcome Measures

Primary Outcomes (1)

• Proportion of Women Undergoing Cesarean Section for Fetal Intolerance of Labor

  The number of women undergoing cesarean section will be compared between the misoprostol arm and EASI arm. The primary hypothesis is that the odds of receiving a cesarean section is lower among patients assigned to EASI when compared to patients who receive misoprostol.

  At time of delivery

Study Arms (2)

Misoprostol

ACTIVE COMPARATOR

Patients randomized to this arm will receive 25 micrograms of misoprostol every four hours.

Drug: Misoprostol

EASI Catheter

EXPERIMENTAL

Patients randomized to this arm will receive extra amniotic saline infusion (EASI) administered via catheter

Device: Catheter

Interventions

Misoprostol DRUG

Misoprostol,25 micrograms every 4 hours.

Also known as: Cytotec

Misoprostol

Catheter DEVICE

A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen

Also known as: EASI

EASI Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Singleton pregnancy
• Cephalic presentation
• completed weeks of gestation
• Intact membranes
• Unfavorable cervix (defined as Bishop score \< 5)
• Indication for induction of labor
• Fetal Station less than or equal to -3

You may not qualify if:

• Clinically significant vaginal bleeding
• Evidence of spontaneous labor (3 contractions in 10 minutes)
• Contraindication to induction of labor or to use of prostaglandins
• Fetal station higher than -3

Sponsors & Collaborators

• Loyola University: lead

Study Sites (1)

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Related Publications (15)

• 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. doi: 10.1067/mob.2003.458.

  PMID: 12824994 BACKGROUND

• 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. doi: 10.1016/j.ijgo.2005.02.010. Epub 2005 Apr 2.

  PMID: 15919393 BACKGROUND

• 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. doi: 10.1097/01.AOG.0000198629.44186.c8.

  PMID: 16449106 BACKGROUND

• Sanchez-Ramos L, Peterson DE, Delke I, Gaudier FL, Kaunitz AM. Labor induction with prostaglandin E1 misoprostol compared with dinoprostone vaginal insert: a randomized trial. Obstet Gynecol. 1998 Mar;91(3):401-5. doi: 10.1016/s0029-7844(97)00673-x.

  PMID: 9491868 BACKGROUND

• Garry D, Figueroa R, Kalish RB, Catalano CJ, Maulik D. Randomized controlled trial of vaginal misoprostol versus dinoprostone vaginal insert for labor induction. J Matern Fetal Neonatal Med. 2003 Apr;13(4):254-9. doi: 10.1080/jmf.13.4.254.259.

  PMID: 12854927 BACKGROUND

• Adeniji OA, Oladokun A, Olayemi O, Adeniji OI, Odukogbe AA, Ogunbode O, Aimakhu CO, Omigbodun AO, Ilesanmi AO. Pre-induction cervical ripening: transcervical foley catheter versus intravaginal misoprostol. J Obstet Gynaecol. 2005 Feb;25(2):134-9. doi: 10.1080/01443610500040737.

  PMID: 15814391 BACKGROUND

• Abramovici D, Goldwasser S, Mabie BC, Mercer BM, Goldwasser R, Sibai BM. A randomized comparison of oral misoprostol versus Foley catheter and oxytocin for induction of labor at term. Am J Obstet Gynecol. 1999 Nov;181(5 Pt 1):1108-12. doi: 10.1016/s0002-9378(99)70090-6.

  PMID: 10561627 BACKGROUND

• Hofmeyr GJ, Gulmezoglu AM, Pileggi C. Vaginal misoprostol for cervical ripening and induction of labour. Cochrane Database Syst Rev. 2010 Oct 6;2010(10):CD000941. doi: 10.1002/14651858.CD000941.pub2.

  PMID: 20927722 BACKGROUND

• le Roux PA, Olarogun JO, Penny J, Anthony J. Oral and vaginal misoprostol compared with dinoprostone for induction of labor: a randomized controlled trial. Obstet Gynecol. 2002 Feb;99(2):201-5. doi: 10.1016/s0029-7844(01)01681-7.

  PMID: 11814497 BACKGROUND

• Guinn DA, Goepfert AR, Christine M, Owen J, Hauth JC. Extra-amniotic saline, laminaria, or prostaglandin E(2) gel for labor induction with unfavorable cervix: a randomized controlled trial. Obstet Gynecol. 2000 Jul;96(1):106-12. doi: 10.1016/s0029-7844(00)00856-5.

  PMID: 10862852 BACKGROUND

• Sanchez-Ramos L, Kaunitz AM, Wears RL, Delke I, Gaudier FL. Misoprostol for cervical ripening and labor induction: a meta-analysis. Obstet Gynecol. 1997 Apr;89(4):633-42. doi: 10.1016/S0029-7844(96)00374-2.

  PMID: 9083326 BACKGROUND

• Meydanli MM, Caliskan E, Burak F, Narin MA, Atmaca R. Labor induction post-term with 25 micrograms vs. 50 micrograms of intravaginal misoprostol. Int J Gynaecol Obstet. 2003 Jun;81(3):249-55. doi: 10.1016/s0020-7292(03)00042-0.

  PMID: 12767565 BACKGROUND

• Has R, Batukan C, Ermis H, Cevher E, Araman A, Kilic G, Ibrahimoglu L. Comparison of 25 and 50 microg vaginally administered misoprostol for preinduction of cervical ripening and labor induction. Gynecol Obstet Invest. 2002;53(1):16-21. doi: 10.1159/000049405.

  PMID: 11803223 BACKGROUND

• Diro M, Adra A, Gilles JM, Nassar A, Rodriguez A, Salamat SM, Beydoun SN, O'Sullivan MJ, Yasin SY, Burkett G. A double-blind randomized trial of two dose regimens of misoprostol for cervical ripening and labor induction. J Matern Fetal Med. 1999 May-Jun;8(3):114-8. doi: 10.1002/(SICI)1520-6661(199905/06)8:33.0.CO;2-5.

  PMID: 10338065 BACKGROUND

• Sharami SH, Milani F, Zahiri Z, Mansour-Ghanaei F. A randomized trial of prostaglandin E2 gel and extra-amniotic saline infusion with high dose oxytocin for cervical ripening. Med Sci Monit. 2005 Aug;11(8):CR381-6. Epub 2005 Jul 25.

  PMID: 16049380 BACKGROUND

MeSH Terms

Interventions

Misoprostol; Catheters

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors; Equipment and Supplies

Limitations and Caveats

This trial was terminated prematurely due to a department policy change regarding inductions of labor.

Results Point of Contact

• Title: Scott Graziano, M.D.
• Organization: Loyola University

sgrazia@lumc.edu

708-216-6288

Study Officials

• Scott Graziano, MD

  Loyola University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 2, 2006
• First Posted: October 4, 2006
• Study Start: August 31, 2006
• Primary Completion: June 18, 2008
• Study Completion: June 18, 2008
• Last Updated: March 13, 2017
• Results First Posted: March 13, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)