Ripening Interventions: Prostaglandins vs EASI Catheter
NCT ID: NCT00383942
Last Updated: 2017-03-13
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE4
80 participants
INTERVENTIONAL
2006-08-31
2008-06-18
Brief Summary
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Detailed Description
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Several studies have investigated the optimum cervical ripening agent, and review of current literature supports that misoprostol given in a dose of 25 micrograms every 4 hours intravaginally as the most efficacious and inexpensive regimen while maintaining safe maternal and fetal outcomes. Several studies have shown that misoprostol has a significantly shorter time to delivery compared with other methods of ripening. In fact, in a 2003 Cochrane Database Systematic Review, misoprostol was shown to have increased cervical ripening effectiveness and reduced failure to achieve vaginal delivery in 12-24 hours. Further, while uterine hyper-stimulation and tachysystole were more common in the misoprostol groups, no adverse neonatal outcomes were described. However, misoprostol has been shown to have a higher incidence of cesarean section for fetal intolerance to labor compared to other cervical ripening methods including EASI. Several studies support the ideal route of administration and dosage of misoprostol to be 25 micrograms every 4 hours intravaginally. This regimen leads to effective cervical ripening while reducing the dose-dependent effect of misoprostol on uterine tachysystole and hyperstimulation. Another aspect to consider in cervical ripening method is cost. Misoprostol is much less expensive than other methods including dinoprostone. In fact, one article reports that the average cost per patient for misoprostol treatment was $85 compared to $606 for dinoprostone insert.
Extra-amniotic saline infusion (EASI) has been introduced as a mechanical, non-pharmacological cervical ripening method. It involves placement of a Foley catheter through the cervix and is supplemented with continuous extra-amniotic infusion of saline. This is thought to improve prostaglandin release, resulting in shortened duration of labor. Several studies have been performed to determine the safety and efficacy of the EASI method.
Since misoprostol is efficacious, safe, and inexpensive, it is a superior method for cervical ripening and will act as a control for an experimental group undergoing cervical ripening with the EASI catheter. Our hypothesis is that cervical ripening with the EASI method will result in fewer cesarean sections for fetal intolerance to labor as compared to misoprostol. Furthermore, patients undergoing cervical ripening with EASI will experience a shorter time to delivery, have less expense, have fewer adverse effects, and will be more satisfied with EASI catheter than with misoprostol.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Misoprostol
Patients randomized to this arm will receive 25 micrograms of misoprostol every four hours.
Misoprostol
Misoprostol,25 micrograms every 4 hours.
EASI Catheter
Patients randomized to this arm will receive extra amniotic saline infusion (EASI) administered via catheter
Catheter
A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen
Interventions
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Misoprostol
Misoprostol,25 micrograms every 4 hours.
Catheter
A catheter with extra amniotic saline infusion (EASI) is placed in the uterus and applies pressure to the cervix to cause it to ripen
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Cephalic presentation
* 36 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
Exclusion Criteria
* Evidence of spontaneous labor (3 contractions in 10 minutes)
* Contraindication to induction of labor or to use of prostaglandins
* Fetal station higher than -3
18 Years
FEMALE
No
Sponsors
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Loyola University
OTHER
Responsible Party
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Scott Graziano
Associate Professor
Principal Investigators
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Scott Graziano, MD
Role: PRINCIPAL_INVESTIGATOR
Loyola University
Locations
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Loyola University Medical Center
Maywood, Illinois, United States
Countries
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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109040
Identifier Type: -
Identifier Source: org_study_id
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