A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version

Overview

We plan to conduct a prospective, single blinded, randomized clinical trial to assess the impact of combined spinal-epidural dosing on the success rate of, and patient satisfaction during, external version for breech fetal position and the incidence of vaginal vs. Cesarean delivery.

The research aim of this project is to determine the ideal neuraxial dosing strategy to maximize success of external cephalic version (ECV).

The research questions, does a combined spinal-epidural (CSE) of a higher dose result in greater success in converting a breech presentation to vertex during external cephalic version (ECV).

The hypotheses of this project is that CSE at higher dose will result in greater ECV success than analgesic dosing.

The research significance:Increasing the success and comfort of ECV for fetal malpresentation may help decrease the cesarean section rate.

Full Title of Study: “A Randomized Controlled Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Care Provider)
  • Study Primary Completion Date: October 2016

Detailed Description

At term 2 to 3% of singleton pregnancies are in breech presentation. Many of these deliveries are managed by cesarean delivery due to higher neonatal morbidity associated with vaginal breech delivery. However, cesarean delivery, the safer option for the baby, is associated with a higher incidence of maternal complications for both the current and subsequent pregnancies. External cephalic version (ECV) is a procedure commonly used to attempt to manually rotate the fetus into vertex position. This facilitates vaginal delivery and thus avoids higher maternal and/or neonatal complications. (Hofmeyr Cochrane Review) Obstetricians generally perform versions after 36 weeks gestational age with a reportable success rate of 50-80%, depending on several factors, including patient characteristics. (Fortunato, Zhang, ACOG 1997 ECV) The most common technique involves external manipulation of the fetal position preceded by pharmacologic uterine relaxation. Until recently, pain relief was generally provided in the form of intravenous opioids such as fentanyl. A more efficacious form of analgesia is the use of neuraxial opioids and local anesthetics (neuraxial analgesia), a technique commonly used for labor and delivery analgesia.

Two non-randomized studies of neuraxial analgesia compared to systemic analgesia found improved success of external cephalic version in the neuraxial analgesia groups.(Carlan, Birnbach) Three randomized trials have conflicting results: 2 demonstrate an increase in success, one shows no difference. (Dugoff, Schorr, Mancuso) None of these studies have blinded the obstetrician performing the version. In 2010, Lavoie and colleagues completed a meta-analysis looking at ECV performed under analgesic and anesthetic neuraxial doses. The analgesic dose included spinal bupivacaine and epidural dosing. The anesthestic groups gave higher doses of spinal or epidural bupivacaine. This meta-analysis suggested that those patients who had received an anesthetic dose of had more successful ECV. All published studies examining pain outcomes have demonstrated that neuraxial analgesia results in greater patient comfort during this procedure.

The American College of Obstetricians and Gynecologists (ACOG) has stated, "Currently there is not enough evidence to make a recommendation favoring or opposing anesthesia during ECV (external cephalic version) attempts."

Interventions

  • Drug: Group 2.5
    • Administration of bupivacaine 2.5 mg.
  • Drug: Group 5
    • Administration of 5 mg bupivacaine
  • Drug: Group 7.5
    • Administration of 7.5 mg bupivacaine
  • Drug: Group 10
    • Administration of 10mg bupivacaine.

Arms, Groups and Cohorts

  • Active Comparator: Drug:Group 2.5
    • Administration of 2.5 mg bupivacaine
  • Active Comparator: Group 5
    • Administration of 5 mg bupivacaine.
  • Active Comparator: Group 7.5
    • Administration of 7.5mg bupivacaine.
  • Active Comparator: Group 10
    • Administration of 10 mg bupivacaine.

Clinical Trial Outcome Measures

Primary Measures

  • Success Rate of External Cephalic Version
    • Time Frame: Completion of the procedure
    • Rates of successful version evaluated among the 4 dose groups.

Secondary Measures

  • Mode of Delivery
    • Time Frame: To time of delivery
  • Indication of Cesarean Delivery
    • Time Frame: To time of delivery
  • Pain Score During the Procedure
    • Time Frame: < 20 minutes
    • pain score during the procedure (Visual Analog Score: VAS=0 no pain -100 worst pain imaginable, scale)
  • Abdominal Relaxation
    • Time Frame: <20 minutes
    • Obstetrician rating of participants abdominal relaxation (Visual analog score: VAS score= 0 no relaxation- complete relaxation 100)

Participating in This Clinical Trial

Inclusion Criteria

  • Healthy patients age 18 and older
  • Breech presentation
  • Singleton gestation .scheduled for ECV desiring CSE.

Exclusion Criteria

  • Refusal
  • Contraindication to neuraxial (coagulopathy, anticoagulant use, local infection, sepsis etc) .Rupture of membranes.
  • Drop-out: Patients may choose to drop-out of the study at any time. The physicians involved in this study may choose to end a patient's involvement in the study at their discretion.

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Provider of Information About this Clinical Study
    • Principal Investigator: David Walega, Vice Chair Research Department of Anesthesiology – Northwestern University
  • Overall Official(s)
    • David Walega, MD, Study Director, Northwestern University

References

Hofmeyr GJ. Interventions to help external cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2002;(2):CD000184. Review. Update in: Cochrane Database Syst Rev. 2004;(1):CD000184.

Fortunato SJ, Mercer LJ, Guzick DS. External cephalic version with tocolysis: factors associated with success. Obstet Gynecol. 1988 Jul;72(1):59-62.

Zhang J, Bowes WA Jr, Fortney JA. Efficacy of external cephalic version: a review. Obstet Gynecol. 1993 Aug;82(2):306-12. Review.

ACOG practice patterns. External cephalic version. Number 4, July 1997. American College of Obstetricians and Gynecologists. Int J Gynaecol Obstet. 1997 Oct;59(1):73-80.

Carlan SJ, Dent JM, Huckaby T, Whittington EC, Shaefer D. The effect of epidural anesthesia on safety and success of external cephalic version at term. Anesth Analg. 1994 Sep;79(3):525-8.

Birnbach DJ, Matut J, Stein DJ, Campagnuolo J, Drimbarean C, Grunebaum A, Kuroda MM, Thys DM. The effect of intrathecal analgesia on the success of external cephalic version. Anesth Analg. 2001 Aug;93(2):410-3, 4th contents page.

Dugoff L, Stamm CA, Jones OW 3rd, Mohling SI, Hawkins JL. The effect of spinal anesthesia on the success rate of external cephalic version: a randomized trial. Obstet Gynecol. 1999 Mar;93(3):345-9.

Schorr SJ, Speights SE, Ross EL, Bofill JA, Rust OA, Norman PF, Morrison JC. A randomized trial of epidural anesthesia to improve external cephalic version success. Am J Obstet Gynecol. 1997 Nov;177(5):1133-7.

Mancuso KM, Yancey MK, Murphy JA, Markenson GR. Epidural analgesia for cephalic version: a randomized trial. Obstet Gynecol. 2000 May;95(5):648-51.

Lavoie A, Guay J. Anesthetic dose neuraxial blockade increases the success rate of external fetal version: a meta-analysis. Can J Anaesth. 2010 May;57(5):408-14. doi: 10.1007/s12630-010-9278-4. Epub 2010 Feb 3.

Sullivan JT, Grobman WA, Bauchat JR, Scavone BM, Grouper S, McCarthy RJ, Wong CA. A randomized controlled trial of the effect of combined spinal-epidural analgesia on the success of external cephalic version for breech presentation. Int J Obstet Anesth. 2009 Oct;18(4):328-34. doi: 10.1016/j.ijoa.2009.02.006. Epub 2009 Aug 13.

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