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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01991743
• Other study ID #: STU00050371
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: January 2017

Study information

• Verified date: December 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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."

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: January 2017
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain
• Pregnancy

Intervention

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

Locations

Country	Name	City	State
United States	Prentice Women's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (11)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Success Rate of External Cephalic Version	Rates of successful version evaluated among the 4 dose groups.	Completion of the procedure
Secondary	Mode of Delivery		To time of delivery
Secondary	Indication of Cesarean Delivery		To time of delivery
Secondary	Pain Score During the Procedure	pain score during the procedure (Visual Analog Score: VAS=0 no pain -100 worst pain imaginable, scale)	< 20 minutes
Secondary	Abdominal Relaxation	Obstetrician rating of participants abdominal relaxation (Visual analog score: VAS score= 0 no relaxation- complete relaxation 100)	<20 minutes