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

NCT ID: NCT01991743

Last Updated: 2020-01-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2017-01-31

Brief 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.

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."

Conditions

Pregnancy; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Drug:Group 2.5

Administration of 2.5 mg bupivacaine

Group Type: ACTIVE_COMPARATOR

Group 2.5

Intervention Type: DRUG

Administration of bupivacaine 2.5 mg.

Group 5

Administration of 5 mg bupivacaine.

Group Type: ACTIVE_COMPARATOR

Group 5

Intervention Type: DRUG

Administration of 5 mg bupivacaine

Group 7.5

Administration of 7.5mg bupivacaine.

Group Type: ACTIVE_COMPARATOR

Group 7.5

Intervention Type: DRUG

Administration of 7.5 mg bupivacaine

Group 10

Administration of 10 mg bupivacaine.

Group Type: ACTIVE_COMPARATOR

Group 10

Intervention Type: DRUG

Administration of 10mg bupivacaine.

Interventions

Group 2.5

Administration of bupivacaine 2.5 mg.

Intervention Type: DRUG

Group 5

Administration of 5 mg bupivacaine

Intervention Type: DRUG

Group 7.5

Administration of 7.5 mg bupivacaine

Intervention Type: DRUG

Group 10

Administration of 10mg bupivacaine.

Intervention Type: DRUG

Other Intervention Names

2.5 mg bupivacaine; 5 mg bupivacaine; Administration of 7.5 mg bupivacaine.; Administration of 10mg bupivacaine.

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

David Walega

Vice Chair Research Department of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

David Walega, MD

Role: STUDY_DIRECTOR

Northwestern University

Locations

Prentice Women's Hospital

Chicago, Illinois, United States

Countries

United States

References

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. No abstract available.

Reference Type: BACKGROUND

PMID: 9359456 (View on PubMed)

Hofmeyr GJ. Interventions to help external cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2002;(2):CD000184. doi: 10.1002/14651858.CD000184.

Reference Type: BACKGROUND

PMID: 12076384 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 3288930 (View on PubMed)

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

Reference Type: BACKGROUND

PMID: 8336883 (View on PubMed)

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. doi: 10.1213/00000539-199409000-00021.

Reference Type: BACKGROUND

PMID: 8067558 (View on PubMed)

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. doi: 10.1097/00000539-200108000-00035.

Reference Type: BACKGROUND

PMID: 11473871 (View on PubMed)

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. doi: 10.1016/s0029-7844(98)00456-6.

Reference Type: BACKGROUND

PMID: 10074976 (View on PubMed)

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. doi: 10.1016/s0002-9378(97)70029-2.

Reference Type: BACKGROUND

PMID: 9396908 (View on PubMed)

Mancuso KM, Yancey MK, Murphy JA, Markenson GR. Epidural analgesia for cephalic version: a randomized trial. Obstet Gynecol. 2000 May;95(5):648-51. doi: 10.1016/s0029-7844(99)00611-0.

Reference Type: BACKGROUND

PMID: 10775722 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 20127530 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 19682886 (View on PubMed)

Other Identifiers

STU00050371

Identifier Type: -

Identifier Source: org_study_id