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

NCT01991743 | Completed Results

• 1 other identifier: STU00050371
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy; Pain

Keywords

Version; Pregnancy; Vaginal Delivery; Pain Control; Combined Spinal Epidural

Outcome Measures

Primary Outcomes (1)

• Success Rate of External Cephalic Version

  Rates of successful version evaluated among the 4 dose groups.

  Completion of the procedure

Secondary Outcomes (4)

• Mode of Delivery

  To time of delivery

• Indication of Cesarean Delivery

  To time of delivery

• Pain Score During the Procedure

  < 20 minutes

• Abdominal Relaxation

  <20 minutes

Study Arms (4)

Drug:Group 2.5

ACTIVE COMPARATOR

Administration of 2.5 mg bupivacaine

Drug: Group 2.5

Group 5

ACTIVE COMPARATOR

Administration of 5 mg bupivacaine.

Drug: Group 5

Group 7.5

ACTIVE COMPARATOR

Administration of 7.5mg bupivacaine.

Drug: Group 7.5

Group 10

ACTIVE COMPARATOR

Administration of 10 mg bupivacaine.

Drug: Group 10

Interventions

Group 2.5 DRUG

Administration of bupivacaine 2.5 mg.

Also known as: 2.5 mg bupivacaine

Drug:Group 2.5

Group 5 DRUG

Administration of 5 mg bupivacaine

Also known as: 5 mg bupivacaine

Group 5

Group 7.5 DRUG

Administration of 7.5 mg bupivacaine

Also known as: Administration of 7.5 mg bupivacaine.

Group 7.5

Group 10 DRUG

Administration of 10mg bupivacaine.

Also known as: Administration of 10mg bupivacaine.

Group 10

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Prentice Women's Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (11)

• 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.

  PMID: 12076384 BACKGROUND

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

  PMID: 3288930 BACKGROUND

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

  PMID: 8336883 BACKGROUND

• 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.

  PMID: 9359456 BACKGROUND

• 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.

  PMID: 8067558 BACKGROUND

• 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.

  PMID: 11473871 BACKGROUND

• 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.

  PMID: 10074976 BACKGROUND

• 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.

  PMID: 9396908 BACKGROUND

• 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.

  PMID: 10775722 BACKGROUND

• 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.

  PMID: 20127530 BACKGROUND

• 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.

  PMID: 19682886 BACKGROUND

MeSH Terms

Conditions

Pain; Agnosia

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Limitations and Caveats

The limitations include group allocation concealment and lack of a control group. The obstetrician's assessment of success, pain, anxiety, and fetus status may have prejudiced the decision to proceed or persist with external cephalic version.

Results Point of Contact

• Title: Dr. Robert J McCarthy
• Organization: Northwestern University

r-mccarthy@northwestern.edu

312-695-4976

Study Officials

• David Walega, MD

  Northwestern University

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Vice Chair Research Department of Anesthesiology

Study Record Dates

• First Submitted: October 29, 2013
• First Posted: November 25, 2013
• Study Start: May 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 6, 2020
• Results First Posted: January 6, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)