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

NCT01991743 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2020-01-06

Study results available
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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

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.

Sponsors & Collaborators

Principal Investigators

  • David Walega, MD · Northwestern University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2016-10-31
Completion
2017-01-31

Countries

  • United States

Study Locations

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Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01991743 on ClinicalTrials.gov