CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 240 enrolled
Drug / intervention
Group 2.5 +3 moredrug
Likely dose
Group 2.5 2.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01991743
NCT01991743N/ACompleted

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

Northwestern University·interventional·Posted Nov 25, 2013·Updated Jan 6, 2020

In Brief

A clinical study evaluating Group 2.5, Group 5, and 2 other interventions for Pregnancy and Pain. Completed, enrolled 240 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPregnancy, Pain
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2013
Enrollment StartMay 1, 2011
Primary CompletionOct 1, 2016
Study CompletionJan 1, 2017
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 12.6 years ago

Interventions

Group 2.5drug

Administration of bupivacaine 2.5 mg.

Group 5drug

Administration of 5 mg bupivacaine

Group 7.5drug

Administration of 7.5 mg bupivacaine

Group 10drug

Administration of 10mg bupivacaine.