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Success of External Cephalic Version Study

NCT03106753 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2020-10-09

Study results available
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Summary

The purpose of this study is to determine the best way to optimize the success of external cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is recommended because it may decrease the risk of needing a cesarean section for abnormal presentation. While the study team knows that this procedure can be effective, the study team still has some un-answered questions as to the best way to perform this procedure to increase the chance of success. Many prior studies have shown that using spinal anesthesia (a shot of medication placed in your back to numb and relax the abdomen) can increase the success rate of a version. This ultimately has led to the finding that using this anesthesia can decrease the rate of cesarean section. However, there have been only a small number of studies assessing the success rate if spinal anesthesia is used only in the event that without it fails. Therefore the study team is going to compare patients who receive spinal anesthesia with those who only receive spinal anesthesia if the procedure to turn the baby (ECV) fails without it.

Conditions

  • External Cephalic Version

Interventions

DRUG

Bupivacaine

intrathecal bupivacaine 7.5 mg

DRUG

Terbutaline

0.25 mg Terbutaline subcutaneously

Sponsors & Collaborators

Principal Investigators

  • Natalie Porat, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-04-12
Primary Completion
2018-05-05
Completion
2018-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

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 NCT03106753 on ClinicalTrials.gov