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Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline

NCT02115256 · Status: TERMINATED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2017-06-14

Study results available
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Summary

Breech presentation of a term pregnancy is a common occurrence. A procedure known as external cephalic version (ECV) is frequently used by obstetricians to turn the baby into the vertex position prior to delivery in order to avoid a cesarean section and the associated risks. Medications to relax the uterus, known as tocolytics, are used in conjunction with the procedure as they have been shown to improve the success rate of ECV, but with inconsistent, varying results.

Conditions

  • External Cephalic Version

Interventions

DRUG

Intravenous Terbutaline

0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.

DRUG

Intravenous Nitroglycerine

The dose of IV nitroglycerine will be 100 micrograms three minutes before beginning the procedure, and because of it's short half-life (approximately 3 minutes) will be followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.

Sponsors & Collaborators

  • Yaakov Beilin

    lead OTHER

Principal Investigators

  • Yaakov Beilin, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • United States

Study Locations

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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 NCT02115256 on ClinicalTrials.gov