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

Stopped early · Phase 2/Phase 3

Conditions studied: External Cephalic Version

In brief

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.

Key facts

Study ID

NCT02115256

Run by

Yaakov Beilin

People needed

6

Starts

2014-07-01

Expected to finish

2015-04-01

Last updated by the study team

2017-06-14

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Female
• Between 18-35 years of age
• 37 weeks gestation
• Breech presentation

You may not qualify if…

• Patients with ruptured membranes
• Multiple gestation
• Maternal age (age > 35)
• With known medical comorbidities (including hypertension (HTN), arrhythmias, endocrinologic diseases such as diabetes and thyroid disease, scoliosis, asthma)
• Allergies to nitroglycerine or terbutaline
• Prior abdominal or uterine surgery

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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