TerminatedPhase 2/3

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

Stopped: difficult recruitment

United States6 participantsStarted 2014-07

Plain-language 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.

Who can participate

Age range18 Years – 35 Years

SexFEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Female * Between 18-35 years of age * 37 weeks gestation * Breech presentation Exclusion Criteria: * 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

What they're measuring

Successful Version of the Fetus Into the Vertex Position

Timeframe: average of 1 hour

Trial details

NCT IDNCT02115256

SponsorYaakov Beilin

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-04

Results submitted2017-03-31

View on ClinicalTrials.gov More External Cephalic Version trials