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

• Status: Terminated
• Trial end date: 2015-04-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yaakov Beilin
• Treatments: Nitroglycerin; Terbutaline

Criteria

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