Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: External Cephalic Version
Intervention: Intravenous Terbutaline (Drug); Intravenous Nitroglycerine (Drug)
Phase: Phase 2/Phase 3
Status: Terminated
Sponsored by: Yaakov Beilin Official(s) and/or principal investigator(s): Yaakov Beilin, MD, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
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.
Clinical Details
Official title: Intravenous Terbutaline Versus Intravenous Nitroglycerine for External Cephalic Version: A Double-Blinded Randomized Controlled Trial in Nulliparous Women
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Successful version of the fetus into the vertex position
Secondary outcome: Hypotensionneed for cesarean delivery tachycardia
Detailed description:
Breech presentation occurs in approximately 3-4% of all births and all women with breech
presentation at term undergo cesarean delivery. The only way to avoid a cesarean is to
manually turn the baby prior to the date of delivery, a procedure known as elective external
cephalic version (ECV). ECV has been shown to reduce the frequency of breech presentation
at term and thus lessen the risks associated with breech delivery and those of cesarean
section, with little risk to the mother or baby. Tocolysis, administered immediately prior
to the ECV and commonly used at The Mount Sinai Hospital, has been shown to improve the
success rate of ECV. Several different agents are known to cause tocolysis. These include
beta-mimetics (ritodrine, terbutaline), nitroglycerine (NTGL) and nifedipine. Terbutaline has
been shown to improve success rate of ECV. Another study published in 2004 by El-Sayed et
al showed that subcutaneous terbutaline was associated with higher rates of successful ECV
than IV NTGL in term patients. There is inconsistent data in regard to the success rate of
ECV with NTGL. In a study published in 2003 by Bujold et al, NTGL was associated with a
higher rate of side effects and a lower rate of successful ECV when compared to ritodrine.
Another study published in 2009 by Hilton et al showed that NTGL was more efficacious for
ECV in nulliparous versus multiparous women. Yet another study published in 2009 by Yanny
et al showed no differences between sublingual NTGL versus placebo in efficacy, and reported
no significant side effects. A study published in 2003 by Bujold et al showed that
sublingual NTGL was associated with a higher incidence of headache and did not improve the
success rate of ECV. It may be beneficial to use NTGL instead of terbutaline because NTGL
is a shorter acting agent and the procedure itself only lasts 10-15 minutes. Additionally,
both medications have side effects. Terbutaline is associated with maternal tachycardia,
hyperglycemia, hypokalemia, pulmonary edema, cardiac arrhythmias, hypertension and
myocardial ischemia, and NTGL is associated with maternal nausea, vomiting, headache, and
hypotension. For both medications the side effects are self- limiting but depending on the
patient's co-morbidities one drug may be beneficial for that individual patient.
To date no study has compared the efficacy of intravenous terbutaline versus intravenous
NTGL in women presenting for ECV. The purpose of this study is to determine if the success
rate of ECV can be improved with the use of IV NTGL.
Eligibility
Minimum age: 18 Years.
Maximum age: 35 Years.
Gender(s): Female.
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
Locations and Contacts
Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States
Additional Information
Starting date: July 2014
Last updated: April 13, 2015
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