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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

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ClinicalTrials.gov Identifier: NCT02115256
Recruitment Status : Terminated (difficult recruitment)
First Posted : April 16, 2014
Results First Posted : June 14, 2017
Last Update Posted : June 14, 2017
Sponsor:
Information provided by (Responsible Party):
Yaakov Beilin, Icahn School of Medicine at Mount Sinai

Brief 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.

Condition or disease Intervention/treatment Phase
External Cephalic Version Drug: Intravenous Terbutaline Drug: Intravenous Nitroglycerine Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Intravenous Terbutaline Versus Intravenous Nitroglycerine for External Cephalic Version: A Double-Blinded Randomized Controlled Trial in Nulliparous Women
Study Start Date : July 2014
Actual Primary Completion Date : April 2015
Actual Study Completion Date : April 2015

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Intravenous Terbutaline
0.25 mL of Intravenous Terbutaline
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.
Other Names:
  • Terbutaline
  • Brethine
  • Bricanyl
  • Brethaire
  • Terbutalin
  • (RS)-5-[2-(tert-butylamino)-1-hydroxyethyl]benzene-1,3-diol)

Active Comparator: Intravenous Nitroglycerine
IV nitroglycerine 100 micrograms three minutes before beginning the procedure, then followed by a second dose 3 minutes later just after the start of the procedure for a total of 200 micrograms.
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.
Other Names:
  • Nitroglycerine
  • Nitroglycerin
  • Trinitroglycerin
  • Trinitroglycerine
  • nitro
  • 1,2,3-trinitroxypropane




Primary Outcome Measures :
  1. Successful Version of the Fetus Into the Vertex Position [ Time Frame: average of 1 hour ]
    Number of participants that had successful version of the fetus into the vertex position.


Secondary Outcome Measures :
  1. Hypotension [ Time Frame: average of 1 hour ]
    Number of participants with hypotension

  2. Need for Cesarean Delivery [ Time Frame: average of 1 hour ]
    Number of participants that needed a cesarean delivery

  3. Tachycardia [ Time Frame: average of 1 hour ]
    Number of participants that had tachycardia



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115256


Locations
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United States, New York
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Sponsors and Collaborators
Yaakov Beilin
Investigators
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Principal Investigator: Yaakov Beilin, MD Icahn School of Medicine at Mount Sinai
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Responsible Party: Yaakov Beilin, Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02115256    
Other Study ID Numbers: GCO 14-0636
First Posted: April 16, 2014    Key Record Dates
Results First Posted: June 14, 2017
Last Update Posted: June 14, 2017
Last Verified: May 2017
Keywords provided by Yaakov Beilin, Icahn School of Medicine at Mount Sinai:
External Cephalic Version
breech
Additional relevant MeSH terms:
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Nitroglycerin
Terbutaline
Vasodilator Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action