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

• Sponsor: Yaakov Beilin (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02115256
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arms: 2
• Duration (Months): 9
• Patients Per Site Per Month: 0.7

Study Details

Study Description

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.

Study Design

• Study Type: Interventional
• 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: Jul 1, 2014
• Actual Primary Completion Date: Apr 1, 2015
• Actual Study Completion Date: Apr 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Successful Version of the Fetus Into the Vertex Position [average of 1 hour]

   Number of participants that had successful version of the fetus into the vertex position.

Secondary Outcome Measures

1. Hypotension [average of 1 hour]

   Number of participants with hypotension

2. Need for Cesarean Delivery [average of 1 hour]

   Number of participants that needed a cesarean delivery

3. Tachycardia [average of 1 hour]

   Number of participants that had tachycardia

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 35 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Icahn School of Medicine at Mount Sinai	New York	New York	United States	10029

Sponsors and Collaborators

• Yaakov Beilin

Investigators

• Principal Investigator: Yaakov Beilin, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• 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: Apr 16, 2014
• Last Update Posted: Jun 14, 2017
• Last Verified: May 1, 2017

• Keywords provided by Yaakov Beilin, Professor, Icahn School of Medicine at Mount Sinai: External Cephalic Version; breech
• Additional relevant MeSH terms: Nitroglycerin; Terbutaline

Study Results

Participant Flow

Recruitment Details	6 Participants were enrolled from 06/12/2014 to 05/12/2015.

Arm/Group Title	Intravenous Terbutaline	Intravenous Nitroglycerine
Arm/Group Description	0.25 mL of Intravenous Terbutaline 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.	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. 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.
Period Title: Overall Study
STARTED	3	3
COMPLETED	3	2
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Intravenous Terbutaline	Intravenous Nitroglycerine	Total
Arm/Group Description	0.25 mL of Intravenous Terbutaline 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.	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. 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.	Total of all reporting groups
Overall Participants	3	2	5
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	32 (1)	36 (2)	34 (3)
Sex: Female, Male (Count of Participants)
Female	3 100%	2 100%	5 100%
Male	0 0%	0 0%	0 0%

Outcome Measures

1. Primary Outcome

Title	Successful Version of the Fetus Into the Vertex Position
Description	Number of participants that had successful version of the fetus into the vertex position.
Time Frame	average of 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Terbutaline	Intravenous Nitroglycerine
Arm/Group Description	0.25 mL of Intravenous Terbutaline 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.	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. 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.
Measure Participants	3	2
Count of Participants [Participants]	3 100%	0 0%

2. Secondary Outcome

Title	Hypotension
Description	Number of participants with hypotension
Time Frame	average of 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Terbutaline	Intravenous Nitroglycerine
Arm/Group Description	0.25 mL of Intravenous Terbutaline 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.	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. 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.
Measure Participants	3	2
Count of Participants [Participants]	2 66.7%	1 50%

3. Secondary Outcome

Title	Need for Cesarean Delivery
Description	Number of participants that needed a cesarean delivery
Time Frame	average of 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Terbutaline	Intravenous Nitroglycerine
Arm/Group Description	0.25 mL of Intravenous Terbutaline 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.	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. 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.
Measure Participants	3	2
Count of Participants [Participants]	0 0%	0 0%

4. Secondary Outcome

Title	Tachycardia
Description	Number of participants that had tachycardia
Time Frame	average of 1 hour

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intravenous Terbutaline	Intravenous Nitroglycerine
Arm/Group Description	0.25 mL of Intravenous Terbutaline 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.	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. 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.
Measure Participants	3	2
Count of Participants [Participants]	2 66.7%	0 0%

Adverse Events

Arm/Group Title	Intravenous Terbutaline		Intravenous Nitroglycerine
Arm/Group Description	0.25 mL of Intravenous Terbutaline 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.		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. 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.
All Cause Mortality
	Intravenous Terbutaline		Intravenous Nitroglycerine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)
Serious Adverse Events
	Intravenous Terbutaline		Intravenous Nitroglycerine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)
Other (Not Including Serious) Adverse Events
	Intravenous Terbutaline		Intravenous Nitroglycerine
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/3 (0%)		0/2 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.