External Cephalic VersionPhase 2/3NCT02115256
Study to Evaluate is ECV Success is Improved and the Side Effects Reduced With the Use of IV NTGL Versus Terbutaline
A Phase 2/3 study testing Intravenous Terbutaline and Intravenous Nitroglycerine in people with External Cephalic Version, run by Yaakov Beilin at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- External Cephalic Version
- What is being tested?
- Intravenous Terbutaline and Intravenous Nitroglycerine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2014to Apr 2015
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Between 18-35 years of age
- 37 weeks gestation
- Breech presentation
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Icahn School of Medicine at Mount Sinai
New York, New York, 10029
About this study
Official title: Intravenous Terbutaline Versus Intravenous Nitroglycerine for External Cephalic Version: A Double-Blinded Randomized Controlled Trial in Nulliparous Women
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.
Read the 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.
- Conditions
- External Cephalic Version
- Being tested
- Intravenous Terbutaline, Intravenous Nitroglycerine
- Keywords
- External Cephalic Version, breech
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous TerbutalineDrug
Also called Terbutaline, Brethine, Bricanyl, Brethaire
0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline.
Intravenous NitroglycerineDrug
Also called Nitroglycerine, Nitroglycerin, Trinitroglycerin, Trinitroglycerine
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.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous Terbutaline | Active comparator | 0.25 mL of Intravenous Terbutaline Receives: Drug: Intravenous Terbutaline |
| Intravenous Nitroglycerine | Active comparator | 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. Receives: Drug: Intravenous Nitroglycerine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful Version of the Fetus Into the Vertex Position
Number of participants that had successful version of the fetus into the vertex position.
Measured: average of 1 hour
Secondary outcomes (3)
Hypotension
Number of participants with hypotension
Measured: average of 1 hour
Need for Cesarean Delivery
Number of participants that needed a cesarean delivery
Measured: average of 1 hour
Tachycardia
Number of participants that had tachycardia
Measured: average of 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2014 (estimated)
- Study startJul 2014
- Primary completionApr 2015
- Study completionApr 2015
Why it stopped: difficult recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for External Cephalic VersionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yaakov Beilin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yaakov Beilin, Icahn School of Medicine at Mount Sinai
- Investigators
- Yaakov Beilin, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115256
- Sponsor's protocol ID
- GCO 14-0636
- Status last verified
- May 2017
- First submitted
- 13 Apr 2014
- Last updated
- 14 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Terbutaline Versus Intravenous Nitroglycerine for External Cephalic Version: A Double-Blinded Randomized Controlled Trial in Nulliparous Women
- ClinicalTrials.gov ID
- NCT02115256
- Acronym / sponsor ID
- GCO 14-0636
- Conditions
- External Cephalic Version
- Keywords
- External Cephalic Version, breech
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult recruitment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Yaakov BeilinUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 16 Apr 2014 (estimated)
- Results
- Posted 14 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous Terbutaline | Active comparator | Drug: Intravenous Terbutaline0.25 mL of Intravenous Terbutaline |
| Intravenous Nitroglycerine | Active comparator | Drug: Intravenous NitroglycerineIV 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Female
- Between 18-35 years of age
- 37 weeks gestation
- Breech presentation
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intravenous TerbutalineAlso: Terbutaline, Brethine, Bricanyl, Brethaire0.25 mL of Intravenous Terbutaline. This will be followed 3 minutes later by an injection of 0.25 mL IV of normal saline. | Drug | Intravenous Terbutaline |
| Intravenous NitroglycerineAlso: Nitroglycerine, Nitroglycerin, Trinitroglycerin, TrinitroglycerineThe 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. | Drug | Intravenous Nitroglycerine |
Primary outcome
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.
3 secondary outcomes
Hypotension
Time frame: average of 1 hour
Need for Cesarean Delivery
Time frame: average of 1 hour
Tachycardia
Time frame: average of 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for External Cephalic Version
Recruiting
Mindfulness-based Intervention Prior to External Cephalic Version
Breech Presentation in Pregnancy, External Cephalic Version
Recruiting
Use of Propofol as a Sedative Agent Versus Spinal Analgesia With Bupivacaine in External Cephalic Version
Pregnancy Complications
Not yet recruitingObservational study
Ultrasound Parameters for the Outcome Prediction of External Cephalic Version for Fetuses with Breech Presentation
Breech Fetal Presentation, Breech Presentation of Fetus with Successful Version
Recruiting
An Informative Video Before Planned External Cephalic Version
Breech Presentation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yaakov Beilin, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Intravenous Terbutaline and Intravenous Nitroglycerine in people with External Cephalic Version, run by Yaakov Beilin at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful Version of the Fetus Into the Vertex Position (time frame: average of 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2017.