External Cephalic VersionPhase 4NCT03106753

Success of External Cephalic Version Study

A Phase 4 study testing Bupivacaine and Terbutaline in people with External Cephalic Version, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Who is it for?: Ages 18 to 60 years, women only
Conditions the study is for: External Cephalic Version
What is being tested?: Bupivacaine and Terbutaline
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 34 participants
Where: 1 siteUnited States
Study dates: 12 Apr 2017to 5 May 2018
Phase: Phase 4
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 60 years
Women only
No healthy volunteers
Adult

Who may be able to join

Patients included are those with singleton pregnancies of at least 37 weeks gestation in nonvertex presentation with no contraindication for a vaginal delivery.
Membranes must be intact with a minimum of a 2x2 pocket and Category 1 non-stress test.

Who cannot join

All patients with a contraindication for a vaginal delivery will be excluded from the study.
Patients with gross fetal anomalies or uterine malformations.
Patients with contraindications to neuraxial anesthesia or allergies to any of the study medications will also be excluded.

Trial locations and contacts

1 site in 1 country.

United States1 site

Mount Sinai West
New York, New York, 10019

Other trials in United States

About this study

Official title: Success of External Cephalic Version With Immediate Spinal Anesthesia Versus Spinal Anesthesia When Attempt Without Anesthesia Has Failed: A Randomized Controlled Trial

The purpose of this study is to determine the best way to optimize the success of external cephalic version (turning the baby from the outside). Attempting to turn babies in-utero is recommended because it may decrease the risk of needing a cesarean section for abnormal presentation. While the study team knows that this procedure can be effective, the study team still has some un-answered questions as to the best way to perform this procedure to increase the chance of success. Many prior studies have shown that using spinal anesthesia (a shot of medication placed in your back to numb and relax the abdomen) can increase the success rate of a version. This ultimately has led to the finding that using this anesthesia can decrease the rate of cesarean section. However, there have been only a small number of studies assessing the success rate if spinal anesthesia is used only in the event that without it fails. Therefore the study team is going to compare patients who receive spinal anesthesia with those who only receive spinal anesthesia if the procedure to turn the baby (ECV) fails without it.

Read the detailed description

Breech presentation occurs in approximately 3-4% of term pregnancies and leads to one of the most common indications for cesarean delivery. Attempting an external cephalic version (ECV) significantly increases the chance of cephalic presentation at time of delivery and reduces the chance of cesarean section. Since ECV does in fact reduce the rate of cesarean section, many studies have sought to determine the best method to perform the procedure to optimize the chance of success. A recent meta-analysis concluded that administration of neuraxial analgesia significantly increases the success rate of ECV and also increases the incidence of vaginal delivery. However, there have been only 2 prospective studies and no randomized trials that evaluated the success of ECV using neuraxial analgesia only when initial attempt without it has failed. Therefore, the study team designed a randomized controlled trial with two groups: Group 1- patients receiving spinal anesthesia immediately versus Group 2- patients attempting ECV without spinal anesthesia with reattempt using a spinal if first attempt fails. This study will be conducted on labor and delivery at Mount Sinai West hospital. Patients who present to labor and delivery at term for ECV will be approached for enrollment and those who consent to be part of the study would be randomized into a group. ECV will then be attempted and delivery and neonatal outcomes will be collected. Patients will likely be enrolled in the study from time of version (approximately 37 weeks) until postpartum. This study will take approximately 1-2 years given the ECV rate.

Conditions: External Cephalic Version
Being tested: Bupivacaine, Terbutaline
Keywords: External Cephalic Version, neuraxial analgesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BupivacaineDrug
intrathecal bupivacaine 7.5 mg
TerbutalineDrug
0.25 mg Terbutaline subcutaneously

Study groups in NCT03106753
Study group	Role	What they receive
Spinal anesthesia immediately for ECV.	Active comparator	The patient will have a spinal administered by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg). The patient will then be administered 0.25 mg Terbutaline subcutaneously and the ECV will be attempted. Under ultrasound guidance the provider will attempt to lift the breech upward from the pelvis with one hand and guide the head with the other hand to produce a forward roll. If forward roll fails, a backward roll somersault may be attempted. ECV attempt will be abandoned if there is significant fetal bradycardia, discomfort to the patient, or if the procedure cannot be completed easily with these maneuvers. Once attempt is complete, whether successful or not, the patient will be monitored for a minimum of 30 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only if fetal and maternal status is reassuring. Receives: Drug: Bupivacaine; Drug: Terbutaline
Spinal anesthesia if no intervention fails for ECV.	Experimental	The patient will be administered terbutaline 0.25 mg subcutaneously and the version will be attempted using the same procedure as above. If successful, the patient will be monitored for 30 minutes and discharged if fetal and maternal status is reassuring. If the attempt fails, the patient will be administered spinal anesthesia as above and the same maneuvers will be attempted. Once attempt is complete, whether successful or not, the patient will be monitored for a minimum of 30 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only if fetal and maternal status is reassuring. Receives: Drug: Bupivacaine; Drug: Terbutaline

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation.
Success rate will be measured by comparing the percentage of successful external cephalic versions in each group.
Measured: Day 1

Secondary outcomes (8)

Time From Procedure to Delivery.
Number of days from procedure to delivery.
Measured: up to day 42
Number of Participants With Various Mode of Delivery
Mode of delivery as incidence of spontaneous vaginal delivery, operative vaginal delivery, or cesarean section.
Measured: up to day 42
Numeric Rating Scale (NRS-11)
Patient discomfort rated with NRS-11. Total scale from 0-10, with higher score indicating more pain.
Measured: Day 1
Number of Adverse Events During Procedure
Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption.
Measured: Day 1
Newborn Birth Weight
Newborn birth weight in grams.
Measured: Day 1 of delivery
Number of Participants With Newborns With Apgar Score 7 or 9
Newborns with Apgar Score 7 or 9 at 5 minutes after delivery. The Apgar score is based on a total score of 1 to 10. The higher the score, the better the baby is doing after birth. A score of 7, 8, or 9 is normal and is a sign that the newborn is in good health.
Measured: 7 minutes and 9 minutes after delivery
Cord pH
Arterial cord pH level
Measured: Day 1
Number of NICU Admission
Number of patients whose neonate was admitted to the NICU in each group.
Measured: Day 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Apr 20175 May 2018

First posted10 Apr 2017
Study start12 Apr 2017
Primary completion5 May 2018
Study completion5 May 2018

Why it stopped: Interim analysis to assess concern for spinal anesthesia and increased cesarean delivery rate.

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.
Publications (4)Papers the sponsor has linked to this study.
Other trials for External Cephalic VersionStudies of the same condition, open and under way.
More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 34 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03106753
Sponsor's protocol ID: GCO 17-0236
Status last verified: Sep 2020
First submitted: 27 Mar 2017
Last updated: 9 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2015 Apr 1;2015(4):CD000083. doi: 10.1002/14651858.CD000083.pub3.
PubMed 25828903
Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27.
PubMed 27131581
Neiger R, Hennessy MD, Patel M. Reattempting failed external cephalic version under epidural anesthesia. Am J Obstet Gynecol. 1998 Nov;179(5):1136-9. doi: 10.1016/s0002-9378(98)70120-6.
PubMed 9822489
Rozenberg P, Goffinet F, de Spirlet M, Durand-Zaleski I, Blanie P, Fisher C, Lang AC, Nisand I. External cephalic version with epidural anaesthesia after failure of a first trial with beta-mimetics. BJOG. 2000 Mar;107(3):406-10. doi: 10.1111/j.1471-0528.2000.tb13238.x.
PubMed 10740339

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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

All External Cephalic Version trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Success of External Cephalic Version With Immediate Spinal Anesthesia Versus Spinal Anesthesia When Attempt Without Anesthesia Has Failed: A Randomized Controlled Trial
ClinicalTrials.gov ID: NCT03106753
Acronym / sponsor ID: GCO 17-0236
Conditions: External Cephalic Version
Keywords: External Cephalic Version, neuraxial analgesia
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Interim analysis to assess concern for spinal anesthesia and increased cesarean delivery rate.
Enrolment: 34 participants (actual)
Lead sponsor: Icahn School of Medicine at Mount SinaiUniversity, hospital or other
Study start: 12 Apr 2017 (actual)
Primary completion: 5 May 2018 (actual)
Study completion: 5 May 2018 (actual)
First posted: 10 Apr 2017 (actual)
Results: Posted 9 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Spinal anesthesia immediately for ECV.	Active comparator	Drug: Bupivacaine, Drug: TerbutalineThe patient will have a spinal administered by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg). The patient will then be administered 0.25 mg Terbutaline subcutaneously and the ECV will be attempted. Under ultrasound guidance the provider will attempt to lift the breech upward from the pelvis with one hand and guide the head with the other hand to produce a forward roll. If forward roll fails, a backward roll somersault may be attempted. ECV attempt will be abandoned if there is significant fetal bradycardia, discomfort to the patient, or if the procedure cannot be completed easily with these maneuvers. Once attempt is complete, whether successful or not, the patient will be monitored for a minimum of 30 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only if fetal and maternal status is reassuring.
Spinal anesthesia if no intervention fails for ECV.	Experimental	Drug: Bupivacaine, Drug: TerbutalineThe patient will be administered terbutaline 0.25 mg subcutaneously and the version will be attempted using the same procedure as above. If successful, the patient will be monitored for 30 minutes and discharged if fetal and maternal status is reassuring. If the attempt fails, the patient will be administered spinal anesthesia as above and the same maneuvers will be attempted. Once attempt is complete, whether successful or not, the patient will be monitored for a minimum of 30 minutes, and will be discharged once they are able to walk, void, and tolerate PO intake, only if fetal and maternal status is reassuring.

Who may qualify

Ages: 18 to 60 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Patients included are those with singleton pregnancies of at least 37 weeks gestation in nonvertex presentation with no contraindication for a vaginal delivery.
Membranes must be intact with a minimum of a 2x2 pocket and Category 1 non-stress test.

Key exclusion criteria (3 listed)

All patients with a contraindication for a vaginal delivery will be excluded from the study.
Patients with gross fetal anomalies or uterine malformations.
Patients with contraindications to neuraxial anesthesia or allergies to any of the study medications will also be excluded.

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
Bupivacaineintrathecal bupivacaine 7.5 mg	Drug	Spinal anesthesia if no intervention fails for ECV., Spinal anesthesia immediately for ECV.
Terbutaline0.25 mg Terbutaline subcutaneously	Drug	Spinal anesthesia if no intervention fails for ECV., Spinal anesthesia immediately for ECV.

Primary outcome

Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation.
Time frame: Day 1
Success rate will be measured by comparing the percentage of successful external cephalic versions in each group.

8 secondary outcomes

Time From Procedure to Delivery.
Time frame: up to day 42
Number of Participants With Various Mode of Delivery
Time frame: up to day 42
Numeric Rating Scale (NRS-11)
Time frame: Day 1
Number of Adverse Events During Procedure
Time frame: Day 1
Newborn Birth Weight
Time frame: Day 1 of delivery
Number of Participants With Newborns With Apgar Score 7 or 9
Time frame: 7 minutes and 9 minutes after delivery
Cord pH
Time frame: Day 1
Number of NICU Admission
Time frame: Day 1

Results and safety

Results posted to the registry on 9 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Anesthesia Immediately for ECV.	17	17
Spinal Anesthesia if no Intervention Fails for ECV.	17	16

Primary outcome: Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation.

Time frame: Day 1. Count of participants. Unit: Participants

Measure	Spinal Anesthesia Immediately for ECV. n = 17	Spinal Anesthesia if no Intervention Fails for ECV. n = 17
Nulliparous	4	5
Multiparous	3	3

Population analysed: The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that was what the researchers were looking at, the researchers were not comparing spinal versus no spinal.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 Day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Anesthesia Immediately for ECV.	0 of 17 (0%)	11 of 17 (64.7%)	0 of 17
Spinal Anesthesia if no Intervention Fails for ECV.	0 of 17 (0%)	5 of 17 (29.4%)	0 of 17

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 25828903Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2015 Apr 1;2015(4):CD000083. doi: 10.1002/14651858.CD000083.pub3.
Background: PubMed 27131581Magro-Malosso ER, Saccone G, Di Tommaso M, Mele M, Berghella V. Neuraxial analgesia to increase the success rate of external cephalic version: a systematic review and meta-analysis of randomized controlled trials. Am J Obstet Gynecol. 2016 Sep;215(3):276-86. doi: 10.1016/j.ajog.2016.04.036. Epub 2016 Apr 27.
Background: PubMed 9822489Neiger R, Hennessy MD, Patel M. Reattempting failed external cephalic version under epidural anesthesia. Am J Obstet Gynecol. 1998 Nov;179(5):1136-9. doi: 10.1016/s0002-9378(98)70120-6.
Background: PubMed 10740339Rozenberg P, Goffinet F, de Spirlet M, Durand-Zaleski I, Blanie P, Fisher C, Lang AC, Nisand I. External cephalic version with epidural anaesthesia after failure of a first trial with beta-mimetics. BJOG. 2000 Mar;107(3):406-10. doi: 10.1111/j.1471-0528.2000.tb13238.x.
Individual participant dataSharing planned: No

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.

Natalie Porat, 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 4 study testing Bupivacaine and Terbutaline in people with External Cephalic Version, run by Icahn School of Medicine at Mount Sinai 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 2 inclusion and 3 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 9 Oct 2020. 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 phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 9 Oct 2020). 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?

Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation. (time frame: Day 1). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03106753, which also lists 4 linked publications.

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 9 Oct 2020.