Success of External Cephalic Version Study

NCT03106753 | Terminated Phase 4 Results FDA Drug

• 1 other identifier: GCO 17-0236
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

External Cephalic Version

Keywords

External Cephalic Version; neuraxial analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Day 1

Secondary Outcomes (8)

• Time From Procedure to Delivery.

  up to day 42

• Number of Participants With Various Mode of Delivery

  up to day 42

• Numeric Rating Scale (NRS-11)

  Day 1

• Number of Adverse Events During Procedure

  Day 1

• Newborn Birth Weight

  Day 1 of delivery

Study Arms (2)

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.

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.

Drug: Bupivacaine; Drug: Terbutaline

Interventions

Bupivacaine DRUG

intrathecal bupivacaine 7.5 mg

Spinal anesthesia if no intervention fails for ECV.; Spinal anesthesia immediately for ECV.

Terbutaline DRUG

0.25 mg Terbutaline subcutaneously

Spinal anesthesia if no intervention fails for ECV.; Spinal anesthesia immediately for ECV.

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai West

New York, New York, 10019, United States

Location

Related Publications (4)

• 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.

  PMID: 25828903 BACKGROUND

• 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.

  PMID: 27131581 BACKGROUND

• 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.

  PMID: 9822489 BACKGROUND

• 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.

  PMID: 10740339 BACKGROUND

MeSH Terms

Interventions

Bupivacaine; Terbutaline

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Ethanolamines; Amino Alcohols; Alcohols

Results Point of Contact

• Title: Dr. Natalie Porat
• Organization: Icahn School of Medicine at Mount Sinai

poratnat@gmail.com

973-919-6166

Study Officials

• Natalie Porat, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 10, 2017
• Study Start: April 12, 2017
• Primary Completion: May 5, 2018
• Study Completion: May 5, 2018
• Last Updated: October 9, 2020
• Results First Posted: October 9, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)