Success of External Cephalic Version Study

External Cephalic Version Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03106753
• Other study ID #: GCO 17-0236
• Status: Terminated
• Phase: Phase 4
• Start date: April 12, 2017
• Est. completion date: May 5, 2018

Study information

• Verified date: September 2020
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: May 5, 2018
• Est. primary completion date: May 5, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• External Cephalic Version

Intervention

Drug:
• Bupivacaine
intrathecal bupivacaine 7.5 mg
• Terbutaline
0.25 mg Terbutaline subcutaneously

Locations

Country	Name	City	State
United States	Mount Sinai West	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai

Country where clinical trial is conducted

United States, 

References & Publications (4)

Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2015 Apr 1;(4):CD000083. doi: 10.1002/14651858.CD000083.pub3. Review. — View Citation

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. Review. Erratum in: Am J Obstet Gynecol. 2017 Mar;216(3):315. — View Citation

Neiger R, Hennessy MD, Patel M. Reattempting failed external cephalic version under epidural anesthesia. Am J Obstet Gynecol. 1998 Nov;179(5):1136-9. — View Citation

Rozenberg P, Goffinet F, de Spirlet M, Durand-Zaleski I, Blanié 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time From Procedure to Delivery.	Number of days from procedure to delivery.	up to day 42
Secondary	Number of Participants With Various Mode of Delivery	Mode of delivery as incidence of spontaneous vaginal delivery, operative vaginal delivery, or cesarean section.	up to day 42
Secondary	Numeric Rating Scale (NRS-11)	Patient discomfort rated with NRS-11. Total scale from 0-10, with higher score indicating more pain.	Day 1
Secondary	Number of Adverse Events During Procedure	Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption.	Day 1
Secondary	Newborn Birth Weight	Newborn birth weight in grams.	Day 1 of delivery
Secondary	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.	7 minutes and 9 minutes after delivery
Secondary	Cord pH	Arterial cord pH level	Day 1
Secondary	Number of NICU Admission	Number of patients whose neonate was admitted to the NICU in each group.	Day 1