Clinical trial NCT03106753: Success of External Cephalic Version 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: External Cephalic Version
Keywords: External Cephalic Version
neuraxial analgesia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2017-04-10
Enrollment: 34
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation.
timeFrame: Day 1
Secondary outcomes:
measure: Time From Procedure to Delivery.
timeFrame: up to day 42
measure: Number of Participants With Various Mode of Delivery
timeFrame: up to day 42
measure: Numeric Rating Scale (NRS-11)
timeFrame: Day 1
measure: Number of Adverse Events During Procedure
timeFrame: Day 1
measure: Newborn Birth Weight
timeFrame: Day 1 of delivery
measure: Number of Participants With Newborns With Apgar Score 7 or 9
timeFrame: 7 minutes and 9 minutes after delivery
measure: Cord pH
timeFrame: Day 1
measure: Number of NICU Admission
timeFrame: Day 1
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai West
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Natalie Porat, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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.
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. doi: 10.1016/s0002-9378(98)70120-6.
citation: 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.