Success of External Cephalic Version Study

Mount Sinai Health System

Status and phase: Terminated; Phase 4

Conditions: External Cephalic Version

Treatments: Drug: Bupivacaine; Drug: Terbutaline

Study type: Interventional

Funder types: Other

Identifiers

NCT03106753

GCO 17-0236

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Spinal anesthesia immediately for ECV.

Active Comparator group

Description:

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.

Treatment:

Drug: Bupivacaine

Drug: Terbutaline

Spinal anesthesia if no intervention fails for ECV.

Experimental group

Description:

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.

Treatment:

Drug: Bupivacaine

Drug: Terbutaline