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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
34
intrathecal bupivacaine 7.5 mg
0.25 mg Terbutaline subcutaneously
Mount Sinai West
New York, New York, United States
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.
Time frame: Day 1
Time From Procedure to Delivery.
Number of days from procedure to delivery.
Time frame: 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.
Time frame: 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.
Time frame: Day 1
Number of Adverse Events During Procedure
Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption.
Time frame: Day 1
Newborn Birth Weight
Newborn birth weight in grams.
Time frame: 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.
Time frame: 7 minutes and 9 minutes after delivery
Cord pH
Arterial cord pH level
Time frame: Day 1
Number of NICU Admission
Number of patients whose neonate was admitted to the NICU in each group.
Time frame: Day 1
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