External Cephalic Version
Conditions
Keywords
External Cephalic Version, neuraxial analgesia
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.
Interventions
DRUGBupivacaine
intrathecal bupivacaine 7.5 mg
DRUGTerbutaline
0.25 mg Terbutaline subcutaneously
Sponsors
Icahn School of Medicine at Mount Sinai
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation. | Day 1 | Success rate will be measured by comparing the percentage of successful external cephalic versions in each group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Various Mode of Delivery | up to day 42 | Mode of delivery as incidence of spontaneous vaginal delivery, operative vaginal delivery, or cesarean section. |
| Numeric Rating Scale (NRS-11) | Day 1 | Patient discomfort rated with NRS-11. Total scale from 0-10, with higher score indicating more pain. |
| Number of Adverse Events During Procedure | Day 1 | Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption. |
| Time From Procedure to Delivery. | up to day 42 | Number of days from procedure to delivery. |
| Number of Participants With Newborns With Apgar Score 7 or 9 | 7 minutes and 9 minutes after delivery | 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. |
| Cord pH | Day 1 | Arterial cord pH level |
| Number of NICU Admission | Day 1 | Number of patients whose neonate was admitted to the NICU in each group. |
| Newborn Birth Weight | Day 1 of delivery | Newborn birth weight in grams. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Anesthesia Immediately for ECV. The patient had a spinal administered by the on call anesthesiologist using standard protocol (intrathecal bupivacaine 7.5 mg). The patient was then administered 0.25 mg Terbutaline subcutaneously and the ECV was attempted. | 17 |
| Spinal Anesthesia if no Intervention Fails for ECV. The patient was administered terbutaline 0.25 mg subcutaneously and the version was attempted. If the attempt fails, the patient was administered spinal anesthesia and the same maneuvers attempted. This group includes both those who did not require spinal anesthesia and those who subsequently require spinal anesthesia. | 17 |
| Total | 34 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Withdrawal by Subject | 0 | 1 |
Baseline characteristics
| Characteristic | Spinal Anesthesia Immediately for ECV. | Spinal Anesthesia if no Intervention Fails for ECV. | Total |
|---|---|---|---|
| Age, Continuous | 33.4 years STANDARD_DEVIATION 3.6 | 34.1 years STANDARD_DEVIATION 4.6 | 33.7 years STANDARD_DEVIATION 4.1 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 16 Participants | 15 Participants | 31 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Parity 0 | 13 Participants | 13 Participants | 26 Participants |
| Parity 1 | 4 Participants | 3 Participants | 7 Participants |
| Parity 2 | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 12 Participants | 10 Participants | 22 Participants |
| Sex: Female, Male Female | 17 Participants | 17 Participants | 34 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 17 |
| other Total, other adverse events | 11 / 17 | 5 / 17 |
| serious Total, serious adverse events | 0 / 17 | 0 / 17 |
Outcome results
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.
Time frame: Day 1
Population: The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that was what the researchers were looking at, the researchers were not comparing spinal versus no spinal.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia Immediately for ECV. | Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation. | Nulliparous | 4 Participants |
| Spinal Anesthesia Immediately for ECV. | Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation. | Multiparous | 3 Participants |
| Spinal Anesthesia if no Intervention Fails for ECV. | Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation. | Nulliparous | 5 Participants |
| Spinal Anesthesia if no Intervention Fails for ECV. | Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation. | Multiparous | 3 Participants |
Secondary
Cord pH
Arterial cord pH level
Time frame: Day 1
Population: Data results only for those who had arterial cord pH blood drawn,
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Anesthesia Immediately for ECV. | Cord pH | 7.2 pH | Standard Deviation 0.1 |
| Spinal Anesthesia if no Intervention Fails for ECV. | Cord pH | 7.2 pH | Standard Deviation 0.1 |
Secondary
Newborn Birth Weight
Newborn birth weight in grams.
Time frame: Day 1 of delivery
Population: The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that was what the researchers were looking at, the researchers were not comparing spinal versus no spinal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Anesthesia Immediately for ECV. | Newborn Birth Weight | 3321.6 grams | Standard Deviation 496.5 |
| Spinal Anesthesia if no Intervention Fails for ECV. | Newborn Birth Weight | 3257.7 grams | Standard Deviation 337.8 |
Secondary
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
Population: The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that was what the researchers were looking at, the researchers were not comparing spinal versus no spinal.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Anesthesia Immediately for ECV. | Number of Adverse Events During Procedure | 11 events |
| Spinal Anesthesia if no Intervention Fails for ECV. | Number of Adverse Events During Procedure | 5 events |
Secondary
Number of NICU Admission
Number of patients whose neonate was admitted to the NICU in each group.
Time frame: Day 1
Population: The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that was what the researchers were looking at, the researchers were not comparing spinal versus no spinal.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Spinal Anesthesia Immediately for ECV. | Number of NICU Admission | 1 Participants |
| Spinal Anesthesia if no Intervention Fails for ECV. | Number of NICU Admission | 1 Participants |
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.
Time frame: 7 minutes and 9 minutes after delivery
Population: The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that was what the researchers were looking at, the researchers were not comparing spinal versus no spinal.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia Immediately for ECV. | Number of Participants With Newborns With Apgar Score 7 or 9 | 7 | 1 Participants |
| Spinal Anesthesia Immediately for ECV. | Number of Participants With Newborns With Apgar Score 7 or 9 | 9 | 16 Participants |
| Spinal Anesthesia if no Intervention Fails for ECV. | Number of Participants With Newborns With Apgar Score 7 or 9 | 7 | 1 Participants |
| Spinal Anesthesia if no Intervention Fails for ECV. | Number of Participants With Newborns With Apgar Score 7 or 9 | 9 | 15 Participants |
Secondary
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
Population: The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that was what the researchers were looking at, the researchers were not comparing spinal versus no spinal.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Spinal Anesthesia Immediately for ECV. | Number of Participants With Various Mode of Delivery | Spontaneous Vaginal Delivery | 6 Participants |
| Spinal Anesthesia Immediately for ECV. | Number of Participants With Various Mode of Delivery | Operative Vaginal Delivery | 0 Participants |
| Spinal Anesthesia Immediately for ECV. | Number of Participants With Various Mode of Delivery | Cesarean Section | 11 Participants |
| Spinal Anesthesia if no Intervention Fails for ECV. | Number of Participants With Various Mode of Delivery | Spontaneous Vaginal Delivery | 6 Participants |
| Spinal Anesthesia if no Intervention Fails for ECV. | Number of Participants With Various Mode of Delivery | Operative Vaginal Delivery | 1 Participants |
| Spinal Anesthesia if no Intervention Fails for ECV. | Number of Participants With Various Mode of Delivery | Cesarean Section | 9 Participants |
Secondary
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
Population: Only those participants who underwent a second procedure completed the NRS-11 a second time.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Spinal Anesthesia Immediately for ECV. | Numeric Rating Scale (NRS-11) | First procedure | 2.0 score on a scale | Standard Deviation 2.3 |
| Spinal Anesthesia if no Intervention Fails for ECV. | Numeric Rating Scale (NRS-11) | First procedure | 6.1 score on a scale | Standard Deviation 2 |
| Spinal Anesthesia if no Intervention Fails for ECV. | Numeric Rating Scale (NRS-11) | Second procedure | 2.2 score on a scale | Standard Deviation 2.9 |
Secondary
Time From Procedure to Delivery.
Number of days from procedure to delivery.
Time frame: up to day 42
Population: The data was analyzed by group, not by type of intervention (which means that for the delayed spinal group it was combined). This was done on purpose because the researchers wanted to compare the groups as a whole since that was what the researchers were looking at, the researchers were not comparing spinal versus no spinal.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Spinal Anesthesia Immediately for ECV. | Time From Procedure to Delivery. | 12.6 hours | Standard Deviation 9.5 |
| Spinal Anesthesia if no Intervention Fails for ECV. | Time From Procedure to Delivery. | 11.3 hours | Standard Deviation 7.7 |