Trial Outcomes & Findings for Success of External Cephalic Version Study (NCT NCT03106753)
NCT ID: NCT03106753
Last Updated: 2020-10-09
Results Overview
Success rate will be measured by comparing the percentage of successful external cephalic versions in each group.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
34 participants
Primary outcome timeframe
Day 1
Results posted on
2020-10-09
Participant Flow
Participant milestones
| Measure |
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. Under ultrasound guidance the provider 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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
The patient was administered terbutaline 0.25 mg subcutaneously and the version was attempted using the same procedure. If successful, the patient was monitored for 30 minutes and discharged if fetal and maternal status is reassuring. If the attempt fails, the patient was administered spinal anesthesia and the same maneuvers attempted. Once attempt is complete, whether successful or not, the patient was 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.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
17
|
|
Overall Study
COMPLETED
|
17
|
16
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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. Under ultrasound guidance the provider 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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
The patient was administered terbutaline 0.25 mg subcutaneously and the version was attempted using the same procedure. If successful, the patient was monitored for 30 minutes and discharged if fetal and maternal status is reassuring. If the attempt fails, the patient was administered spinal anesthesia and the same maneuvers attempted. Once attempt is complete, whether successful or not, the patient was 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.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Success of External Cephalic Version Study
Baseline characteristics by cohort
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=17 Participants
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.
|
Total
n=34 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 3.6 • n=99 Participants
|
34.1 years
STANDARD_DEVIATION 4.6 • n=107 Participants
|
33.7 years
STANDARD_DEVIATION 4.1 • n=206 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
31 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Parity
0
|
13 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
26 Participants
n=206 Participants
|
|
Parity
1
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Parity
2
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: 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.
Success rate will be measured by comparing the percentage of successful external cephalic versions in each group.
Outcome measures
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=17 Participants
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.
|
|---|---|---|
|
Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation.
Nulliparous
|
4 Participants
|
5 Participants
|
|
Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation.
Multiparous
|
3 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: up to day 42Population: 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.
Number of days from procedure to delivery.
Outcome measures
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=17 Participants
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.
|
|---|---|---|
|
Time From Procedure to Delivery.
|
12.6 hours
Standard Deviation 9.5
|
11.3 hours
Standard Deviation 7.7
|
SECONDARY outcome
Timeframe: up to day 42Population: 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.
Mode of delivery as incidence of spontaneous vaginal delivery, operative vaginal delivery, or cesarean section.
Outcome measures
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With Various Mode of Delivery
Spontaneous Vaginal Delivery
|
6 Participants
|
6 Participants
|
|
Number of Participants With Various Mode of Delivery
Operative Vaginal Delivery
|
0 Participants
|
1 Participants
|
|
Number of Participants With Various Mode of Delivery
Cesarean Section
|
11 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Only those participants who underwent a second procedure completed the NRS-11 a second time.
Patient discomfort rated with NRS-11. Total scale from 0-10, with higher score indicating more pain.
Outcome measures
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=17 Participants
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.
|
|---|---|---|
|
Numeric Rating Scale (NRS-11)
First procedure
|
2.0 score on a scale
Standard Deviation 2.3
|
6.1 score on a scale
Standard Deviation 2.0
|
|
Numeric Rating Scale (NRS-11)
Second procedure
|
—
|
2.2 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption.
Outcome measures
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=17 Participants
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.
|
|---|---|---|
|
Number of Adverse Events During Procedure
|
11 events
|
5 events
|
SECONDARY outcome
Timeframe: Day 1 of deliveryPopulation: 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.
Newborn birth weight in grams.
Outcome measures
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=16 Participants
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.
|
|---|---|---|
|
Newborn Birth Weight
|
3321.6 grams
Standard Deviation 496.5
|
3257.7 grams
Standard Deviation 337.8
|
SECONDARY outcome
Timeframe: 7 minutes and 9 minutes after deliveryPopulation: 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.
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.
Outcome measures
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=16 Participants
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.
|
|---|---|---|
|
Number of Participants With Newborns With Apgar Score 7 or 9
9
|
16 Participants
|
15 Participants
|
|
Number of Participants With Newborns With Apgar Score 7 or 9
7
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Day 1Population: Data results only for those who had arterial cord pH blood drawn,
Arterial cord pH level
Outcome measures
| Measure |
Spinal Anesthesia Immediately for ECV.
n=8 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=7 Participants
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.
|
|---|---|---|
|
Cord pH
|
7.2 pH
Standard Deviation 0.1
|
7.2 pH
Standard Deviation 0.1
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
Number of patients whose neonate was admitted to the NICU in each group.
Outcome measures
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 Participants
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.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=16 Participants
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.
|
|---|---|---|
|
Number of NICU Admission
|
1 Participants
|
1 Participants
|
Adverse Events
Spinal Anesthesia Immediately for ECV.
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Spinal Anesthesia if no Intervention Fails for ECV.
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Spinal Anesthesia Immediately for ECV.
n=17 participants at risk
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.
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 waa what the researchers were looking at, the researchers were not comparing spinal versus no spinal.
|
Spinal Anesthesia if no Intervention Fails for ECV.
n=17 participants at risk
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.
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 waa what the researchers were looking at, the researchers were not comparing spinal versus no spinal.
|
|---|---|---|
|
Pregnancy, puerperium and perinatal conditions
Bradycardia
|
0.00%
0/17 • 1 Day
|
5.9%
1/17 • 1 Day
|
|
Pregnancy, puerperium and perinatal conditions
Nonreactive tracking
|
11.8%
2/17 • 1 Day
|
5.9%
1/17 • 1 Day
|
|
Pregnancy, puerperium and perinatal conditions
Abruption
|
5.9%
1/17 • 1 Day
|
0.00%
0/17 • 1 Day
|
|
Pregnancy, puerperium and perinatal conditions
Cesarean Section
|
17.6%
3/17 • 1 Day
|
5.9%
1/17 • 1 Day
|
|
Cardiac disorders
Hypotension
|
41.2%
7/17 • 1 Day
|
11.8%
2/17 • 1 Day
|
|
Pregnancy, puerperium and perinatal conditions
Transient bradycardia
|
47.1%
8/17 • 1 Day
|
11.8%
2/17 • 1 Day
|
Additional Information
Dr. Natalie Porat
Icahn School of Medicine at Mount Sinai
Phone: 973-919-6166
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place