Not provided
Not provided
Not provided
Not provided
Not provided
Interim analysis to assess concern for spinal anesthesia and increased cesarean delivery rate.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal anesthesia immediately for ECV. | Active Comparator | 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. |
|
| Spinal anesthesia if no intervention fails for ECV. | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug | intrathecal bupivacaine 7.5 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Time From Procedure to Delivery. | Number of days from procedure to delivery. | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Natalie Porat, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai West | New York | New York | 10019 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25828903 | Background | 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. | |
| 27131581 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 | Spinal Anesthesia if no Intervention Fails for ECV. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Day 1 |
|
1 Day
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bradycardia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Natalie Porat | Icahn School of Medicine at Mount Sinai | 973-919-6166 | poratnat@gmail.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 21, 2016 | May 17, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| D013726 | Terbutaline |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Terbutaline | Drug | 0.25 mg Terbutaline subcutaneously |
|
| 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. | Day 1 |
| Number of Adverse Events During Procedure | Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption. | Day 1 |
| Newborn Birth Weight | Newborn birth weight in grams. | 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. | 7 minutes and 9 minutes after delivery |
| Cord pH | Arterial cord pH level | Day 1 |
| Number of NICU Admission | Number of patients whose neonate was admitted to the NICU in each group. | Day 1 |
| 9822489 | Background | 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. |
| 10740339 | Background | 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. |
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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Parity | The number of pregnancies reaching viable gestational age | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Secondary | Time From Procedure to Delivery. | Number of days from procedure to delivery. | 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. | Posted | Mean | Standard Deviation | hours | up to day 42 |
|
|
|
| Secondary | Number of Participants With Various Mode of Delivery | Mode of delivery as incidence of spontaneous vaginal delivery, operative vaginal delivery, or cesarean section. | 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. | Posted | Count of Participants | Participants | up to day 42 |
|
|
|
| Secondary | Numeric Rating Scale (NRS-11) | Patient discomfort rated with NRS-11. Total scale from 0-10, with higher score indicating more pain. | Only those participants who underwent a second procedure completed the NRS-11 a second time. | Posted | Mean | Standard Deviation | score on a scale | Day 1 |
|
|
|
| Secondary | Number of Adverse Events During Procedure | Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption. | 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. | Posted | Number | events | Day 1 |
|
|
|
| Secondary | Newborn Birth Weight | Newborn birth weight in grams. | 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. | Posted | Mean | Standard Deviation | grams | Day 1 of delivery |
|
|
|
| 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. | 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. | Posted | Count of Participants | Participants | 7 minutes and 9 minutes after delivery |
|
|
|
| Secondary | Cord pH | Arterial cord pH level | Data results only for those who had arterial cord pH blood drawn, | Posted | Mean | Standard Deviation | pH | Day 1 |
|
|
|
| Secondary | Number of NICU Admission | Number of patients whose neonate was admitted to the NICU in each group. | 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. | Posted | Count of Participants | Participants | Day 1 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 11 |
| 17 |
| EG001 | 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. 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. | 0 | 17 | 0 | 17 | 5 | 17 |
| Nonreactive tracking | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Abruption | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Cesarean Section | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
| Hypotension | Cardiac disorders | Non-systematic Assessment |
|
| Transient bradycardia | Pregnancy, puerperium and perinatal conditions | Non-systematic Assessment |
|
Not provided
Not provided
Not provided
| D000588 |
| Amines |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| Cesarean Section |
|
| Second procedure |
|
|