Success of External Cephalic Version Study

• Sponsor: Icahn School of Medicine at Mount Sinai (Other)
• Overall Status: Terminated
• CT.gov ID: NCT03106753
• Collaborator: (none)
• Enrollment: 34
• Location: 1
• Arms: 2
• Actual Duration (Months): 12.7
• Patients Per Site Per Month: 2.7

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
External Cephalic Version	Drug: Bupivacaine; Drug: Terbutaline	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 34 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Success of External Cephalic Version With Immediate Spinal Anesthesia Versus Spinal Anesthesia When Attempt Without Anesthesia Has Failed: A Randomized Controlled Trial
• Actual Study Start Date: Apr 12, 2017
• Actual Primary Completion Date: May 5, 2018
• Actual Study Completion Date: May 5, 2018

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Spinal anesthesia immediately for ECV. 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.	Drug: Bupivacaine; intrathecal bupivacaine 7.5 mg; Drug: Terbutaline; 0.25 mg Terbutaline subcutaneously
Experimental: Spinal anesthesia if no intervention fails for ECV. 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.	Drug: Bupivacaine; intrathecal bupivacaine 7.5 mg; Drug: Terbutaline; 0.25 mg Terbutaline subcutaneously

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. Time From Procedure to Delivery. [up to day 42]

   Number of days from procedure to delivery.

2. 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.

3. Numeric Rating Scale (NRS-11) [Day 1]

   Patient discomfort rated with NRS-11. Total scale from 0-10, with higher score indicating more pain.

4. Number of Adverse Events During Procedure [Day 1]

   Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption.

5. Newborn Birth Weight [Day 1 of delivery]

   Newborn birth weight in grams.

6. 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.

7. Cord pH [Day 1]

   Arterial cord pH level

8. Number of NICU Admission [Day 1]

   Number of patients whose neonate was admitted to the NICU in each group.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mount Sinai West	New York	New York	United States	10019

Sponsors and Collaborators

• Icahn School of Medicine at Mount Sinai

Investigators

• Principal Investigator: Natalie Porat, MD, Icahn School of Medicine at Mount Sinai

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 21, 2016

More Information

Publications

• Hofmeyr GJ, Kulier R, West HM. External cephalic version for breech presentation at term. Cochrane Database Syst Rev. 2015 Apr 1;(4):CD000083. doi: 10.1002/14651858.CD000083.pub3. Review.
• 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. Review. Erratum in: Am J Obstet Gynecol. 2017 Mar;216(3):315.
• Neiger R, Hennessy MD, Patel M. Reattempting failed external cephalic version under epidural anesthesia. Am J Obstet Gynecol. 1998 Nov;179(5):1136-9.
• Rozenberg P, Goffinet F, de Spirlet M, Durand-Zaleski I, Blanié 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.

• Responsible Party: Natalie Porat, Resident, Icahn School of Medicine at Mount Sinai
• ClinicalTrials.gov Identifier: NCT03106753
• Other Study ID Numbers: GCO 17-0236
• First Posted: Apr 10, 2017
• Last Update Posted: Oct 9, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Natalie Porat, Resident, Icahn School of Medicine at Mount Sinai: External Cephalic Version; neuraxial analgesia
• Additional relevant MeSH terms: Bupivacaine; Terbutaline

Study Results

Participant Flow

Arm/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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.	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.
Period Title: Overall Study
STARTED	17	17
COMPLETED	17	16
NOT COMPLETED	0	1

Baseline Characteristics

Arm/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.	Total
Arm/Group Description	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 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 of all reporting groups
Overall Participants	17	17	34
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	33.4 (3.6)	34.1 (4.6)	33.7 (4.1)
Sex: Female, Male (Count of Participants)
Female	17 100%	17 100%	34 100%
Male	0 0%	0 0%	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 5.9%	2 11.8%	3 8.8%
Not Hispanic or Latino	16 94.1%	15 88.2%	31 91.2%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	4 23.5%	2 11.8%	6 17.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	2 11.8%	2 5.9%
White	12 70.6%	10 58.8%	22 64.7%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 5.9%	3 17.6%	4 11.8%
Parity (Count of Participants)
0	13 76.5%	13 76.5%	26 76.5%
1	4 23.5%	3 17.6%	7 20.6%
2	0 0%	1 5.9%	1 2.9%

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Success Rate of External Cephalic Version to Cephalic Presentation.
Description	Success rate will be measured by comparing the percentage of successful external cephalic versions in each group.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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 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.
Measure Participants	17	17
Nulliparous	4 23.5%	5 29.4%
Multiparous	3 17.6%	3 17.6%

2. Secondary Outcome

Title	Time From Procedure to Delivery.
Description	Number of days from procedure to delivery.
Time Frame	up to day 42

Outcome Measure Data

Analysis Population Description

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/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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 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.
Measure Participants	17	17
Mean (Standard Deviation) [hours]	12.6 (9.5)	11.3 (7.7)

3. Secondary Outcome

Title	Number of Participants With Various Mode of Delivery
Description	Mode of delivery as incidence of spontaneous vaginal delivery, operative vaginal delivery, or cesarean section.
Time Frame	up to day 42

Outcome Measure Data

Analysis Population Description

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/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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 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.
Measure Participants	17	16
Spontaneous Vaginal Delivery	6 35.3%	6 35.3%
Operative Vaginal Delivery	0 0%	1 5.9%
Cesarean Section	11 64.7%	9 52.9%

4. Secondary Outcome

Title	Numeric Rating Scale (NRS-11)
Description	Patient discomfort rated with NRS-11. Total scale from 0-10, with higher score indicating more pain.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Only those participants who underwent a second procedure completed the NRS-11 a second time.

Arm/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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 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.
Measure Participants	17	17
First procedure	2.0 (2.3)	6.1 (2.0)
Second procedure	2.2 (2.9)

5. Secondary Outcome

Title	Number of Adverse Events During Procedure
Description	Number of total specific adverse events such as: fetal bradycardia, emergent cesarean section, or abruption.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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 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.
Measure Participants	17	17
Number [events]	11	5

6. Secondary Outcome

Title	Newborn Birth Weight
Description	Newborn birth weight in grams.
Time Frame	Day 1 of delivery

Outcome Measure Data

Analysis Population Description

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/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	Newborn of the patients that 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.	Newborns of the patient that 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.
Measure Participants	17	16
Mean (Standard Deviation) [grams]	3321.6 (496.5)	3257.7 (337.8)

7. Secondary Outcome

Title	Number of Participants With Newborns With Apgar Score 7 or 9
Description	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

Outcome Measure Data

Analysis Population Description

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/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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 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.
Measure Participants	17	16
7	1 5.9%	1 5.9%
9	16 94.1%	15 88.2%

8. Secondary Outcome

Title	Cord pH
Description	Arterial cord pH level
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

Data results only for those who had arterial cord pH blood drawn,

Arm/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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 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.
Measure Participants	8	7
Mean (Standard Deviation) [pH]	7.2 (0.1)	7.2 (0.1)

9. Secondary Outcome

Title	Number of NICU Admission
Description	Number of patients whose neonate was admitted to the NICU in each group.
Time Frame	Day 1

Outcome Measure Data

Analysis Population Description

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/Group Title	Spinal Anesthesia Immediately for ECV.	Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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 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.
Measure Participants	17	16
Count of Participants [Participants]	1 5.9%	1 5.9%

Adverse Events

Time Frame	1 Day
Arm/Group Title	Spinal Anesthesia Immediately for ECV.		Spinal Anesthesia if no Intervention Fails for ECV.
Arm/Group Description	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.		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.
All Cause Mortality
	Spinal Anesthesia Immediately for ECV.		Spinal Anesthesia if no Intervention Fails for ECV.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Serious Adverse Events
	Spinal Anesthesia Immediately for ECV.		Spinal Anesthesia if no Intervention Fails for ECV.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/17 (0%)		0/17 (0%)
Other (Not Including Serious) Adverse Events
	Spinal Anesthesia Immediately for ECV.		Spinal Anesthesia if no Intervention Fails for ECV.
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/17 (64.7%)		5/17 (29.4%)
Cardiac disorders
Hypotension	7/17 (41.2%)		2/17 (11.8%)
Pregnancy, puerperium and perinatal conditions
Bradycardia	0/17 (0%)		1/17 (5.9%)
Nonreactive tracking	2/17 (11.8%)		1/17 (5.9%)
Abruption	1/17 (5.9%)		0/17 (0%)
Cesarean Section	3/17 (17.6%)		1/17 (5.9%)
Transient bradycardia	8/17 (47.1%)		2/17 (11.8%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.