Trial Outcomes & Findings for A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version (NCT NCT01991743)

NCT ID: NCT01991743

Last Updated: 2020-01-06

Results Overview

Rates of successful version evaluated among the 4 dose groups.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 240 participants
• Primary outcome timeframe: Completion of the procedure
• Results posted on: 2020-01-06

Participant Flow

A total of 240 patients were enrolled and allocated to one of four bupivicaine dose groups

Participant milestones

Measure	Drug:Group 2.5 Administration of 2.5 mg bupivacaine Group 2.5: Administration of bupivacaine 2.5 mg.	Group 5 Administration of 5 mg bupivacaine. Group 5: Administration of 5 mg bupivacaine	Group 7.5 Administration of 7.5mg bupivacaine. Group 7.5: Administration of 7.5 mg bupivacaine	Group 10 Administration of 10 mg bupivacaine. Group 10: Administration of 10mg bupivacaine.
Overall Study STARTED	60	60	60	60
Overall Study COMPLETED	60	60	59	60
Overall Study NOT COMPLETED	0	0	1	0

Reasons for withdrawal

Measure	Drug:Group 2.5 Administration of 2.5 mg bupivacaine Group 2.5: Administration of bupivacaine 2.5 mg.	Group 5 Administration of 5 mg bupivacaine. Group 5: Administration of 5 mg bupivacaine	Group 7.5 Administration of 7.5mg bupivacaine. Group 7.5: Administration of 7.5 mg bupivacaine	Group 10 Administration of 10 mg bupivacaine. Group 10: Administration of 10mg bupivacaine.
Overall Study external cephalic version not performed	0	0	1	0

Baseline Characteristics

A Trial Comparing Combined Spinal- Epidural Dosing Strategies for External Cephalic Version

Baseline characteristics by cohort

Measure	Drug:Group 2.5 n=60 Participants Administration of 2.5 mg bupivacaine Group 2.5: Administration of bupivacaine 2.5 mg.	Group 5 n=60 Participants Administration of 5 mg bupivacaine. Group 5: Administration of 5 mg bupivacaine	Group 7.5 n=59 Participants Administration of 7.5mg bupivacaine. Group 7.5: Administration of 7.5 mg bupivacaine	Group 10 n=60 Participants Administration of 10 mg bupivacaine. Group 10: Administration of 10mg bupivacaine.	Total n=239 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	60 Participants n=5 Participants	60 Participants n=7 Participants	59 Participants n=5 Participants	60 Participants n=4 Participants	239 Participants n=21 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Sex/Gender, Customized Female	60 Participants n=5 Participants	60 Participants n=7 Participants	59 Participants n=5 Participants	60 Participants n=4 Participants	239 Participants n=21 Participants
Sex: Female, Male Female	60 Participants n=5 Participants	60 Participants n=7 Participants	59 Participants n=5 Participants	60 Participants n=4 Participants	239 Participants n=21 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
BMI	29 kg/m^2 n=5 Participants	27 kg/m^2 n=7 Participants	28 kg/m^2 n=5 Participants	29 kg/m^2 n=4 Participants	28.5 kg/m^2 n=21 Participants
Estimated Gestational Age	263 days n=5 Participants	261 days n=7 Participants	261 days n=5 Participants	261 days n=4 Participants	261 days n=21 Participants
Duration of Procedure	7 minutes n=5 Participants	7 minutes n=7 Participants	11 minutes n=5 Participants	8 minutes n=4 Participants	7 minutes n=21 Participants

PRIMARY outcome

Timeframe: Completion of the procedure

Rates of successful version evaluated among the 4 dose groups.

Outcome measures

Measure	Drug:Group 2.5 n=60 Participants Administration of 2.5 mg bupivacaine Group 2.5: Administration of bupivacaine 2.5 mg.	Group 5 n=60 Participants Administration of 5 mg bupivacaine. Group 5: Administration of 5 mg bupivacaine	Group 7.5 n=59 Participants Administration of 7.5mg bupivacaine. Group 7.5: Administration of 7.5 mg bupivacaine	Group 10 n=60 Participants Administration of 10 mg bupivacaine. Group 10: Administration of 10mg bupivacaine.
Success Rate of External Cephalic Version	31 Participants	31 Participants	31 Participants	30 Participants

SECONDARY outcome

Timeframe: To time of delivery

Outcome measures

Measure	Drug:Group 2.5 n=60 Participants Administration of 2.5 mg bupivacaine Group 2.5: Administration of bupivacaine 2.5 mg.	Group 5 n=60 Participants Administration of 5 mg bupivacaine. Group 5: Administration of 5 mg bupivacaine	Group 7.5 n=59 Participants Administration of 7.5mg bupivacaine. Group 7.5: Administration of 7.5 mg bupivacaine	Group 10 n=60 Participants Administration of 10 mg bupivacaine. Group 10: Administration of 10mg bupivacaine.
Mode of Delivery Vaginal	26 count of participants	23 count of participants	28 count of participants	24 count of participants
Mode of Delivery Cesarean	34 count of participants	37 count of participants	31 count of participants	36 count of participants

SECONDARY outcome

Timeframe: To time of delivery

Outcome measures

Measure	Drug:Group 2.5 n=60 Participants Administration of 2.5 mg bupivacaine Group 2.5: Administration of bupivacaine 2.5 mg.	Group 5 n=60 Participants Administration of 5 mg bupivacaine. Group 5: Administration of 5 mg bupivacaine	Group 7.5 n=59 Participants Administration of 7.5mg bupivacaine. Group 7.5: Administration of 7.5 mg bupivacaine	Group 10 n=60 Participants Administration of 10 mg bupivacaine. Group 10: Administration of 10mg bupivacaine.
Indication of Cesarean Delivery Malposition	27 Participants	26 Participants	25 Participants	25 Participants
Indication of Cesarean Delivery Arrest of LAbor	4 Participants	4 Participants	2 Participants	4 Participants
Indication of Cesarean Delivery Nonreassuring Fetal Status	1 Participants	4 Participants	3 Participants	5 Participants
Indication of Cesarean Delivery Emergency	2 Participants	3 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: < 20 minutes

pain score during the procedure (Visual Analog Score: VAS=0 no pain -100 worst pain imaginable, scale)

Outcome measures

Measure	Drug:Group 2.5 n=60 Participants Administration of 2.5 mg bupivacaine Group 2.5: Administration of bupivacaine 2.5 mg.	Group 5 n=60 Participants Administration of 5 mg bupivacaine. Group 5: Administration of 5 mg bupivacaine	Group 7.5 n=59 Participants Administration of 7.5mg bupivacaine. Group 7.5: Administration of 7.5 mg bupivacaine	Group 10 n=60 Participants Administration of 10 mg bupivacaine. Group 10: Administration of 10mg bupivacaine.
Pain Score During the Procedure	12 units on a scale Interval 3.0 to 25.0	5 units on a scale Interval 1.0 to 18.0	4 units on a scale Interval 0.0 to 9.0	4 units on a scale Interval 0.0 to 10.0

SECONDARY outcome

Timeframe: <20 minutes

Obstetrician rating of participants abdominal relaxation (Visual analog score: VAS score= 0 no relaxation- complete relaxation 100)

Outcome measures

Measure	Drug:Group 2.5 n=60 Participants Administration of 2.5 mg bupivacaine Group 2.5: Administration of bupivacaine 2.5 mg.	Group 5 n=60 Participants Administration of 5 mg bupivacaine. Group 5: Administration of 5 mg bupivacaine	Group 7.5 n=59 Participants Administration of 7.5mg bupivacaine. Group 7.5: Administration of 7.5 mg bupivacaine	Group 10 n=60 Participants Administration of 10 mg bupivacaine. Group 10: Administration of 10mg bupivacaine.
Abdominal Relaxation	78 units on a scale Interval 63.0 to 91.0	83 units on a scale Interval 71.0 to 92.0	84 units on a scale Interval 77.0 to 94.0	88 units on a scale Interval 73.0 to 95.0

Adverse Events

Group 2.5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 7.5

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Group 10

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert J McCarthy

Northwestern University

Phone: 312-695-4976

Email: r-mccarthy@northwestern.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place