Trial Outcomes & Findings for Leg Elevation to Prevent Hypotension During Labor (NCT NCT05674838)

NCT ID: NCT05674838

Last Updated: 2025-08-29

Results Overview

SBP requiring treatment by the anesthesia provider

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 102 participants
• Primary outcome timeframe: 40 minutes
• Results posted on: 2025-08-29

Participant Flow

Participant milestones

Measure	Experimental Intervention - Leg Elevation Arm Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge and both of her legs elevated on an orange peanut ball. She will remain in this position for approximately 40 minutes.	Control - No Leg Elevation Arm Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge. She will remain in this position for approximately 40 minutes.
Overall Study STARTED	58	44
Overall Study COMPLETED	54	38
Overall Study NOT COMPLETED	4	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Experimental Intervention - Leg Elevation Arm n=54 Participants Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge and both of her legs elevated on an orange peanut ball. She will remain in this position for approximately 40 minutes.	Control - No Leg Elevation Arm n=38 Participants Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge. She will remain in this position for approximately 40 minutes.	Total n=92 Participants Total of all reporting groups
Age, Continuous	30.4 years STANDARD_DEVIATION 4.4 • n=54 Participants	29.9 years STANDARD_DEVIATION 4.2 • n=38 Participants	30.2 years STANDARD_DEVIATION 4.3 • n=92 Participants
Sex: Female, Male Female	54 Participants n=54 Participants	38 Participants n=38 Participants	92 Participants n=92 Participants
Sex: Female, Male Male	0 Participants n=54 Participants	0 Participants n=38 Participants	0 Participants n=92 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 40 minutes

SBP requiring treatment by the anesthesia provider

Outcome measures

Measure	Experimental Intervention - Leg Elevation Arm n=54 Participants Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge and both of her legs elevated on an orange peanut ball. She will remain in this position for approximately 40 minutes.	Control - No Leg Elevation Arm n=38 Participants Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge. She will remain in this position for approximately 40 minutes.
Number of Patients With Maternal Hypotension Requiring Treatment Maternal Hypotension requiring Intervention	6 Participants	11 Participants
Number of Patients With Maternal Hypotension Requiring Treatment No Maternal Hypotension requiring Intervention	48 Participants	27 Participants

PRIMARY outcome

Timeframe: 40 minutes

Any late or prolonged decelerations on the fetal heart tracings

Outcome measures

Measure	Experimental Intervention - Leg Elevation Arm n=54 Participants Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge and both of her legs elevated on an orange peanut ball. She will remain in this position for approximately 40 minutes.	Control - No Leg Elevation Arm n=38 Participants Immediately after epidural placement, patient will be placed in a left tilt position with her hip on a wedge. She will remain in this position for approximately 40 minutes.
Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings Late or Prolonged Decelerations	10 Participants	12 Participants
Number of Patients With Late or Prolonged Decelerations on the Fetal Heart Tracings No Late or Prolonged Decelerations	44 Participants	26 Participants

Adverse Events

Experimental Intervention - Leg Elevation Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - No Leg Elevation Arm

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

Nurse Researcher

TriHealth

Phone: 513-569-6191

Email: Rachel_Baker2@trihealth.com

Results disclosure agreements

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