Trial Outcomes & Findings for Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor (NCT NCT05250960)

Results Overview

SBP \<90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

109 participants

Primary outcome timeframe

1 hour

Results posted on

2025-04-25

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention - Sequential Compression Devices (SCD) Arm Patient will receive 1liter (L) of Lactated Ringers (LR) and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement SCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement	Control - no Sequential Compression Devices (SCD) Arm Patient will receive 1L of LR during and after epidural placement with no use of SCDs
Overall Study STARTED	53	56
Overall Study COMPLETED	53	56
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention - SCD Arm n=53 Participants Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement SCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement	Control - no SCD Arm n=56 Participants Patient will receive 1L of LR during and after epidural placement with no use of SCDs	Total n=109 Participants Total of all reporting groups
Age, Continuous	29.1 years n=53 Participants	28.5 years n=56 Participants	28.8 years n=109 Participants
Sex: Female, Male Female	53 Participants n=53 Participants	56 Participants n=56 Participants	109 Participants n=109 Participants
Sex: Female, Male Male	0 Participants n=53 Participants	0 Participants n=56 Participants	0 Participants n=109 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	53 participants n=53 Participants	56 participants n=56 Participants	109 participants n=109 Participants

PRIMARY outcome

Timeframe: 1 hour

SBP \<90mmHg or an SBP decrease more than 20% from baseline (physiological measure obtained via sphygmomanometer)

Outcome measures

Outcome measures
Measure	Intervention - SCD Arm n=53 Participants Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement SCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement	Control - no SCD Arm n=56 Participants Patient will receive 1L of LR during and after epidural placement with no use of SCDs
Hypotension	4 participants	4 participants

PRIMARY outcome

Timeframe: 1 hour

Category II fetal tracings - fetal heart tracings will be reviewed by two independent nurses who will document whether Category II tracings are present or not Category II tracings - The classification of Category II tracings includes the following: bradycardia with variability, tachycardia, minimal variability, no variability with no recurrent decelerations, marked variability, absence of induced accelerations even after fetal stimulation, recurrent variable decelerations with minimal or moderate baseline variability, prolonged decelerations lasting more than two minutes, but less than ten minutes, recurrent late decelerations with moderate variability, variable decelerations with other characteristics such as slow return to baseline, overshooting the baseline, or 'shoulders'

Outcome measures

Outcome measures
Measure	Intervention - SCD Arm n=53 Participants Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement SCD: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement	Control - no SCD Arm n=56 Participants Patient will receive 1L of LR during and after epidural placement with no use of SCDs
Category II Tracings	17 Participants	13 Participants

Adverse Events

Intervention - SCD Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control - no SCD 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

Rachel Baker

TriHealth

Phone: 513-569-6191

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place