Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor (NCT05250960) | Clinical Trial Compass
CompletedNot Applicable
Pre-epidural Sequential Compression Devices (SCDs) to Prevent Hypotension During Labor
United States109 participantsStarted 2021-09-16
Plain-language summary
When hypotension is related to epidural placement, this can occur within 15-60 minutes after placement. The purpose of this study is to build upon this preliminary work and to use a randomized controlled trial to examine the effectiveness of SCDs in preventing hypotension among a larger sample of laboring women who receive an epidural analgesia. This study will use a randomized, non-blinded, controlled design with two arms:
* Arm 1: Patient will receive 1L of LR and have SCDs applied 15 minutes before epidural placement and will be removed 1 hour after epidural placement
* Arm 2: Patient will receive 1L of LR during and after epidural placement with no use of SCDs
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Laboring at Bethesda North Hospital Labor \& Delivery Unit
* Will receive epidural analgesia
* 37+ weeks gestation
* Singleton pregnancy
* Category 1 tracings only before epidural placement
Exclusion Criteria:
* Under 18 years old
* Does not speak English
* Unable to consent to involvement in the research study
* Diagnosed with fetal demise
* Diagnosis of pre-existing hypertension
* Diagnosis of gestational hypertension
* Diagnosis of pre-eclampsia
* Diagnosis of diabetes
* Breech presentation
* Contraindications to lower leg compression (ex: fractured bones in leg, cellulitis, lower limb amputation, etc.)
* Contraindications to receiving 1L of LR
* Blood pressure on admission systolic blood pressure (SBP)\>160 or diastolic blood pressure (DBP)\>110
* Fetal heart rate abnormalities before epidural
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.