CompletedNot Applicable

Dural Puncture Epidural VS Standard Epidural on Physician Top-ups During Labour Analgesia

Canada130 participantsStarted 2021-01-19

Plain-language summary

The purpose of this prospective randomized controlled study is to compare the number of physician top-up interventions during the first stage of labour between two different neuraxial analgesia techniques : the dural puncture epidural and the standard epidural.

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

. Healthy pregnant women (ASA 1 and 2) requesting epidural analgesia during labour.
. Primiparous and multiparous parturients at term gestation (37 to 42 weeks).
. Women 18 years old and older.
. Administration of epidural analgesia between 7am and 4pm on weekdays.
. Singleton and vertex presentation foetus.
. Cervical dilatation ≤ 5 cm.
. BMI ≤ 40.
. French speaking

Exclusion criteria

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.

What they're measuring

Need for 1 physician epidural top-up

Timeframe: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.

Trial details

NCT IDNCT04728048

SponsorCiusss de L'Est de l'Île de Montréal

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-09-30

View on ClinicalTrials.gov More Obstetric Pain trials