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 range18 Years

SexFEMALE

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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

✕. Pregnancy diseases such as gestational hypertension, preeclampsia and gestational diabetes.
✕. Contraindications to neuraxial analgesia: thrombocytopenia \< 70 x 109/L, spinal cord anomalies, anticoagulation therapy, etc.
✕. Known important fetal anomalies.
✕. Allergy to any of the medications used in the study.
✕. Suspected chorioamnionitis with spontaneous premature rupture of membranes (PROM).
✕. Difficulty understanding and speaking French.

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