NCT06442995: EPIMAG

Superiority Randomized Double-blind Controlled Trial of Epidural Magnesium Sulfate Addition Versus Placebo on the Occurrence of Acute Post-caesarean Urinary Retention

Recruiting now Phase 4 Last updated 22 December 2025

What this trial tests

Phase 4 trial testing Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space in Urinary Retention in 290 participants. Currently enrolling.

Timeline

16 January 2025

Primary endpoint
1 July 2027

1 December 2027

Quick facts

Lead sponsor	CHU de Reims
Phase	Phase 4
Status	Recruiting now
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	290
Start date	16 January 2025
Primary completion	1 July 2027
Estimated completion	1 December 2027
Sites	1 location across France

Drugs / interventions tested

• Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space — full drug profile →
• Injection of Isotonic saline + 2 mg morphine into the epidural space — full drug profile →

Conditions studied

• Urinary Retention — all drugs for Urinary Retention →

Sponsor

CHU de Reims — full company profile →

Who can join

18 and older, female only, with Urinary Retention. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• diuresis
  Time frame: 72 hours

Sponsor's own description

Peri-medullary anesthesia is the preferred anesthetic technique for Caesarean surgery. Compared with general anesthesia, it reduces maternal and fetal morbidity and mortality, as well as postoperative pain. However, this technique exposes the patient to the adverse effects of peri-medullary morphine, particularly the risk of postoperative urinary retention. Urinary retention during the first 72 hours after Caesarean section affects around 33% of parturients.

This is a particularly debilitating event for parturients, exposing them to the risk of further urinary catheterization, increased theoretical risk of urinary tract infection, traumatic urethral injury, hindered accelerated rehabilitation and altered maternal satisfaction.

Several studies have demonstrated the benefits of adding magnesium sulfate to epidural anesthesia for Caesarean sections, notably by reducing postoperative pain.

Magnesium sulfate may also have a facilitating effect on postoperative micturition, thanks to its sympathicolytic effect.

This hypothesis is supported by a retrospective study carried out in our maternity hospital, which showed a 15% reduction in post-Caesarean urinary retention when women were given magnesium sulfate in addition to the drugs traditionally used for epidurals.

This little-known property needs to be clarified

Publications & conference data

No peer-reviewed publications indexed yet for this trial.