Adding magnesium sulfate to morphine to reduce urinary retention after cesarean section
Superiority Randomized Double-blind Controlled Trial of Epidural Magnesium Sulfate Addition Versus Placebo on the Occurrence of Acute Post-caesarean Urinary Retention
PHASE4 · CHU de Reims · NCT06442995
This study is testing if adding magnesium sulfate to morphine during epidural anesthesia can help reduce urinary retention in women after a cesarean section.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 290 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | CHU de Reims (other) |
| Locations | 1 site (Reims) |
| Trial ID | NCT06442995 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of adding magnesium sulfate to morphine in the epidural space to decrease the occurrence of acute urinary retention following cesarean sections. The study will involve 290 parturients who will be randomly assigned to receive either magnesium sulfate or a placebo along with morphine during their epidural anesthesia. The primary goal is to determine if this combination can reduce the incidence of urinary retention, which affects about 33% of women after cesarean delivery. Participants will be monitored post-surgery to assess urinary function and any adverse effects.
Who should consider this trial
Good fit: Ideal candidates are adult women undergoing scheduled or emergency cesarean sections with epidural anesthesia at the Reims University Hospital.
Not a fit: Patients who are minors, have severe renal insufficiency, or are undergoing general anesthesia will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce the incidence of urinary retention in postpartum women, improving their recovery experience.
How similar studies have performed: Previous studies have shown promising results with magnesium sulfate in reducing postoperative complications, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients who have undergone scheduled or emergency Caesarean section surgery under extended epidural anesthesia or combined epidural and spinal anesthesia at the Reims University Hospital. * Patients who have just undergone caesarean section and have the epidural catheter in place in the post-interventional monitoring room (SSPI). * Patients who agree to take part in the research and have signed the informed consent form * Patients of legal age * Patients affiliated to a social security scheme Exclusion Criteria: * Minor patients * Patients protected by law * Patients allergic to local anesthetics, morphine or magnesium sulfate * Patients with severe renal insufficiency (GFR \< 30 ml/min) * Patients with pre-pregnancy mictional disorders * Patients with an American Society of Anesthesiologists (ASA) score of 4 * Patients undergoing caesarean section under general anaesthesia, after failure of perimedullary anaesthesia * Patients with accidental intraoperative injury to the urinary tract * Patients who have received intravenous magnesium sulfate in the 24 hours preceding cesarean section
Where this trial is running
Reims
- Chu Reims — Reims, France (RECRUITING)
Study contacts
- Study coordinator: Maxime Riffault
- Email: mriffault@chu-reims.fr
- Phone: 00336 79 63 29 55
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Urinary Retention