NCT06442995 Evaluation of the Efficacy of the Addition of Magnesium Sulfate to Morphine on the Occurrence of Acute Urinary Retention Following Epidural Anesthesia for Cesarean Section.
| NCT ID | NCT06442995 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | CHU de Reims |
| Condition | Urinary Retention |
| Study Type | INTERVENTIONAL |
| Enrollment | 290 participants |
| Start Date | 2025-01-16 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 290 participants in total. It began in 2025-01-16 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Eligibility 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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06442995 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Urinary Retention. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06442995 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT06442995 currently recruiting?
Yes, NCT06442995 is actively recruiting participants. Contact the research team at mriffault@chu-reims.fr for enrollment information.
Where is the NCT06442995 trial being conducted?
This trial is being conducted at Reims, France.
Who is sponsoring the NCT06442995 clinical trial?
NCT06442995 is sponsored by CHU de Reims. The trial plans to enroll 290 participants.