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Tests treatment safety and results for Urinary Retention
Official title 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.
ClinicalTrials.gov ID: NCT06442995
What this study is testing
What is Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space?
Injection of 500 mg magnesium sulfate + 2 mg morphine into the epidural space is an investigational medicine, given as an once-daily injectable medicine, being studied as a potential treatment for urinary retention.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Patients who have undergone scheduled or emergency Caesarean section surgery under extended epidural anesthesia or combined epidural and spinal...
- Patients who have just undergone caesarean section and have the epidural catheter in place in the post-treatment 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
You likely can't join if
- 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
See the full eligibility 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-treatment 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Reims, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Reims, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.