NCT06248593 Continuous Infusion of Norepinephrine vs Phenylephrine During Spinal Anesthesia for Cesarean Section (INPEACE)
| NCT ID | NCT06248593 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hassan II University |
| Condition | Cesarean Section Complications |
| Study Type | INTERVENTIONAL |
| Enrollment | 140 participants |
| Start Date | 2025-01-29 |
| Primary Completion | 2026-03-15 |
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 140 participants in total. It began in 2025-01-29 with a primary completion date of 2026-03-15.
⚠ 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
The goal of this clinical trial is to compare norepinephrine and ephedrine in maintaining blood pressure during spinal anaesthesia for elective cesarean delivery. The main questions it aims to answer are: * Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on neonatal outcome ? * Do phenylephrine and norepinephrine administered as manually controlled continuous infusion during elective cesarean delivery have different effects on maternal hemodynamics? Participants will receive either phenylephrine or norepinephrine infusion, at the time of performing spinal anesthesia, the infusion rate will be adjusted manually depending on maternal arterial pressure.
Eligibility Criteria
Inclusion Criteria: * Full-term, singleton, pregnant women, nonlaboring. * Scheduled for elective cesarean delivery under spinal anesthesia, * American Society of Anesthesiologists physical status : 1 or 2 * Baseline systolic BP between 90 and 140 mm Hg. Exclusion Criteria: * Known fetal abnormality. * Preexisting or pregnancy-induced hypertension, cardiovascular, cerebrovascular or kidney disease. * Contraindication to spinal anesthesia. * Peripartum hemorrhage. * Body mass index above 40 kg/m2.
Contact & Investigator
Mohamed Adnane Berdai, MD-PhD
PRINCIPAL INVESTIGATOR
University hospital Hassan II, Fes, Morocco
Frequently Asked Questions
Who can join the NCT06248593 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Cesarean Section Complications. 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 NCT06248593 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 NCT06248593 currently recruiting?
Yes, NCT06248593 is actively recruiting participants. Contact the research team at adnane.berdai@yahoo.fr for enrollment information.
Where is the NCT06248593 trial being conducted?
This trial is being conducted at Fes, Morocco, Fes, Morocco.
Who is sponsoring the NCT06248593 clinical trial?
NCT06248593 is sponsored by Hassan II University. The principal investigator is Mohamed Adnane Berdai, MD-PhD at University hospital Hassan II, Fes, Morocco. The trial plans to enroll 140 participants.