NCT07793760Not yet recruitingPhase 4
Dexamethasone Versus Ondansetron for Preventing Post-Spinal Hypotension in Preeclampsia
Intravenous Dexamethasone Versus Ondansetron in the Prevention of Post-Spinal Hypotension in Preeclampsia Patients Undergoing Caesarean Delivery: A Prospective Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 31 Aug 2026
Brief summary (registry, in English)
This study compares the efficacy and safety of intravenous dexamethasone versus intravenous ondansetron in preventing low blood pressure (hypotension) following spinal anesthesia in pregnant women with preeclampsia undergoing scheduled cesarean delivery. Spinal anesthesia is the preferred anesthetic method for cesarean delivery, but it frequently causes a sudden drop in maternal blood pressure. In patients with preeclampsia, post-spinal hypotension can compromise blood flow to the placenta and vital organs. While traditional vasopressor medications are used to restore blood pressure, non-adrenergic prophylactic agents such as dexamethasone and ondansetron may help maintain hemodynamic stability through different physiological pathways. Participants will be randomly assigned to receive either intravenous dexamethasone (8 mg) or intravenous ondansetron (4 mg) 15 minutes prior to the initiation of spinal anesthesia. Blood pressure, heart rate, vasopressor requirements, optic nerve sheath diameter, and maternal and neonatal outcomes will be monitored throughout the surgery and during the immediate postoperative period.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- First submitted
- 26 Aug 2026
- Start date
- Oct 2026
- Primary completion date
- Oct 2027
- Lead sponsor
- Assiut University
- NCT number
- NCT07793760
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 110
- From Oct 2026 to the primary completion date, Oct 2027
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Previous or current systemic corticosteroid therapy.
Other illness
- Peripartum bleeding.
- Neurological disorders.
- Known cardiac disease.
- History of diabetes mellitus.
- Known hypersensitivity to dexamethasone, ondansetron, or any component of the study medications.
Lab values
- Coagulation disorders (platelet count \< 75,000/μL).
- Renal dysfunction (serum creatinine \> 2 mg/dL).
- Hepatic dysfunction (serum liver enzymes \> 2 times the upper limit of normal).
Other
- Obesity (body mass index ≥40 kg/m²).
- Emergency cesarean delivery.
- Known fetal congenital anomalies.
Who the study is looking for
- Pregnant women aged 18 to 40 years.
- American Society of Anesthesiologists (ASA) physical status III.
- Diagnosed with preeclampsia (new onset of hypertension ≥140/90 mmHg with proteinuria occurring after 20 weeks of gestation according to ACOG and ISSHP guidelines).
- Scheduled for elective cesarean delivery under spinal anesthesia.
Age in the registry: 18 years to 40 years · Sex: Female · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.