PreeclampsiaPhase 4NCT07793760
Dexamethasone Versus Ondansetron for Preventing Post-Spinal Hypotension in Preeclampsia
A Phase 4 study testing Dexamethasone and Ondansetron in people with Preeclampsia and Spinal Anesthesia-Induced Hypotension, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Preeclampsia, Spinal Anesthesia-Induced Hypotension, Cesarean Section
- What is being tested?
- Dexamethasone and Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Nov 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Peripartum bleeding.
- Obesity (body mass index ≥40 kg/m²).
- Coagulation disorders (platelet count < 75,000/μL).
- Neurological disorders.
- Previous or current systemic corticosteroid therapy.
- Known cardiac disease.
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- History of diabetes mellitus.
- Renal dysfunction (serum creatinine > 2 mg/dL).
- Hepatic dysfunction (serum liver enzymes > 2 times the upper limit of normal).
- Known hypersensitivity to dexamethasone, ondansetron, or any component of the study medications.
- Emergency cesarean delivery.
- Known fetal congenital anomalies.
About this study
Official title: Intravenous Dexamethasone Versus Ondansetron in the Prevention of Post-Spinal Hypotension in Preeclampsia Patients Undergoing Caesarean Delivery: A Prospective Randomized Clinical Trial
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.
- Being tested
- Dexamethasone, Ondansetron
- Keywords
- Dexamethasone, Ondansetron, Post-Spinal Hypotension, Preeclampsia, Spinal Anesthesia, Cesarean Delivery, Optic Nerve Sheath Diameter, Vasopressors
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexamethasoneDrug
Intravenous dexamethasone 8 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anesthesia.
OndansetronDrug
Intravenous ondansetron 4 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Group D: Dexamethasone | Experimental | Patients in Group D will receive intravenous dexamethasone 8 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anaesthesia. Receives: Drug: Dexamethasone |
| Group O: Ondansetron | Active comparator | Patients in Group O will receive intravenous ondansetron 4 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anaesthesia. Receives: Drug: Ondansetron |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of post-spinal hypotension
Number of participants with a decrease in systolic blood pressure below 80% of baseline.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Amin Abdelhamid Aboughadir, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793760
- Sponsor's protocol ID
- Dex vs Ondan: Spinal BP in PE
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2026
- Last updated
- 31 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexamethasone Versus Ondansetron in the Prevention of Post-Spinal Hypotension in Preeclampsia Patients Undergoing Caesarean Delivery: A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07793760
- Acronym / sponsor ID
- Dex vs Ondan: Spinal BP in PE
- Keywords
- Dexamethasone, Ondansetron, Post-Spinal Hypotension, Preeclampsia, Spinal Anesthesia, Cesarean Delivery, Optic Nerve Sheath Diameter, Vasopressors
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 31 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D: Dexamethasone | Experimental | Drug: DexamethasonePatients in Group D will receive intravenous dexamethasone 8 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anaesthesia. |
| Group O: Ondansetron | Active comparator | Drug: OndansetronPatients in Group O will receive intravenous ondansetron 4 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anaesthesia. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (12 listed)
- Peripartum bleeding.
- Obesity (body mass index ≥40 kg/m²).
- Coagulation disorders (platelet count < 75,000/μL).
- Neurological disorders.
- Previous or current systemic corticosteroid therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexamethasoneIntravenous dexamethasone 8 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anesthesia. | Drug | Group D: Dexamethasone |
| OndansetronIntravenous ondansetron 4 mg diluted with 0.9% normal saline to a total volume of 10 mL, administered slowly over approximately one minute, 15 minutes before the induction of spinal anesthesia. | Drug | Group O: Ondansetron |
Primary outcome
Incidence of post-spinal hypotension
Time frame: 1 hour
Number of participants with a decrease in systolic blood pressure below 80% of baseline.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexamethasone and Ondansetron in people with Preeclampsia and Spinal Anesthesia-Induced Hypotension, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of post-spinal hypotension (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.