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Two common drugs face off to shield mothers from a dangerous drop in blood pressure

NCT ID NCT07793760

Prevention Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This trial compares two drugs, dexamethasone and ondansetron, given before spinal anesthesia for cesarean delivery in women with preeclampsia. Spinal anesthesia often causes a sudden drop in blood pressure, which can reduce blood flow to the placenta and vital organs. Researchers will randomly assign 110 women to receive one of the two drugs and monitor blood pressure, heart rate, and outcomes for both mother and baby. The goal is to see which drug better prevents this dangerous complication.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Intravenous dexamethasone (8 mg) or intravenous ondansetron (4 mg), given 15 minutes before spinal anesthesia
What this could lead to
If one drug works better, it could offer a simple, safe way to prevent blood pressure drops during cesarean delivery in women with preeclampsia, protecting both mother and baby.
What could go wrong
This is a single-center trial with 110 participants, so results may not apply broadly. The drugs may not prevent hypotension effectively, and each carries its own side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Oct 2026

An estimate. Start dates often move.

Expected to finish

Nov 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 40 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

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Conditions

The condition(s) this trial relates to.

preeclampsia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cesarean section Preeclampsia Spinal anesthesia-induced hypotension

How to take part

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  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

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