A Phase 4 interventional study of Dexamethasone and Placebo in Hypotension During Cesarean Delivery, Postoperative Nausea and Vomiting (PONV) and Pain, Postoperative, sponsored by University Medical Center Ho Chi Minh City (UMC). Enrolling by invitation at 1 site in Vietnam. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-29.
Sponsored by University Medical Center Ho Chi Minh City (UMC) · Phase 4, Interventional, and Prevention
The goal of this clinical trial is to evaluate the effectiveness of intravenous dexamethasone in preventing adverse effects of spinal anesthesia and prolonging postoperative analgesia in parturients undergoing elective cesarean delivery.
The main questions it aims to answer are:
Does intravenous dexamethasone reduce the incidence of post-spinal hypotension?
Does intravenous dexamethasone reduce the incidence of postoperative nausea and vomiting (PONV)?
Does intravenous dexamethasone prolong the duration of postoperative analgesia?
Researchers will compare intravenous dexamethasone (8 mg) to a placebo (0.9% saline) to see if dexamethasone effectively prevents post-spinal hypotension and PONV, and improves postoperative pain relief.
Participants will:
Receive an intravenous injection of either 8 mg dexamethasone or a placebo (2 mL 0.9% saline) prior to receiving spinal anesthesia.
Have their blood pressure recorded frequently (every minute for the first 20 minutes, then every 5 minutes until the completion of surgery).
Undergo sensory block assessment (via cold testing) and motor block evaluation (using the Bromage scale).
Have maternal glycemia and neonatal safety monitored for potential steroid-related adverse effects.
638 studies on the registry are indexed under Postoperative Nausea and Vomiting; 110 are open to participants now.
This study's planned enrollment of 176 is above the median of 112 across 529 interventional studies indexed under Postoperative Nausea and Vomiting.
Browse Postoperative Nausea and Vomiting studies →University Medical Center Ho Chi Minh City (UMC) is the lead sponsor of 34 studies on the registry; 19 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: Dexamethasone
Other: Placebo
Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia.
Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia.
Incidence of Post-Spinal Hypotension
The number of participants experiencing at least one episode of post-spinal hypotension. Hypotension is defined as a decrease in systolic blood pressure of 20% or more from the baseline value. Baseline blood pressure is defined as the mean value of three consecutive measurements taken 2 minutes apart, with a variation of less than 10%. Systolic blood pressure, diastolic blood pressure, mean arterial pressure, and heart rate are recorded every minute for the first 20 minutes after spinal anesthesia, and then every 5 minutes until the completion of surgery and transfer to the post-anesthesia care unit
Time frame: From the induction of spinal anesthesia until the completion of surgery
Incidence of Postoperative Nausea and Vomiting (PONV)
The number of participants experiencing nausea, vomiting, or retching, or requiring rescue antiemetic treatment. Rescue treatment is administered as intravenous ondansetron 4 mg or intravenous metoclopramide 10 mg.
Time frame: From the induction of spinal anesthesia until discharge from the post-anesthesia care unit (PACU) (estimated up to 6 hours)
Duration of Postoperative Analgesia
The time elapsed from the administration of spinal anesthesia to the patient's first request for systemic rescue analgesic medication. Rescue analgesia is administered when the patient complains of pain and records a Visual Analog Scale (VAS) score greater than 4 (on a scale of 0 to 10).
Time frame: From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)
Started Aug 2025 (actual). Primary completion is estimated for Jul 2027, 23 months after the start.
Of 67 non-industry phase 4 interventional studies under Postoperative Nausea and Vomiting, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 23. This study's planned 23 months is above that.
Counting every sponsor, half of 67 studies reached it within 11 months; a quarter within 5 and three quarters within 23.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Dexamethasone
Postoperative Nausea and Vomiting →
University Medical Center Ho Chi Minh City (UMC)