Hypotension During Cesarean DeliveryPhase 4NCT07615595

Dexamethasone to Prevent Side Effects of Spinal Anesthesia in Cesarean Delivery

A Phase 4 study testing Dexamethasone in people with Hypotension During Cesarean Delivery and Postoperative Nausea and Vomiting (PONV), run by University Medical Center Ho Chi Minh City (UMC) at 1 site in Vietnam.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts

Official record

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Trial summary

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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Hypotension During Cesarean Delivery, Postoperative Nausea and Vomiting (PONV), Pain, Postoperative
What is being tested?: Dexamethasone
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 176 participants
Where: 1 siteVietnam
Study dates: 1 Aug 2025to 31 Jul 2027
Phase: Phase 4

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 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Age ≥ 18 years
Singleton pregnancy
Gestational age ≥ 37 weeks
American Society of Anesthesiologists (ASA) physical status classification of II-III
Planned for elective cesarean delivery under spinal anesthesia

Who cannot join

Gestational diabetes mellitus or pre-existing (chronic) diabetes mellitus
Gestational hypertension or chronic hypertension
Body mass index (BMI) ≥ 35 kg/m²
Known allergy to dexamethasone
Current long-term corticosteroid therapy
Diagnosis of postpartum hemorrhage

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Vietnam1 site

University Medical Center Ho Chi Minh City (UMC) - Campus 2
Ho Chi Minh City, Ho Chi Minh, 700000

Other trials in Vietnam

About this study

Official title: Evaluation of the Effectiveness of Intravenous Dexamethasone in Preventing Adverse Effects of Spinal Anesthesia in Parturients Undergoing 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.

Conditions: Hypotension During Cesarean Delivery, Postoperative Nausea and Vomiting (PONV), Pain, Postoperative
Being tested: Dexamethasone, Placebo
Keywords: Dexamethasone, Prophylaxis, Elective Cesarean Delivery, Spinal-induced Hypotension, Postoperative Analgesia, Parturients
Medical subject headings: Postoperative Nausea and Vomiting, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DexamethasoneDrug
Intravenous administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia.
PlaceboOther
Intravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia.

Study groups in NCT07615595
Study group	Role	What they receive
Dexamethasone	Experimental	Not described Receives: Drug: Dexamethasone
Placebo	Placebo comparator	Not described Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: From the induction of spinal anesthesia until the completion of surgery

Secondary outcomes (2)

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.
Measured: 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).
Measured: From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Aug 202531 Jul 2027

First posted29 May 2026
Study start1 Aug 2025
Primary completion31 Jul 2027 (estimated)
Study completion31 Jul 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Hypotension During Cesarean DeliveryStudies of the same condition, open and under way.
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
Model description: Prospective, randomized, placebo-controlled, single-blind, parallel-group clinical trial
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 176 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07615595
Sponsor's protocol ID: 4667/UMP-BOARD
Status last verified: Nov 2025
First submitted: 22 May 2026
Last updated: 29 May 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Comparison of HPI-guided Norepinephrine Boluses, ClearSight-guided Norepinephrine Infusion, and Oscillometric-guided Norepinephrine Infusion for Blood Pressure Stability During Cesarean Delivery
Hypotension During Cesarean Delivery, Blood Pressure Monitoring
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Comparison of the Efficacy of Continuous Metaraminol Infusion Versus Continuous Norepinephrine Infusion for the Prevention of Hypotension During Cesarean Section Under Spinal Anaesthesia. A Randomised Controlled Trial.
Hypotension After Spinal Anesthesia, Hypotension During Cesarean Delivery

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