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.
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
- 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 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
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 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:
Read more
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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of Intravenous Dexamethasone in Preventing Adverse Effects of Spinal Anesthesia in Parturients Undergoing Cesarean Delivery
- ClinicalTrials.gov ID
- NCT07615595
- Acronym / sponsor ID
- 4667/UMP-BOARD
- Conditions
- Hypotension During Cesarean Delivery, Postoperative Nausea and Vomiting (PONV), Pain, Postoperative
- Keywords
- Dexamethasone, Prophylaxis, Elective Cesarean Delivery, Spinal-induced Hypotension, Postoperative Analgesia, Parturients
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 176 participants (estimated)
- Lead sponsor
- University Medical Center Ho Chi Minh City (UMC)University, hospital or other
- Study start
- 1 Aug 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 29 May 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, randomized, placebo-controlled, single-blind, parallel-group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Dexamethasone | Experimental | Drug: Dexamethasone |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
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 administration of 8 mg dexamethasone immediately before the induction of spinal anesthesia. | Drug | Dexamethasone |
| PlaceboIntravenous administration of 2 mL of 0.9% normal saline as a placebo immediately before the induction of spinal anesthesia. | Other | Placebo |
Primary outcome
Incidence of Post-Spinal Hypotension
Time frame: From the induction of spinal anesthesia until the completion of surgery
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
2 secondary outcomes
Incidence of Postoperative Nausea and Vomiting (PONV)
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
Time frame: From the administration of spinal anesthesia until the first request for rescue analgesia (estimated up to 24 hours)
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 29 May 2026.
Related trials for Hypotension During Cesarean Delivery
Not yet recruiting
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
Not yet recruiting
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
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
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 5 inclusion and 6 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: enrolling by invitation, as of the sponsor's last update on 29 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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: From the induction of spinal anesthesia until the completion of surgery). 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 29 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.