Spinal Induced Hypotension in Cesarean DeliveryNCT07324512
Minimum Effective Volume of Crystalloid Co-Loading to Prevent Spinal Anesthesia-Induced Hypotension in Cesarean Section
A study testing Intravenous Crystalloid Co-Loading in people with Spinal Induced Hypotension in Cesarean Delivery, run by Seoul National University Hospital.
Trial summary
The goal of this clinical trial is to find the minimum effective volume of IV crystalloid that should be given with phenylephrine to prevent hypotension caused by spinal anesthesia in healthy, term pregnant adults having elective cesarean delivery. Read more about this study
- Who is it for?
- Ages 19 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spinal Induced Hypotension in Cesarean Delivery
- What is being tested?
- Intravenous Crystalloid Co-Loading
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 27 Dec 2025to 30 Jun 2026
- Phase
- Interventional
- 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 19 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant adults ≥19 years scheduled for elective cesarean delivery under spinal anesthesia
- Term pregnancy (≥37 weeks' gestation)
Who cannot join
- Emergency cesarean delivery
- Hypertensive disorders of pregnancy (preeclampsia/eclampsia) or hypertension
- Multiple gestation
- Body weight <50 kg or BMI >35 kg/m²
- Renal impairment or eGFR ≤90 mL/min/1.73 m²
- Heart failure or other heart disease
- History of bronchial asthma or other pulmonary disease
About this study
Official title: Determination of the Minimum Effective Volume of Crystalloid Co-Loading for Preventing Spinal Anesthesia-Induced Hypotension in Cesarean Section: A Biased Coin Design Study
The goal of this clinical trial is to find the minimum effective volume of IV crystalloid that should be given with phenylephrine to prevent hypotension caused by spinal anesthesia in healthy, term pregnant adults having elective cesarean delivery.
The main questions are:
Read more
What is the minimum effective volume (MEV90, mL/kg) of crystalloid co-loading that prevents spinal-anesthesia-induced hypotension in ≥90% of participants?
What maternal side effects and newborn outcomes occur with this strategy (e.g., nausea/vomiting, need for extra vasopressors, total fluids/blood loss, Apgar scores, and umbilical cord blood gases)?
There is no separate comparison group; this is a single-arm, adaptive dose-finding study.
Participants will:
Receive a predefined volume of IV crystalloid over ~10 minutes during spinal anesthesia while phenylephrine is infused. Have blood pressure and symptoms monitored; receive rescue treatment if needed. Allow the next participant's fluid volume to be adjusted based on whether hypotension occurred (biased-coin design). Be followed through postoperative day 2 for maternal and newborn outcomes.
- Being tested
- Intravenous Crystalloid Co-Loading
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Crystalloid Co-LoadingOther
Balanced crystalloid is infused intravenously immediately after intrathecal injection as a co-load. A predefined volume (mL/kg) is administered over ~10 minutes. The volume for successive participants is adapted by a biased-coin up-and-down algorithm to estimate the minimum effective volume (MEV90) that prevents spinal-anesthesia-induced hypotension. Rescue fluids are allowed per protocol.
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid Co-Loading | Experimental | Participants undergo spinal anesthesia for elective cesarean delivery. Immediately after intrathecal injection, a predefined volume of balanced crystalloid (co-loading) is infused over ~10 minutes while a prophylactic phenylephrine infusion is initiated per protocol. The crystalloid volume for each successive participant is adjusted using a biased-coin up-and-down algorithm to identify the minimum effective volume that prevents spinal-anesthesia-induced hypotension in ≥90% of patients (MEV90, mL/kg). Blood pressure is monitored frequently; rescue phenylephrine and/or fluids are permitted to maintain predefined blood pressure ranges. Maternal adverse events and neonatal outcomes are recorded through postoperative day 2. Receives: Other: Intravenous Crystalloid Co-Loading |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimum Effective Volume (MEV90) of Intravenous Crystalloid Co-Loading (mL/kg)
The smallest crystalloid co-loading dose (mL/kg) that prevents spinal-anesthesia-induced hypotension in ≥90% of participants when given with prophylactic phenylephrine.
Measured: From intrathecal injection (start of spinal anesthesia) to end of surgery
Secondary outcomes (15)
Incidence of intraoperative hypotension (mmHg)
Hypotension is defined as a drop in systolic blood pressure (SBP) to < 80% of the participant's baseline SBP (mmHg). Baseline SBP is the mean of the last three ward SBP measurements obtained before operating room admission.
Measured: From intrathecal injection to end of surgery
Incidence of intraoperative hypertension (mmHg)
Hypertension is defined as any occurrence of systolic blood pressure (SBP) > 120% of baseline SBP (mmHg) after spinal anesthesia. Baseline SBP is the mean of the last three ward SBP measurements obtained before operating room admission.
Measured: From intrathecal injection to end of surgery
Additional bolus phenylephrine requirement
Administration of rescue phenylephrine bolus in addition to the protocolized prophylactic phenylephrine infusion to treat or prevent hypotension after spinal anesthesia. Hypotension is defined as SBP < 80% of baseline SBP (mmHg) or MAP < 65 mmHg. Baseline SBP is the mean of the last three ward SBP measurements obtained before operating room admission. When hypotension occurs, phenylephrine 100 µg is administered as an IV bolus to restore blood pressure. The outcome is recorded as number of phenylephrine boluses.
Measured: From intrathecal injection to end of surgery
Total Phenylephrine Dose (µg)
Total intraoperative phenylephrine dose administered after spinal anesthesia, defined as the sum of the prophylactic infusion dose and all rescue bolus doses. he prophylactic infusion starts at 1,500 µg/h and the infusion rate is reduced if systolic blood pressure (SBP) exceeds 120% of baseline SBP (mmHg). Baseline SBP is the mean of the last three ward SBP measurements obtained before operating room admission. Rescue bolus protocol: phenylephrine 100 µg IV per hypotensive episode (SBP < 80% of baseline SBP [mmHg] or MAP < 65 mmHg), repeated as needed. Dose will be abstracted from the anesthesia record (infusion rate × time plus boluses) and summarized in micrograms (µg).
Measured: From intrathecal injection to end of surgery
Estimated blood loss (mL)
Calculated as (suction canister volume - irrigation volume) + gravimetric estimate of soaked sponges/drapes (1 g ≈ 1 mL). For cesarean delivery, amniotic fluid is excluded.
Measured: From skin incision to end of surgery
Incidence of Maternal Nausea Associated With Hypotension
Occurrence of nausea temporally associated with hypotension after spinal anesthesia. Recorded as yes/no (≥1 episode) and number of episodes.
Measured: From intrathecal injection to end of surgery
Incidence of Maternal Vomiting Associated With Hypotension
Occurrence of vomiting temporally associated with hypotension after spinal anesthesia. Recorded as yes/no (≥1 episode) and number of emetic events.
Measured: From intrathecal injection to end of surgery
Incidence of Maternal Dizziness/Lightheadedness Associated With Hypotension
Occurrence of dizziness/lightheadedness temporally associated with hypotension after spinal anesthesia. Recorded as yes/no (≥1 episode) and number of episodes.
Measured: From intrathecal injection to end of surgery
Neonatal Apgar score at 1Minute
The Apgar score (range 0-10) assessed 1 minute after birth by clinical staff according to standard practice. It is the sum (0-2 each) of heart rate, respiratory effort, muscle tone, reflex irritability, and skin color. Recorded as the total score (0-10) and, if available, the five component scores.
Measured: At 1 minute after birth
Neonatal Apgar Score at 5 Minutes
The Apgar score (range 0-10) assessed 5 minutes after birth by clinical staff according to standard practice. It is the sum (0-2 each) of heart rate, respiratory effort, muscle tone, reflex irritability, and skin color. Recorded as the total score (0-10) and, if available, the five component scores.
Measured: At 5 minutes after birth
Umbilical Arterial pH
Umbilical cord arterial blood gas pH obtained immediately after birth from a double-clamped cord segment and analyzed per routine laboratory practice.
Measured: At delivery (immediately after birth)
Umbilical Arterial Base Excess (mmol/L)
Umbilical cord arterial blood gas base excess measured immediately after birth from a double-clamped cord segment, processed per routine laboratory practice.
Measured: At delivery (immediately after birth)
Pulmonary edema
New-onset pulmonary edema within 48 hours after surgery, defined by physician diagnosis supported by clinical findings (e.g., dyspnea, crackles) and/or objective evidence (e.g., new supplemental oxygen requirement or SpO₂ ≤ 92% on room air, chest imaging consistent with interstitial/alveolar edema). Record as yes/no (≥1 event).
Measured: Through postoperative day 2
Clinically Significant Generalized Edema
Generalized pitting edema present within 48 hours after surgery, defined by ≥1 of the following objective criteria (excluding localized, surgical-site-limited edema):
(A) Physical exam: pitting grade ≥2+ in ≥2 anatomic regions (e.g., bilateral pretibial/ankle, hands/forearms, sacral, or periorbital), using the standard indentation scale - 2+: ~4 mm pit, brief rebound; 3+: ~6 mm pit, 10-60 s rebound; 4+: ~8 mm pit, >60 s rebound.
(B) Anthropometry: body weight increase ≥2% (or ≥2 kg) from the preoperative baseline or bilateral mid-calf circumference increase ≥2 cm from baseline.
(C) Therapeutic criterion: initiation or escalation of diuretic therapy (e.g., IV/PO loop diuretic) for generalized edema as judged by the treating clinician.
Recorded as yes/no (≥1 criterion met)
Measured: Through postoperative day 2
Acute Heart Failure
New diagnosis of acute heart failure within 48 hours after surgery, characterized by symptoms/signs (e.g., dyspnea, orthopnea, pulmonary congestion), objective evidence (e.g., chest radiographic congestion, elevated BNP/NT-proBNP if available, or echocardiographic findings), and requirement for treatment (e.g., IV diuretics, vasodilators, inotropes, or noninvasive ventilation). Record as yes/no (≥1 event).
Measured: Through postoperative day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start27 Dec 2025 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Induced Hypotension in Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07324512
- Sponsor's protocol ID
- 2508-038-1665
- Status last verified
- Oct 2025
- First submitted
- 14 Dec 2025
- Last updated
- 7 Jan 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 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Minimum Effective Volume of Crystalloid Co-Loading for Preventing Spinal Anesthesia-Induced Hypotension in Cesarean Section: A Biased Coin Design Study
- ClinicalTrials.gov ID
- NCT07324512
- Acronym / sponsor ID
- 2508-038-1665
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 27 Dec 2025 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 7 Jan 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 find the minimum effective volume of IV crystalloid that should be given with phenylephrine to prevent hypotension caused by spinal anesthesia in healthy, term pregnant adults having elective cesarean delivery.
The main questions are:
What is the minimum effective volume (MEV90, mL/kg) of crystalloid co-loading that prevents spinal-anesthesia-induced hypotension in ≥90% of participants?
What maternal side effects and newborn outcomes occur with this strategy (e.g., nausea/vomiting, need for extra vasopressors, total fluids/blood loss, Apgar scores, and umbilical cord blood gases)?
There is no separate comparison group; this is a single-arm, adaptive dose-finding study.
Participants will:
Receive a predefined volume of IV crystalloid over ~10 minutes during spinal anesthesia while phenylephrine is infused. Have blood pressure and symptoms monitored; receive rescue treatment if needed. Allow the next participant's fluid volume to be adjusted based on whether hypotension occurred (biased-coin design). Be followed through postoperative day 2 for maternal and newborn outcomes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crystalloid Co-Loading | Experimental | Other: Intravenous Crystalloid Co-LoadingParticipants undergo spinal anesthesia for elective cesarean delivery. Immediately after intrathecal injection, a predefined volume of balanced crystalloid (co-loading) is infused over ~10 minutes while a prophylactic phenylephrine infusion is initiated per protocol. The crystalloid volume for each successive participant is adjusted using a biased-coin up-and-down algorithm to identify the minimum effective volume that prevents spinal-anesthesia-induced hypotension in ≥90% of patients (MEV90, mL/kg). Blood pressure is monitored frequently; rescue phenylephrine and/or fluids are permitted to maintain predefined blood pressure ranges. Maternal adverse events and neonatal outcomes are recorded through postoperative day 2. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant adults ≥19 years scheduled for elective cesarean delivery under spinal anesthesia
- Term pregnancy (≥37 weeks' gestation)
Key exclusion criteria (7 listed)
- Emergency cesarean delivery
- Hypertensive disorders of pregnancy (preeclampsia/eclampsia) or hypertension
- Multiple gestation
- Body weight <50 kg or BMI >35 kg/m²
- Renal impairment or eGFR ≤90 mL/min/1.73 m²
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 |
|---|---|---|
| Intravenous Crystalloid Co-LoadingBalanced crystalloid is infused intravenously immediately after intrathecal injection as a co-load. A predefined volume (mL/kg) is administered over ~10 minutes. The volume for successive participants is adapted by a biased-coin up-and-down algorithm to estimate the minimum effective volume (MEV90) that prevents spinal-anesthesia-induced hypotension. Rescue fluids are allowed per protocol. | Other | Crystalloid Co-Loading |
Primary outcome
Minimum Effective Volume (MEV90) of Intravenous Crystalloid Co-Loading (mL/kg)
Time frame: From intrathecal injection (start of spinal anesthesia) to end of surgery
The smallest crystalloid co-loading dose (mL/kg) that prevents spinal-anesthesia-induced hypotension in ≥90% of participants when given with prophylactic phenylephrine.
15 secondary outcomes
Incidence of intraoperative hypotension (mmHg)
Time frame: From intrathecal injection to end of surgery
Incidence of intraoperative hypertension (mmHg)
Time frame: From intrathecal injection to end of surgery
Additional bolus phenylephrine requirement
Time frame: From intrathecal injection to end of surgery
Total Phenylephrine Dose (µg)
Time frame: From intrathecal injection to end of surgery
Estimated blood loss (mL)
Time frame: From skin incision to end of surgery
Incidence of Maternal Nausea Associated With Hypotension
Time frame: From intrathecal injection to end of surgery
Incidence of Maternal Vomiting Associated With Hypotension
Time frame: From intrathecal injection to end of surgery
Incidence of Maternal Dizziness/Lightheadedness Associated With Hypotension
Time frame: From intrathecal injection to end of surgery
Neonatal Apgar score at 1Minute
Time frame: At 1 minute after birth
Neonatal Apgar Score at 5 Minutes
Time frame: At 5 minutes after birth
Umbilical Arterial pH
Time frame: At delivery (immediately after birth)
Umbilical Arterial Base Excess (mmol/L)
Time frame: At delivery (immediately after birth)
Pulmonary edema
Time frame: Through postoperative day 2
Clinically Significant Generalized Edema
Time frame: Through postoperative day 2
Acute Heart Failure
Time frame: Through postoperative day 2
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 7 Jan 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 study testing Intravenous Crystalloid Co-Loading in people with Spinal Induced Hypotension in Cesarean Delivery, run by Seoul National University Hospital.
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 2 inclusion and 7 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 7 Jan 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.
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?
Minimum Effective Volume (MEV90) of Intravenous Crystalloid Co-Loading (mL/kg) (time frame: From intrathecal injection (start of spinal anesthesia) to end 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 7 Jan 2026.