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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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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
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 groups in NCT07324512
Study groupRoleWhat they receive
Crystalloid Co-LoadingExperimentalParticipants 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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. 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

  11. 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)

  12. 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)

  13. 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

  14. 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

  15. 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.

  1. First posted7 Jan 2026
  2. Study start27 Dec 2025 (estimated)
  3. Primary completion31 May 2026 (estimated)
  4. Study completion30 Jun 2026 (estimated)

Resources

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)
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

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.

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