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Effect of Ringer lactate solution and noradrenaline tartrate on cardiac index in non‑fluid responsive term pregnant women undergoing elective caesarean delivery

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

The trial involves women who are in pregnancy at term and are scheduled for an elective caesarean delivery. The investigation compares giving a fluid called crystalloid co-load using a solution known as RINGER LATTATO BAXTER Soluzione per infusione, which contains potassium chloride, sodium chloride, calcium chloride dihydrate, and sodium (s)-lactate 60%, with not giving that fluid. A medication called NORADRENALINE TARTRATE (active ingredient noradrenaline tartrate) may be used if blood pressure drops. The purpose of the study is to find out whether skipping the fluid does not cause a meaningful drop in the heart’s pumping ability measured as cardiac index.

Participants will receive spinal anesthesia for the surgery, and the timing from the injection until umbilical cord clamping will be closely watched. Throughout this period a device called the Edwards ClearSight system will continuously record heart output. Some participants will get the fluid infusion at the start of anesthesia, while others will not, and any need for additional medication to raise blood pressure will be recorded.

The study will also look at changes in a test called the lung ultrasound score, episodes of hypotension defined by a fall in systolic blood pressure, how many doses of a vasopressor and the total amount of norepinephrine are required, as well as the newborn’s Apgar scores and the umbilical arterial blood pH at birth.

The research process

The trial runs in 12 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Check‑in on the day of surgery

    You arrive at the hospital for your scheduled elective caesarean delivery and are registered for the study.

  2. Step 2

    Baseline measurements

    Your blood pressure, heart rate, and a lung ultrasound are recorded before any study procedures begin.

  3. Step 3

    Randomization to study group

    You are randomly assigned to either the crystalloid co‑load group or the no co‑load group. The assignment determines whether you will receive an intravenous fluid infusion during the operation.

  4. Step 4

    Administration of crystalloid co‑load (if assigned)

    If you are in the co‑load group, a 2 L infusion of Ringer lactate solution is started through an IV line at the beginning of the surgery and is given continuously until the baby is delivered.

  5. Step 5

    Spinal anesthesia

    A spinal block is placed to provide anesthesia for the caesarean delivery.

  6. Step 6

    Continuous cardiac monitoring

    A device called ClearSight measures your cardiac index (the amount of blood the heart pumps per minute per square meter of body surface). Measurements begin when the spinal anesthesia is given and continue until the umbilical cord is clamped.

  7. Step 7

    Rescue medication for low blood pressure

    If your systolic blood pressure drops below 90 % of the baseline value, a rescue medication may be administered. This consists of an infusion of noradrenaline tartrate at a dose of 1 mg, given as a bolus and repeated only if needed during the same monitoring period.

  8. Step 8

    Recording of symptoms and interventions

    Any episodes of low blood pressure, the number of rescue medication doses, and any feelings of nausea or vomiting are documented.

  9. Step 9

    End of primary monitoring

    When the umbilical cord is clamped, the continuous monitoring of cardiac index stops and the primary data collection period ends.

  10. Step 10

    Post‑operative lung ultrasound

    A second lung ultrasound is performed after the surgery. The difference between this score and the pre‑operative score is calculated.

  11. Step 11

    Neonatal assessments

    The newborn’s Apgar scores are recorded at 1 minute and 5 minutes after birth, and a blood sample from the umbilical artery is taken to measure pH.

  12. Step 12

    Completion of study participation

    All required measurements are completed and your involvement in the trial ends.

Who can join the trial?

6 criteria

  • Be a woman who is at least 18 years old.
  • Be pregnant and between 36 and 40 weeks of gestation (the weeks of pregnancy).
  • Plan to have an elective caesarian delivery using spinal anesthesia (a medication injected into the back to numb you for surgery).
  • Be able to use the Edwards ClearSight system, a device that provides continuous non‑invasive hemodynamic monitoring (it measures heart and blood pressure without needles) and give reliable measurements before randomization.
  • Be classified as non‑fluid responsive, meaning that after receiving 250 mL of Ringer's lactate (a sterile IV fluid) over 10 minutes, your stroke volume (the amount of blood your heart pumps with each beat) increases by less than 10 %.
  • Be able to understand the study information and be willing to sign a written informed consent form.

Who cannot join the trial?

17 criteria

  • You have a current blood clot in an artery or vein, such as a clot that blocks blood flow to the intestines (mesenteric ischemia) or a severe blockage in a leg (critical limb ischemia).
  • You need an emergency or urgent cesarean delivery (emergent or urgent CD).
  • You have a bleeding disorder that affects how your blood clots (coagulopathy).
  • Spinal anesthesia is not safe for you (contraindications to spinal anesthesia).
  • Your high blood pressure is not under control or you have had dangerous spikes in blood pressure (uncontrolled chronic arterial hypertension or hypertensive crises).
  • You have heart disease caused by reduced blood flow, such as unstable chest pain (unstable angina) or a past heart attack (myocardial infarction).
  • You have irregular heartbeats that cause symptoms or are not controlled, especially fast or dangerous rhythms from the lower chambers of the heart (ventricular arrhythmias or tachyarrhythmias).
  • You have a serious heart condition that changes the heart’s structure, such as faulty heart valves that affect blood flow (hemodynamically significant valvular heart disease) or a weakened heart muscle (cardiomyopathy).
  • You have a severe lung disease that makes it hard for you to breathe properly (clinically relevant respiratory impairment).
  • You have untreated hormone problems, such as an overactive thyroid (hyperthyroidism) or a rare tumor that produces excess hormones (pheochromocytoma).
  • You have taken a medication called a monoamine oxidase inhibitor (MAOI) within the past two weeks.
  • You are allergic to norepinephrine (a medication) or any of the inactive ingredients in its formulation.
  • You have advanced disease of the blood vessels in your arms or legs that could cause sudden narrowing (vasospasm) or lack of blood flow to tissue (tissue ischemia).
  • You do not have a dependable IV line that can be used for a continuous medication drip (reliable intravenous access).
  • You have an unstable brain or metabolic condition that makes drugs that increase sympathetic activity unsafe (sympathomimetic agents).
  • You are already taking part in another research study.
  • You have severe pregnancy complications such as preeclampsia, eclampsia, or HELLP syndrome.
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Investigated drugs

  • Ringer Lactato Baxter

    is an intravenous fluid that contains a balanced mix of salts such as potassium, sodium, calcium, and lactate. It is given through a drip into a vein to help keep the body’s fluid and electrolyte levels stable during surgery. In this study, it was used as a “co‑load,” meaning it was given at the same time as the spinal anesthesia to see if it affects the heart’s blood‑flow measurements.

  • Noradrenaline Tartrate

    is a medication that is infused into a vein to raise blood pressure. It works by tightening the small blood vessels, which helps improve blood flow to vital organs. In the trial, it was used to support blood pressure when needed during the cesarean delivery, allowing researchers to compare its effect with the fluid treatment.

What is already known about the treatment

  • Ringer's Lactate Solution

    This medication is given as an intravenous infusion, meaning it is poured into a vein through a drip. It is a well‑known, widely used fluid that appears in many hospital formularies and medical textbooks. It is mainly used to replace lost fluids and electrolytes during surgery, dehydration, or when electrolyte balance needs correction. The solution contains sodium, potassium, calcium and lactate, which together help keep blood volume stable and support normal acid‑base balance, and it is classified as an isotonic crystalloid electrolyte solution.

  • Norepinephrine Tartrate

    This drug is administered by intravenous infusion, typically as a controlled drip into a vein. It is an established medication in critical‑care practice and is extensively described in medical literature. It is primarily used to raise blood pressure in patients with severe low‑pressure states such as shock. It works by stimulating receptors on blood‑vessel walls, causing the vessels to tighten and lift the pressure, and it belongs to the vasopressor (sympathomimetic) drug class.

Investigated diseases

Term pregnancy - Term pregnancy is a stage of gestation when the fetus has reached 37 to 42 weeks of development. At this point, the baby has completed most of its growth and organ maturation. The uterus enlarges and the cervix may begin to soften in preparation for labor. Hormonal signals increase, leading to regular uterine contractions that may start spontaneously. If labor does not start naturally, medical induction may be considered.
Trial detailsLast updated 11 Nov 2026
Age18+ yearsPhasePhase IIITrial ID2026-525402-35-00Protocol codeCO-LOAD/C-SECTIONEstimated enrolment40 patientsSponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS

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