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Completed

NCT Number: NCT05435573

Cardiac Output in Preeclamptic

There is high incidence of hypertensive disorders during pregnancy.The maternal cardiovascular system had significant changes during pregnancy. The colloid oncotic pressure is decreased during preeclampsia.

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Key information

Conditions

Echocardiography

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Mansoura University-Emergency hospital-ICU

Al Mansurah, Mansoura, 35511, Egypt

About this study

Transthoracic echocardiography considered an accurate non-invasive device and has validity for measuring cardiac functions in pregnancy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pre-eclampsia
  • Age 18-45 years.
  • Singleton pregnancy scheduled for elective CS delivery under spinal anesthesia.
  • American Society of Anesthesiologists (ASA Ⅱ, Ⅲ).

Exclusion criteria

  • Body mass index < 18 or ≥40 kg/m²
  • Women presenting in labor
  • Current administration of vasoactive drugs including salbutamol and thyroxin.
  • Diabetes mellitus.
  • Hemoglobin <10 g/dl.
  • Cardiovascular, cerebrovascular, or renal disease
  • Increased serum creatinine level ≥1.1 mg/dL.
  • Contraindications to spinal anesthesia:(increased intracranial pressure, coagulopathy, or local skin infection)

Treatment and study plan

1000 mL of ringer's acetate solution

Drug

1000 mL of ringer's acetate solution

250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven)

Drug

500 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride plus 500 mL of ringer's acetate solution

Primary outcomes

  1. Cardiac output measurement

    Time frame: 1 hour from the spinal anesthesia

    1 hour post spinal anesthesia after administration of 1000 mL fluid using Transthoracic Echocardiography

Secondary outcomes

  1. Cardiac output measurement

    Time frame: 5 minutes after the spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia

    at baseline ,5 minutes after spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia

  2. Left ventricular end diastolic volume (LVEDV) measurement

    Time frame: 1 hour from the spinal anesthesia

    milliliter

  3. Urine output volume

    Time frame: 1hour and 2 hours post spinal anesthesia

    milliliters

  4. Heart rate (HR)

    Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

    beats per minute

  5. Mean Blood pressure

    Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours

    mmHg

Sponsors and collaborators

Lead sponsor

Mansoura University

Other

Registry information

Official study title

Coload Effect on Cardiac Output Measurement Using Transthoracic Echocardiography in Preeclamptic Patients Undergoing Cesarean Delivery

Acronym: Coload

Important dates

Study start
2022
Primary completion
2023
Study completion
2024
First posted
Jun 28, 2022
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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