EchocardiographyColoadNCT05435573
Cardiac Output in Preeclamptic
A study testing 1000 mL of ringer's acetate solution and 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven) in people with Echocardiography, run by Mansoura University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Echocardiography
- What is being tested?
- 1000 mL of ringer's acetate solution and 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 17 Aug 2022to 3 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Pre-eclampsia
- Age 18-45 years.
- Singleton pregnancy scheduled for elective CS delivery under spinal anesthesia.
- American Society of Anesthesiologists (ASA Ⅱ, Ⅲ).
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University-Emergency hospital-ICU
Al Mansurah, Mansoura, 35511
About this study
Official title: Coload Effect on Cardiac Output Measurement Using Transthoracic Echocardiography in Preeclamptic Patients Undergoing Cesarean Delivery
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.
Read the detailed description
Transthoracic echocardiography considered an accurate non-invasive device and has validity for measuring cardiac functions in pregnancy.
- Conditions
- Echocardiography
- Being tested
- 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)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1000 mL of ringer's acetate solutionDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid group | Active comparator | The patients will receive 1000 mL of ringer's acetate solution (250 mL over 5 minutes starting immediately after intrathecal injection using a pressurizer then 500 mL over 55 minutes then 250 mL over 60 minutes). Receives: Drug: 1000 mL of ringer's acetate solution |
| Crystalloid-colloid group | Active comparator | Patients will receive 250 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride starting immediately after intrathecal injection then 500 mL of ringer's acetate solution then 250 mL of hydroxyethyl starch Receives: Drug: 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac output measurement
1 hour post spinal anesthesia after administration of 1000 mL fluid using Transthoracic Echocardiography
Measured: 1 hour from the spinal anesthesia
Secondary outcomes (5)
Cardiac output measurement
at baseline ,5 minutes after spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia
Measured: 5 minutes after the spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia
Left ventricular end diastolic volume (LVEDV) measurement
milliliter
Measured: 1 hour from the spinal anesthesia
Urine output volume
milliliters
Measured: 1hour and 2 hours post spinal anesthesia
Heart rate (HR)
beats per minute
Measured: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Mean Blood pressure
mmHg
Measured: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start17 Aug 2022
- Primary completion15 Sep 2023
- Study completion3 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EchocardiographyStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomly allocated via sealed opaque envelops into 2 groups of 17 patients each; crystalloid group and group crystalloid-colloid group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435573
- Sponsor's protocol ID
- ECHO
- Acronym
- Coload
- Status last verified
- Feb 2026
- First submitted
- 17 Jun 2022
- Last updated
- 17 Feb 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 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Coload Effect on Cardiac Output Measurement Using Transthoracic Echocardiography in Preeclamptic Patients Undergoing Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05435573
- Acronym / sponsor ID
- Coload / ECHO
- Conditions
- Echocardiography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 15 Sep 2023 (actual)
- Study completion
- 3 Jun 2024 (actual)
- First posted
- 28 Jun 2022 (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.
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.
Detailed description
Transthoracic echocardiography considered an accurate non-invasive device and has validity for measuring cardiac functions in pregnancy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Patients will be randomly allocated via sealed opaque envelops into 2 groups of 17 patients each; crystalloid group and group crystalloid-colloid group
| Arm | Type | Receives |
|---|---|---|
| Crystalloid group | Active comparator | Drug: 1000 mL of ringer's acetate solutionThe patients will receive 1000 mL of ringer's acetate solution (250 mL over 5 minutes starting immediately after intrathecal injection using a pressurizer then 500 mL over 55 minutes then 250 mL over 60 minutes). |
| Crystalloid-colloid group | Active comparator | Drug: 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven)Patients will receive 250 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride starting immediately after intrathecal injection then 500 mL of ringer's acetate solution then 250 mL of hydroxyethyl starch |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Pre-eclampsia
- Age 18-45 years.
- Singleton pregnancy scheduled for elective CS delivery under spinal anesthesia.
- American Society of Anesthesiologists (ASA Ⅱ, Ⅲ).
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| 1000 mL of ringer's acetate solution1000 mL of ringer's acetate solution | Drug | Crystalloid group |
| 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven)500 mL 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride plus 500 mL of ringer's acetate solution | Drug | Crystalloid-colloid group |
Primary outcome
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
5 secondary outcomes
Cardiac output measurement
Time frame: 5 minutes after the spinal anesthesia, after delivery of the fetus and 2 hours post spinal anesthesia
Left ventricular end diastolic volume (LVEDV) measurement
Time frame: 1 hour from the spinal anesthesia
Urine output volume
Time frame: 1hour and 2 hours post spinal anesthesia
Heart rate (HR)
Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Mean Blood pressure
Time frame: basal (preoperative), intraoperative each 10 minutes and postoperatively every hour during first 6 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 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. This study is not recruiting at the moment.
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 study testing 1000 mL of ringer's acetate solution and 250 mL 6% hydroxyethyl starch (Voluven) then 500 mL of ringer's acetate solution then 250 mL of 6% hydroxyethyl starch (Voluven) in people with Echocardiography, run by Mansoura University at 1 site in Egypt.
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 4 inclusion and 8 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: finished, as of the sponsor's last update on 17 Feb 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 Egypt. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Cardiac output measurement (time frame: 1 hour from the spinal anesthesia). 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 17 Feb 2026.