PregnancyNCT06654687
Transthoracic Echocardiographic Monitoring of Cardiac Output Effects of Colloid Preload and Crystalloid Coload During Cesarean Delivery Under Spinal Anesthesia
A study testing Transthoracic Echocardiography, Ringer lactate 1000 ml and Albumin in people with Pregnancy and Cesarean Delivery, run by Sameh Fathy at 1 site in Egypt.
Trial summary
Transthoracic echocardiography (TTE) has been introduced in anesthesia and intensive care practice to assess the volume status and predict fluid responsiveness, with a few studies performed on pregnant women (5). Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy, Cesarean Delivery, Spinal Anesthesia Induced Hypotension
- What is being tested?
- Transthoracic Echocardiography, Ringer lactate 1000 ml and Albumin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteEgypt
- Study dates
- 27 Oct 2024to 1 Mar 2025
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists physical status II parturients with full term singleton pregnancies scheduled for elective cesarean delivery under spinal anesthesia.
Who cannot join
- Height <150 cm, weight <55 kg, and body mass index ≥40 kg/m2.
- Women presenting in labor or having any contraindication to spinal anesthesia (patient refusal, increased intracranial pressure, coagulation disorders, or local skin infection).
- Chronic or pregnancy-induced hypertension; baseline systolic blood pressure >140 mm Hg.
- Hemoglobin <10 g/dL.
- Diabetes mellitus.
- Cardiovascular, cerebrovascular, or renal disease.
- Polyhydramnios or fetal abnormalities.
Trial locations and contacts
1 site in 1 country.
About this study
Transthoracic echocardiography (TTE) has been introduced in anesthesia and intensive care practice to assess the volume status and predict fluid responsiveness, with a few studies performed on pregnant women (5).
In this study, we aim to evaluate the effect of intravenous administration of albumin as a colloid preload on the maternal stroke volume (SV) and cardiac output (CO) versus crystalloid coload. We used TTE to measure the changes in SV, and CO at baseline and at subsequent time points after spinal anesthesia.
Read the detailed description
This prospective randomized controlled, double-blind study will be conducted at the obstetrics and gynecology operation room, at Qassim University Medical City.
Written informed consent will be obtained from eligible subjects on the day of the surgery. The study subjects will be randomized using the R software, version 3.5.2 (R Core Team, 2018; R Foundation for Statistical Computing, Vienna, Austria). Subjects will randomly be assigned to 2 equal groups (combined and crystalloid coload) using the permuted block randomization method with randomly selected block sizes of 4 and 6. The group allocation codes will be hidden in sequentially numbered, opaque, sealed envelopes that will be opened only after assessing the eligibility and obtaining the consent from the subjects. The study subjects and the outcome assessors will be blinded to the study group.
Spinal anesthesia will be conducted will be assessed respectively by an anesthesiologist not involved in the study.
All transthoracic cardiography images will be obtained by the second investigator who have the experience of accomplishing > 500 cases before starting the study using the technique and guidelines reported in American Society of Echocardiography . During obtaining the images intraoperatively, the investigator will be separated from the surgical field by a sterile drape, and the ultrasound probe will be covered with a sterile cover.
The study subjects will enter the operating room, lying supine on the operating table with slight left lateral position by tilting the operating table to the left. Standard monitors will be attached to all patients (noninvasive blood pressure, pulse oximeter, and electrocardiography). Basal systolic blood pressure and heart rate will be recorded after a period of rest, the average of 3 readings, 2 minutes apart will be recorded. Basal transthoracic cardiography images will be obtained.
Two 18-gauge intravenous cannula will be inserted in two large veins of the right forearm, one for IV fluids, and the other for phenylephrine infusion. In the combination group, patients will receive 250 mL of human albumin 5% (Human Albumin 50 gm/L, BAXTER, Austria) immediately before induction of spinal anesthesia (SA), over 10 minutes using an infusion pump (Fresenius Kabi Agilia Volumat MC Infusion Pump, Germany), and 750 mL of Ringer's lactate solution, to be started during the intrathecal injection of the local anesthetic, and infused over 15 minutes. In the crystalloid coload group, patients will receive 1000 mL of Ringer's lactate solution, to be started during the intrathecal injection of the local anesthetic, and infused over 15 minutes. In both groups, phenylephrine infusion will be given prophylactically, and will be started during the intrathecal injection of the local anesthetic at a dose ranging from 25-50 mcg/minute to maintain the SBP within 20 % of the basal readings. After administering the study solutions, Ringer's lactate will be attached to the IV cannula and will be administered at a rate of 1 mL/min; no other fluids will be administered until clamping of the umbilical cord (end of the study period).
In the sitting position, spinal anesthesia will be conducted by intrathecal injection of hyperbaric bupivacaine 12.5 mg 0.5% and fentanyl 15 microgram, using 27-gauge pencil point spinal needle at L3-L4 intervertebral space.
Surgery will be started after reaching at least an upper sensory level of T4; below this level, spinal anesthesia will be considered failed and patients will be excluded from the study.
SV and CO will be measured at 5 time points (basal readings, 1 minute after SA, 5 minutes after SA, immediately after delivery of the baby and clamping the cord, and 1 hour after the end of the study). SBP and HR will be recorded ever minute till the delivery of the baby, then every 3 minutes till the end of the surgery.
- Conditions
- Pregnancy, Cesarean Delivery, Spinal Anesthesia Induced Hypotension, Cardiac Output Measurement, Volume Status
- Being tested
- Transthoracic Echocardiography, Ringer lactate 1000 ml, Albumin, Ringer lactate 750 ml
- Keywords
- Cardiac output- Transthoracic ECHO - Colloids - Crystalloids - Cesarean delivery - Spinal anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transthoracic EchocardiographyDevice
Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.
Ringer lactate 1000 mlDrug
Patients will receive 1000 mL of Ringer's lactate solution over 15 minutes.
AlbuminDrug
Patients will receive 250 mL of human albumin 5% over 10 minutes
Ringer lactate 750 mlDrug
Patients will receive 750 mL of Ringer's lactate solution over 15 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Crystalloid group | Active comparator | Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.
Patients will receive 1000 mL of Ringer's lactate solution over 15 minutes. Receives: Device: Transthoracic Echocardiography; Drug: Ringer lactate 1000 ml |
| Combination group | Active comparator | Transthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output.
Patients will receive 250 mL of human albumin 5% over 10 minutes and 750 mL of Ringer's lactate solution over 15 minutes. Receives: Device: Transthoracic Echocardiography; Drug: Albumin; Drug: Ringer lactate 750 ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Cardiac Output
The changes in Cardiac Output are measured relative to baseline immediately after delivery
Measured: Immediately after delivery of baby
Secondary outcomes (9)
Changes in stroke volume
The changes in stroke volume are measured compared to the baseline immediately after delivery
Measured: Immediately after delivery of baby
Total phenylephrine dose (mg)
Measured: Until delivery of baby
Total ephedrine dose (mg)
Measured: Until delivery of the baby
Total glycopyrrolate dose (mg)
Measured: Until delivery of the baby
Incidence of hypotension
Decrease in SBP > 20% of the basal reading
Measured: Until end of surgery
Incidence of bradycardia
Heart rate < 50 beats/minute
Measured: Until end of surgery
Incidence of nausea and/or vomiting
Measured: Until end of surgery
Measurement of APGAR score
APGAR score includes appearance, pulse, grimace, activity and respiration
Measured: 1 minute and 5 minutes after delivery of the baby
Measurement of Urine output (ml)
Measured: 1 hour after delivery of the baby
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2024
- Study start27 Oct 2024
- Primary completion15 Feb 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sameh Fathy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sameh Fathy, Mansoura University
- Investigators
- MOHAMED TOLBA ELMORSY, MD, Principal investigator, Lecturer of Anesthesia and ICU - Faculty of Medicine - Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06654687
- Sponsor's protocol ID
- ECHO for CO monitoring in CD
- Status last verified
- May 2025
- First submitted
- 22 Oct 2024
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Porter TR, Shillcutt SK, Adams MS, Desjardins G, Glas KE, Olson JJ, Troughton RW. Guidelines for the use of echocardiography as a monitor for therapeutic intervention in adults: a report from the American Society of Echocardiography. J Am Soc Echocardiogr. 2015 Jan;28(1):40-56. doi: 10.1016/j.echo.2014.09.009. No abstract available.
PubMed 25559474Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
PubMed 20620859McDonald S, Fernando R, Ashpole K, Columb M. Maternal cardiac output changes after crystalloid or colloid coload following spinal anesthesia for elective cesarean delivery: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):803-10. doi: 10.1213/ANE.0b013e31822c0f08. Epub 2011 Sep 2.
PubMed 21890886Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
PubMed 26580836Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. No abstract available.
PubMed 21948275Loubert C. Fluid and vasopressor management for Cesarean delivery under spinal anesthesia: continuing professional development. Can J Anaesth. 2012 Jun;59(6):604-19. doi: 10.1007/s12630-012-9705-9. Epub 2012 Apr 24. English, French.
PubMed 22528166Tolba MA, Abaalkhayl M, Alkhuraif RA, Alobaid AF, Aldubayan RS, Alotaibi NS. Transthoracic echocardiographic evaluation of maternal cardiac output: colloid preload versus crystalloid coload during cesarean delivery under spinal anesthesia: randomized clinical trial. BMC Anesthesiol. 2026 Mar 12;26(1):247. doi: 10.1186/s12871-026-03702-5.
PubMed 41814182
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transthoracic Echocardiographic Monitoring of Cardiac Output Effects of Colloid Preload and Crystalloid Coload During Cesarean Delivery Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT06654687
- Acronym / sponsor ID
- ECHO for CO monitoring in CD
- Conditions
- Pregnancy, Cesarean Delivery, Spinal Anesthesia Induced Hypotension, Cardiac Output Measurement, Volume Status
- Keywords
- Cardiac output- Transthoracic ECHO - Colloids - Crystalloids - Cesarean delivery - Spinal anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Sameh FathyUniversity, hospital or other
- Study start
- 27 Oct 2024 (actual)
- Primary completion
- 15 Feb 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 23 Oct 2024 (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.
Transthoracic echocardiography (TTE) has been introduced in anesthesia and intensive care practice to assess the volume status and predict fluid responsiveness, with a few studies performed on pregnant women (5).
In this study, we aim to evaluate the effect of intravenous administration of albumin as a colloid preload on the maternal stroke volume (SV) and cardiac output (CO) versus crystalloid coload. We used TTE to measure the changes in SV, and CO at baseline and at subsequent time points after spinal anesthesia.
Detailed description
This prospective randomized controlled, double-blind study will be conducted at the obstetrics and gynecology operation room, at Qassim University Medical City.
Written informed consent will be obtained from eligible subjects on the day of the surgery. The study subjects will be randomized using the R software, version 3.5.2 (R Core Team, 2018; R Foundation for Statistical Computing, Vienna, Austria). Subjects will randomly be assigned to 2 equal groups (combined and crystalloid coload) using the permuted block randomization method with randomly selected block sizes of 4 and 6. The group allocation codes will be hidden in sequentially numbered, opaque, sealed envelopes that will be opened only after assessing the eligibility and obtaining the consent from the subjects. The study subjects and the outcome assessors will be blinded to the study group.
Spinal anesthesia will be conducted will be assessed respectively by an anesthesiologist not involved in the study.
All transthoracic cardiography images will be obtained by the second investigator who have the experience of accomplishing > 500 cases before starting the study using the technique and guidelines reported in American Society of Echocardiography . During obtaining the images intraoperatively, the investigator will be separated from the surgical field by a sterile drape, and the ultrasound probe will be covered with a sterile cover.
The study subjects will enter the operating room, lying supine on the operating table with slight left lateral position by tilting the operating table to the left. Standard monitors will be attached to all patients (noninvasive blood pressure, pulse oximeter, and electrocardiography). Basal systolic blood pressure and heart rate will be recorded after a period of rest, the average of 3 readings, 2 minutes apart will be recorded. Basal transthoracic cardiography images will be obtained.
Two 18-gauge intravenous cannula will be inserted in two large veins of the right forearm, one for IV fluids, and the other for phenylephrine infusion. In the combination group, patients will receive 250 mL of human albumin 5% (Human Albumin 50 gm/L, BAXTER, Austria) immediately before induction of spinal anesthesia (SA), over 10 minutes using an infusion pump (Fresenius Kabi Agilia Volumat MC Infusion Pump, Germany), and 750 mL of Ringer's lactate solution, to be started during the intrathecal injection of the local anesthetic, and infused over 15 minutes. In the crystalloid coload group, patients will receive 1000 mL of Ringer's lactate solution, to be started during the intrathecal injection of the local anesthetic, and infused over 15 minutes. In both groups, phenylephrine infusion will be given prophylactically, and will be started during the intrathecal injection of the local anesthetic at a dose ranging from 25-50 mcg/minute to maintain the SBP within 20 % of the basal readings. After administering the study solutions, Ringer's lactate will be attached to the IV cannula and will be administered at a rate of 1 mL/min; no other fluids will be administered until clamping of the umbilical cord (end of the study period).
In the sitting position, spinal anesthesia will be conducted by intrathecal injection of hyperbaric bupivacaine 12.5 mg 0.5% and fentanyl 15 microgram, using 27-gauge pencil point spinal needle at L3-L4 intervertebral space.
Surgery will be started after reaching at least an upper sensory level of T4; below this level, spinal anesthesia will be considered failed and patients will be excluded from the study.
SV and CO will be measured at 5 time points (basal readings, 1 minute after SA, 5 minutes after SA, immediately after delivery of the baby and clamping the cord, and 1 hour after the end of the study). SBP and HR will be recorded ever minute till the delivery of the baby, then every 3 minutes till the end of the surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Crystalloid group | Active comparator | Device: Transthoracic Echocardiography, Drug: Ringer lactate 1000 mlTransthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output. Patients will receive 1000 mL of Ringer's lactate solution over 15 minutes. |
| Combination group | Active comparator | Device: Transthoracic Echocardiography, Drug: Albumin, Drug: Ringer lactate 750 mlTransthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output. Patients will receive 250 mL of human albumin 5% over 10 minutes and 750 mL of Ringer's lactate solution over 15 minutes. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- American Society of Anesthesiologists physical status II parturients with full term singleton pregnancies scheduled for elective cesarean delivery under spinal anesthesia.
Key exclusion criteria (7 listed)
- Height <150 cm, weight <55 kg, and body mass index ≥40 kg/m2.
- Women presenting in labor or having any contraindication to spinal anesthesia (patient refusal, increased intracranial pressure, coagulation disorders, or local skin infection).
- Chronic or pregnancy-induced hypertension; baseline systolic blood pressure >140 mm Hg.
- Hemoglobin <10 g/dL.
- Diabetes mellitus.
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 |
|---|---|---|
| Transthoracic EchocardiographyTransthoracic Echocardiography will be used to measure the changes in stroke volume and cardiac output. | Device | Combination group, Crystalloid group |
| Ringer lactate 1000 mlPatients will receive 1000 mL of Ringer's lactate solution over 15 minutes. | Drug | Crystalloid group |
| AlbuminPatients will receive 250 mL of human albumin 5% over 10 minutes | Drug | Combination group |
| Ringer lactate 750 mlPatients will receive 750 mL of Ringer's lactate solution over 15 minutes. | Drug | Combination group |
Primary outcome
Changes in Cardiac Output
Time frame: Immediately after delivery of baby
The changes in Cardiac Output are measured relative to baseline immediately after delivery
9 secondary outcomes
Changes in stroke volume
Time frame: Immediately after delivery of baby
Total phenylephrine dose (mg)
Time frame: Until delivery of baby
Total ephedrine dose (mg)
Time frame: Until delivery of the baby
Total glycopyrrolate dose (mg)
Time frame: Until delivery of the baby
Incidence of hypotension
Time frame: Until end of surgery
Incidence of bradycardia
Time frame: Until end of surgery
Incidence of nausea and/or vomiting
Time frame: Until end of surgery
Measurement of APGAR score
Time frame: 1 minute and 5 minutes after delivery of the baby
Measurement of Urine output (ml)
Time frame: 1 hour after delivery of the baby
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 21 May 2025.
- Background: PubMed 25559474Porter TR, Shillcutt SK, Adams MS, Desjardins G, Glas KE, Olson JJ, Troughton RW. Guidelines for the use of echocardiography as a monitor for therapeutic intervention in adults: a report from the American Society of Echocardiography. J Am Soc Echocardiogr. 2015 Jan;28(1):40-56. doi: 10.1016/j.echo.2014.09.009. No abstract available.
- Background: PubMed 20620859Rudski LG, Lai WW, Afilalo J, Hua L, Handschumacher MD, Chandrasekaran K, Solomon SD, Louie EK, Schiller NB. Guidelines for the echocardiographic assessment of the right heart in adults: a report from the American Society of Echocardiography endorsed by the European Association of Echocardiography, a registered branch of the European Society of Cardiology, and the Canadian Society of Echocardiography. J Am Soc Echocardiogr. 2010 Jul;23(7):685-713; quiz 786-8. doi: 10.1016/j.echo.2010.05.010. No abstract available.
- Background: PubMed 21890886McDonald S, Fernando R, Ashpole K, Columb M. Maternal cardiac output changes after crystalloid or colloid coload following spinal anesthesia for elective cesarean delivery: a randomized controlled trial. Anesth Analg. 2011 Oct;113(4):803-10. doi: 10.1213/ANE.0b013e31822c0f08. Epub 2011 Sep 2.
- Background: PubMed 26580836Practice Guidelines for Obstetric Anesthesia: An Updated Report by the American Society of Anesthesiologists Task Force on Obstetric Anesthesia and the Society for Obstetric Anesthesia and Perinatology. Anesthesiology. 2016 Feb;124(2):270-300. doi: 10.1097/ALN.0000000000000935. No abstract available.
- Background: PubMed 21948275Mercier FJ. Fluid loading for cesarean delivery under spinal anesthesia: have we studied all the options? Anesth Analg. 2011 Oct;113(4):677-80. doi: 10.1213/ANE.0b013e3182245af4. No abstract available.
- Background: PubMed 22528166Loubert C. Fluid and vasopressor management for Cesarean delivery under spinal anesthesia: continuing professional development. Can J Anaesth. 2012 Jun;59(6):604-19. doi: 10.1007/s12630-012-9705-9. Epub 2012 Apr 24. English, French.
- Derived from this study: PubMed 41814182Tolba MA, Abaalkhayl M, Alkhuraif RA, Alobaid AF, Aldubayan RS, Alotaibi NS. Transthoracic echocardiographic evaluation of maternal cardiac output: colloid preload versus crystalloid coload during cesarean delivery under spinal anesthesia: randomized clinical trial. BMC Anesthesiol. 2026 Mar 12;26(1):247. doi: 10.1186/s12871-026-03702-5.
- Individual participant dataSharing planned: Undecided
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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.
MOHAMED TOLBA ELMORSY, MD principal investigator
Lecturer of Anesthesia and ICU - Faculty of Medicine - Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transthoracic Echocardiography, Ringer lactate 1000 ml and Albumin in people with Pregnancy and Cesarean Delivery, run by Sameh Fathy 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 1 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: finished, as of the sponsor's last update on 21 May 2025. 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?
Changes in Cardiac Output (time frame: Immediately after delivery of baby). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06654687, which also lists 7 linked publications.
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 21 May 2025.