Elective Cesarean SectionNCT04370847
Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section
An observational study of Elective Cesarean Section and Preeclampsia, run by Mansoura University at 1 site in Egypt.
Trial summary
Preeclampsia is a multifocal syndrome reported in 2-8 % of pregnancies. It is diagnosed in the second half of pregnancy by two separate measurements of systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥ 90 mmHg in the same arm and proteinuria >300 mg in 24 h urine collection. Read more about this study
- Who is it for?
- Ages 19 to 45 years, women only
- Conditions the study is for
- Elective Cesarean Section, Preeclampsia
- What is being tested?
- Spinal Anesthesia, Intrathecal Bupivacaine and Intrathecal Fentanyl
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2020to 1 Dec 2021
- Phase
- Observational
- 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 19 to 45 years
- Women only
- Adult
Study population: The calculated sample size of the study will be 70 parturients at 5% level of significance and 80 % power, using the following formula: N= (Z1-α/2+Z1-β) ² σ1* σ2 / δ ² *2 Z1-α/2 = 1.96 Z1-β= 0.842 σ = SD (8, 9) δ = Expected difference to be detected before and after delivery (4). α = Level of acceptability of a false positive result (level of significance=0.05). β = Level of acceptability of a false negative result (0.20). 1- β= power (0.80).The sample size will be increased to 100 parturients to compensate for protocol failures with incomplete data and to increase the power of the study.
Who may be able to join
- Singleton pregnancy.
- 32 - 41 weeks gestational age.
- Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick
- Elective cesarean delivery under spinal anesthesia.
Who cannot join
- Body mass index (BMI) ≥40 kg/m2.
- Significant cardiovascular disease
- Other obstetrical problems
- Other uteroplacental problems
- Abruption placenta.
- Already treated for acute lung pathology prior to enrollment.
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- Contraindications to spinal anesthesia.
- INR >1.5 or PLT<100,000 /mm3.
- Women presenting in labor.
- Previous thoracic surgery.
- Previous ocular surgery
- Ocular trauma
- Glaucoma.
- Preoperative pulmonary disease:
- Increased serum creatinine level ≥1.1 mg/dL.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Elective Cesarean Section Under Spinal Anesthesia
Preeclampsia is a multifocal syndrome reported in 2-8 % of pregnancies. It is diagnosed in the second half of pregnancy by two separate measurements of systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥ 90 mmHg in the same arm and proteinuria >300 mg in 24 h urine collection. The risk for serious complications such as pulmonary edema, cerebrovascular accidents, coagulopathy, and hemorrhage is 10 to 30 fold higher among parturients with severe preeclampsia.
Severe preeclampsia is defined by one or more of the following clinical features: severe hypertension (systolic arterial pressure 160 mmHg and/or diastolic arterial pressure 110 mmHg on more than one occasion at least 4 h apart while the patient is on bed rest, renal dysfunction (serum creatinine >1.1mg/dl or doubling of serum creatinine in the absence of another renal disease, platelet count less than <100,000 mm3, acute pulmonary edema, epigastric pain not responding to medical treatment, new-onset cerebral and visual manifestation, hemolysis, elevated liver enzymes and low platelet count syndrome (HELLP syndrome)
Read the detailed description
Fluid resuscitation is a key determinant in the management of these parturients. Hypovolemia exacerbates organ failure, whereas volume overload results in pulmonary edema. In this setting, the use of noninvasive hemodynamic monitoring is associated with reduced mortality.
Point-of-care lung ultrasonography is used in many critical care settings as the initial diagnostic imaging study for patients with respiratory symptoms. It is highly sensitive for the diagnosis of pulmonary edema which may occur even without cardiomyopathy or heart failure.
The IVC is a highly compliant vessel that changes its diam¬eter in parallel with changes in blood volume and central venous pressure. Measurement of IVC diameter and col¬lapsibility index using ultrasound through a subcostal approach has been investigated in patients of various settings. The IVC-CI imaging technique may be used to assess the volume status in healthy parturients undergoing routine cesarean delivery as well as in high-risk parturients as preeclampsia.
Cerebral edema is predominantly vasogenic and may be related to the failure of cerebral autoregulation with subsequent hyperperfusion, blood-brain barrier disruption, and endothelial cell dysfunction. Ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of raised ICP.
- Conditions
- Elective Cesarean Section, Preeclampsia
- Being tested
- Spinal Anesthesia, Intrathecal Bupivacaine, Intrathecal Fentanyl, Cesarean Delivery, lung ultrasound scans
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal AnesthesiaProcedure or surgery
Performed at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle
Intrathecal BupivacaineDrug
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Intrathecal FentanylDrug
Fentanyl 15 μg will be administered in the subarachnoid space
Cesarean DeliveryProcedure or surgery
Lower segment cesarean section using the Pfannenstiel incision
lung ultrasound scansRadiation
lung ultrasound scans will be performed while the patient is in the supine position with left lateral tilt by 30 degrees using a 2-5 MHz curved array transducer. The echo comet score (ECS) which corresponds to the amount of EVLW will be obtained by the 28-rib interspaces technique. An increased amount of (EVLW) is diagnosed by multiple B-lines or 'comet tails' which are defined as discrete laser-like vertical hyperechoic reverberation artifacts that arise from the pleural line and extend to the bottom of the screen without fading and move synchronously with lung sliding. The sum of the B-lines found on each of the 28 chest-wall areas yields the ECS.
Ultrasound Assessment of the Inferior Vena CavaOther
The IVC largest and smallest diameters will be measured proximal to the opening of the M-mode using s2-4 MHz transducer placed longitudinally in the subcostal region.
Optic nerve sheath diameterOther
Optic nerve sheath diameter measurement will be conducted in two axes of transverse and oblique sagittal using a 12-4MHz linear array transducer. Depth of the optic nerve will be localized and marked at 3 mm behind the retinal and optic nerve junction transverse diameter of optic nerve sheath will be calculated. The reported ONSD corresponds to the mean of the four values obtained for each patient transverse and sagittal plane for both eyes.
ringer acetateDrug
1000 ml ringer acetate will be administered over 2 hours.
Intravenous EphedrineDrug
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
Intravenous SyntocinonDrug
Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution.
| Study group | Role | What they receive |
|---|---|---|
| Lung Ultrasound (LUS) Examination | Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients Receives: Procedure: Spinal Anesthesia; Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Procedure: Cesarean Delivery; Radiation: lung ultrasound scans; Other: Ultrasound Assessment of the Inferior Vena Cava; Other: Optic nerve sheath diameter; Drug: ringer acetate; Drug: Intravenous Ephedrine; Drug: Intravenous Syntocinon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasonographic fluid assessment
Detection of change in overall number of B lines (ECS) by lung ultrasound
Measured: Time frame:preoperative(baseline) and 2 hours after spinal anesthesia.
Secondary outcomes (9)
Urine output
total urine output at 2 hours after spinal anesthesia
Measured: For 2 hours after spinal anesthesia
Oliguria
Incidence of oliguria defined as a total urine output <60 mL/hr
Measured: For 2 hours after spinal anesthesia
Ephedrine use
total ephedrine dose
Measured: Intraoperative
Intraoperative bradycardia
Incidence of bradycardia (Heart rate <50 beats/minute)
Measured: Intraoperative
Incidence of nausea and vomiting.
Incidence of nausea and/or vomiting as reported by the patient
Measured: Intraoperative
Difference between overall number of b lines
difference between overall number of b lines preoperative(baseline) and at 1 hour after spinal anesthesia.
Measured: baseline and 1hour post spinal
Inferior Vena Caval Diameters
Maximum, minimum inferior vena cava diameters and inferior vena cava collapsibility index changes over time.
Measured: Baseline, and at 1 and 2 hours post-spinal
Difference between optic nerve sheath diameter
optic nerve sheath diameter changes over time.
Measured: baseline,at 1hour and at 2 hours of spinal anesthesia.
Neonatal Apgar score
neonatal Apgar score to assess neonatal wellbeing at 5 min after delivery
Measured: 5 min after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start1 Jun 2020
- Primary completion1 Aug 2021
- Study completion1 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Elective Cesarean SectionStudies of the same condition, open and under way.
- More trials run by Mansoura UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aboelnour E Aboelnour, MD, Study chair, Professor of Anesthesia and Surgical Intensive care,Hanaa A Elbendary, MD, Study director, Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.Marwa L Abdo, MD, Study director, Lecturer of Anesthesia and Surgical Intensive care,Sherine A Bakrey, MD, Study director, Lecturer of Anesthesia and Surgical Intensive care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04370847
- Sponsor's protocol ID
- MD.19.10.235
- Status last verified
- Nov 2024
- First submitted
- 29 Apr 2020
- Last updated
- 13 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Elective Cesarean Section Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT04370847
- Acronym / sponsor ID
- MD.19.10.235
- Conditions
- Elective Cesarean Section, Preeclampsia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Aug 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 1 May 2020 (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.
Preeclampsia is a multifocal syndrome reported in 2-8 % of pregnancies. It is diagnosed in the second half of pregnancy by two separate measurements of systolic blood pressure ≥140 mmHg and/or a diastolic blood pressure ≥ 90 mmHg in the same arm and proteinuria >300 mg in 24 h urine collection. The risk for serious complications such as pulmonary edema, cerebrovascular accidents, coagulopathy, and hemorrhage is 10 to 30 fold higher among parturients with severe preeclampsia.
Severe preeclampsia is defined by one or more of the following clinical features: severe hypertension (systolic arterial pressure 160 mmHg and/or diastolic arterial pressure 110 mmHg on more than one occasion at least 4 h apart while the patient is on bed rest, renal dysfunction (serum creatinine >1.1mg/dl or doubling of serum creatinine in the absence of another renal disease, platelet count less than <100,000 mm3, acute pulmonary edema, epigastric pain not responding to medical treatment, new-onset cerebral and visual manifestation, hemolysis, elevated liver enzymes and low platelet count syndrome (HELLP syndrome)
Detailed description
Fluid resuscitation is a key determinant in the management of these parturients. Hypovolemia exacerbates organ failure, whereas volume overload results in pulmonary edema. In this setting, the use of noninvasive hemodynamic monitoring is associated with reduced mortality.
Point-of-care lung ultrasonography is used in many critical care settings as the initial diagnostic imaging study for patients with respiratory symptoms. It is highly sensitive for the diagnosis of pulmonary edema which may occur even without cardiomyopathy or heart failure.
The IVC is a highly compliant vessel that changes its diam¬eter in parallel with changes in blood volume and central venous pressure. Measurement of IVC diameter and col¬lapsibility index using ultrasound through a subcostal approach has been investigated in patients of various settings. The IVC-CI imaging technique may be used to assess the volume status in healthy parturients undergoing routine cesarean delivery as well as in high-risk parturients as preeclampsia.
Cerebral edema is predominantly vasogenic and may be related to the failure of cerebral autoregulation with subsequent hyperperfusion, blood-brain barrier disruption, and endothelial cell dysfunction. Ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of raised ICP.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lung Ultrasound (LUS) Examination | – | Procedure: Spinal Anesthesia, Drug: Intrathecal Bupivacaine, Drug: Intrathecal Fentanyl, Procedure: Cesarean Delivery, Radiation: lung ultrasound scans, Other: Ultrasound Assessment of the Inferior Vena Cava, Other: Optic nerve sheath diameter, Drug: ringer acetate, Drug: Intravenous Ephedrine, Drug: Intravenous SyntocinonUltrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients |
Who may qualify
- Ages
- 19 to 45 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The calculated sample size of the study will be 70 parturients at 5% level of significance and 80 % power, using the following formula: N= (Z1-α/2+Z1-β) ² σ1* σ2 / δ ² *2 Z1-α/2 = 1.96 Z1-β= 0.842 σ = SD (8, 9) δ = Expected difference to be detected before and after delivery (4). α = Level of acceptability of a false positive result (level of significance=0.05). β = Level of acceptability of a false negative result (0.20). 1- β= power (0.80).The sample size will be increased to 100 parturients to compensate for protocol failures with incomplete data and to increase the power of the study.
Key inclusion criteria (4 listed)
- Singleton pregnancy.
- 32 - 41 weeks gestational age.
- Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick
- Elective cesarean delivery under spinal anesthesia.
Key exclusion criteria (15 listed)
- Body mass index (BMI) ≥40 kg/m2.
- Significant cardiovascular disease
- Other obstetrical problems
- Other uteroplacental problems
- Abruption placenta.
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 |
|---|---|---|
| Spinal AnesthesiaPerformed at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle | Procedure or surgery | Lung Ultrasound (LUS) Examination |
| Intrathecal BupivacaineBupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space | Drug | Lung Ultrasound (LUS) Examination |
| Intrathecal FentanylFentanyl 15 μg will be administered in the subarachnoid space | Drug | Lung Ultrasound (LUS) Examination |
| Cesarean DeliveryLower segment cesarean section using the Pfannenstiel incision | Procedure or surgery | Lung Ultrasound (LUS) Examination |
| lung ultrasound scanslung ultrasound scans will be performed while the patient is in the supine position with left lateral tilt by 30 degrees using a 2-5 MHz curved array transducer. The echo comet score (ECS) which corresponds to the amount of EVLW will be obtained by the 28-rib interspaces technique. An increased amount of (EVLW) is diagnosed by multiple B-lines or 'comet tails' which are defined as discrete laser-like vertical hyperechoic reverberation artifacts that arise from the pleural line and extend to the bottom of the screen without fading and move synchronously with lung sliding. The sum of the B-lines found on each of the 28 chest-wall areas yields the ECS. | Radiation | Lung Ultrasound (LUS) Examination |
| Ultrasound Assessment of the Inferior Vena CavaThe IVC largest and smallest diameters will be measured proximal to the opening of the M-mode using s2-4 MHz transducer placed longitudinally in the subcostal region. | Other | Lung Ultrasound (LUS) Examination |
| Optic nerve sheath diameterOptic nerve sheath diameter measurement will be conducted in two axes of transverse and oblique sagittal using a 12-4MHz linear array transducer. Depth of the optic nerve will be localized and marked at 3 mm behind the retinal and optic nerve junction transverse diameter of optic nerve sheath will be calculated. The reported ONSD corresponds to the mean of the four values obtained for each patient transverse and sagittal plane for both eyes. | Other | Lung Ultrasound (LUS) Examination |
| ringer acetate1000 ml ringer acetate will be administered over 2 hours. | Drug | Lung Ultrasound (LUS) Examination |
| Intravenous EphedrineIntravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively. | Drug | Lung Ultrasound (LUS) Examination |
| Intravenous SyntocinonImmediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution. | Drug | Lung Ultrasound (LUS) Examination |
Primary outcome
Ultrasonographic fluid assessment
Time frame: Time frame:preoperative(baseline) and 2 hours after spinal anesthesia.
Detection of change in overall number of B lines (ECS) by lung ultrasound
9 secondary outcomes
Urine output
Time frame: For 2 hours after spinal anesthesia
Oliguria
Time frame: For 2 hours after spinal anesthesia
Ephedrine use
Time frame: Intraoperative
Intraoperative bradycardia
Time frame: Intraoperative
Incidence of nausea and vomiting.
Time frame: Intraoperative
Difference between overall number of b lines
Time frame: baseline and 1hour post spinal
Inferior Vena Caval Diameters
Time frame: Baseline, and at 1 and 2 hours post-spinal
Difference between optic nerve sheath diameter
Time frame: baseline,at 1hour and at 2 hours of spinal anesthesia.
Neonatal Apgar score
Time frame: 5 min after delivery
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 13 Nov 2024.
- Individual participant dataSharing planned: Yes
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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.
Aboelnour E Aboelnour, MD study chair
Professor of Anesthesia and Surgical Intensive care,
Hanaa A Elbendary, MD study director
Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.
Marwa L Abdo, MD study director
Lecturer of Anesthesia and Surgical Intensive care,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Elective Cesarean Section and Preeclampsia, 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 15 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 13 Nov 2024. 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?
Ultrasonographic fluid assessment (time frame: Time frame:preoperative(baseline) and 2 hours after 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 13 Nov 2024.