Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section

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)

Study Overview

• Status: Completed
• Conditions: Preeclampsia; Elective Cesarean Section
• Intervention / Treatment: Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Procedure: Cesarean Delivery; Drug: Intravenous Ephedrine; Procedure: Spinal Anesthesia; Radiation: lung ultrasound scans; Other: Ultrasound Assessment of the Inferior Vena Cava; Other: Optic nerve sheath diameter; Drug: ringer acetate; Drug: Intravenous Syntocinon

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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Egypt
  • DK
    • Mansoura, DK, Egypt, 050
      • Mansoura university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 45 years (Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Probability Sample

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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Lung Ultrasound (LUS) Examination; Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients

Drug: Intrathecal Bupivacaine; Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space; Drug: Intrathecal Fentanyl; Fentanyl 15 μg will be administered in the subarachnoid space; Procedure: Cesarean Delivery; Lower segment cesarean section using the Pfannenstiel incision; Drug: Intravenous Ephedrine; Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.; Procedure: Spinal Anesthesia; Performed at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle; Radiation: lung ultrasound scans; 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.; Other: Ultrasound Assessment of the Inferior Vena Cava; 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.; Other: Optic nerve sheath diameter; 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.; Drug: ringer acetate; 1000 ml ringer acetate will be administered over 2 hours.; Drug: Intravenous Syntocinon; Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ultrasonographic fluid assessment	Detection of change in overall number of B lines (ECS) by lung ultrasound	Time frame:preoperative(baseline) and 2 hours after spinal anesthesia.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urine output	total urine output at 2 hours after spinal anesthesia	For 2 hours after spinal anesthesia
Oliguria	Incidence of oliguria defined as a total urine output <60 mL/hr	For 2 hours after spinal anesthesia
Ephedrine use	total ephedrine dose	Intraoperative
Intraoperative bradycardia	Incidence of bradycardia (Heart rate <50 beats/minute)	Intraoperative
Incidence of nausea and vomiting.	Incidence of nausea and/or vomiting as reported by the patient	Intraoperative
Difference between overall number of b lines	difference between overall number of b lines preoperative(baseline) and at 1 hour after spinal anesthesia.	baseline and 1hour post spinal
Inferior Vena Caval Diameters	Maximum, minimum inferior vena cava diameters and inferior vena cava collapsibility index changes over time.	Baseline, and at 1 and 2 hours post-spinal
Difference between optic nerve sheath diameter	optic nerve sheath diameter changes over time.	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	5 min after delivery

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Chair: Aboelnour E Aboelnour, MD, Professor of Anesthesia and Surgical Intensive care,; Study Director: Hanaa A Elbendary, MD, Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.; Principal Investigator: Marwa L Abdo, MD, lecturer of Anesthesia and Surgical Intensive care,

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): August 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: April 29, 2020
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 30, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Pre-Eclampsia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Reproductive Control Agents; Central Nervous System Stimulants; Oxytocics; Sympathomimetics; Vasoconstrictor Agents; Fentanyl; Oxytocin; Bupivacaine; Ephedrine
• Other Study ID Numbers: MD.19.10.235

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: The data will be available following publication for life-long.
• IPD Sharing Access Criteria: the data will be accessible to the investigators .and the PRS administrators with hiding the identifiers for the patients
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No