Clinical trial NCT04370847: Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section
Official title: Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Elective Cesarean Section Under Spinal Anesthesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Elective Cesarean Section
Preeclampsia
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 100
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

Brief 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. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Ultrasonographic fluid assessment
timeFrame: Time frame:preoperative(baseline) and 2 hours after spinal anesthesia.
Secondary outcomes:
measure: Urine output
timeFrame: For 2 hours after spinal anesthesia
measure: Oliguria
timeFrame: For 2 hours after spinal anesthesia
measure: Ephedrine use
timeFrame: Intraoperative
measure: Intraoperative bradycardia
timeFrame: Intraoperative
measure: Incidence of nausea and vomiting.
timeFrame: Intraoperative
measure: Difference between overall number of b lines
timeFrame: baseline and 1hour post spinal
measure: Inferior Vena Caval Diameters
timeFrame: Baseline, and at 1 and 2 hours post-spinal
measure: Difference between optic nerve sheath diameter
timeFrame: baseline,at 1hour and at 2 hours of spinal anesthesia.
measure: Neonatal Apgar score
timeFrame: 5 min after delivery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
state: DK
Study officials:
affiliation: Professor of Anesthesia and Surgical Intensive care,
name: Aboelnour E Aboelnour, MD
role: STUDY_CHAIR
affiliation: Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.
name: Hanaa A Elbendary, MD
role: STUDY_DIRECTOR
affiliation: Lecturer of Anesthesia and Surgical Intensive care,
name: Marwa L Abdo, MD
role: STUDY_DIRECTOR
affiliation: Lecturer of Anesthesia and Surgical Intensive care
name: Sherine A Bakrey, MD
role: STUDY_DIRECTOR
References: