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Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section

M

Mansoura University

Status

Completed

Conditions

Preeclampsia
Elective Cesarean Section

Treatments

Drug: Intrathecal Bupivacaine
Procedure: Spinal Anesthesia
Procedure: Cesarean Delivery
Other: Ultrasound Assessment of the Inferior Vena Cava
Drug: ringer acetate
Drug: Intravenous Ephedrine
Drug: Intrathecal Fentanyl
Other: Optic nerve sheath diameter
Radiation: lung ultrasound scans
Drug: Intravenous Syntocinon

Study type

Observational

Funder types

Other

Identifiers

NCT04370847
MD.19.10.235

Details and patient eligibility

About

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)

Full 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.

Enrollment

100 patients

Sex

Female

Ages

19 to 45 years old

Volunteers

No Healthy Volunteers

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.

Trial design

100 participants in 1 patient group

Lung Ultrasound (LUS) Examination
Description:
Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients
Treatment:
Drug: Intravenous Syntocinon
Other: Optic nerve sheath diameter
Radiation: lung ultrasound scans
Drug: Intrathecal Fentanyl
Drug: Intravenous Ephedrine
Drug: ringer acetate
Other: Ultrasound Assessment of the Inferior Vena Cava
Procedure: Cesarean Delivery
Drug: Intrathecal Bupivacaine
Procedure: Spinal Anesthesia

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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