Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section

NCT04370847 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2024-11-13

No results posted yet for this study

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)

Conditions

Interventions

PROCEDURE

Spinal Anesthesia

Performed at the L3-L4 or L4-L5 interspace using a 25-gauge spinal needle

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

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 Ephedrine

Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.

DRUG

Intravenous Syntocinon

Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Aboelnour E Aboelnour, MD · Professor of Anesthesia and Surgical Intensive care,

  • Hanaa A Elbendary, MD · Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.

  • Marwa L Abdo, MD · Lecturer of Anesthesia and Surgical Intensive care,

  • Sherine A Bakrey, MD · Lecturer of Anesthesia and Surgical Intensive care

Eligibility

Min Age
19 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-01
Primary Completion
2021-08-01
Completion
2021-12-01

Countries

  • Egypt

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04370847 on ClinicalTrials.gov