Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Cesarean Section

NCT04370847 | Completed DMC

• 1 other identifier: MD.19.10.235
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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)

Conditions

Elective Cesarean Section; Preeclampsia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Urine output

  For 2 hours after spinal anesthesia

• Oliguria

  For 2 hours after spinal anesthesia

• Ephedrine use

  Intraoperative

• Intraoperative bradycardia

  Intraoperative

• Incidence of nausea and vomiting.

  Intraoperative

Study Arms (1)

Lung Ultrasound (LUS) Examination

Ultrasonographic assessment of fluid status through scanning the lungs would be performed in all included patients

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

Interventions

Spinal Anesthesia PROCEDURE

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

Lung Ultrasound (LUS) Examination

Intrathecal Bupivacaine DRUG

Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space

Lung Ultrasound (LUS) Examination

Intrathecal Fentanyl DRUG

Fentanyl 15 μg will be administered in the subarachnoid space

Lung Ultrasound (LUS) Examination

Cesarean Delivery PROCEDURE

Lower segment cesarean section using the Pfannenstiel incision

Lung Ultrasound (LUS) Examination

lung ultrasound scans RADIATION

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.

Lung Ultrasound (LUS) Examination

Ultrasound Assessment of the Inferior Vena Cava OTHER

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.

Lung Ultrasound (LUS) Examination

Optic nerve sheath diameter OTHER

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.

Lung Ultrasound (LUS) Examination

ringer acetate DRUG

1000 ml ringer acetate will be administered over 2 hours.

Lung Ultrasound (LUS) Examination

Intravenous Ephedrine DRUG

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

Lung Ultrasound (LUS) Examination

Intravenous Syntocinon DRUG

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

Lung Ultrasound (LUS) Examination

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: female
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• Singleton pregnancy.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University

Al Mansurah, DK, 050, Egypt

Location

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Anesthesia, Spinal; Cesarean Section

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Delivery, Obstetric; Obstetric Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Aboelnour E Aboelnour, MD

  Professor of Anesthesia and Surgical Intensive care,

  STUDY CHAIR

• Hanaa A Elbendary, MD

  Assistant Professor, MD anesthesia Department, Faculty of Medicine, Mansoura University, Egypt.

  STUDY DIRECTOR

• Marwa L Abdo, MD

  Lecturer of Anesthesia and Surgical Intensive care,

  STUDY DIRECTOR

• Sherine A Bakrey, MD

  Lecturer of Anesthesia and Surgical Intensive care

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 1, 2020
• Study Start: June 1, 2020
• Primary Completion: August 1, 2021
• Study Completion: December 1, 2021
• Last Updated: November 13, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will be available following publication for life-long.
• Access Criteria: the data will be accessible to the investigators .and the PRS administrators with hiding the identifiers for the patients

Locations

EG (1)