Predictors of Pulmonary Edema in Severe Preeclampsia

NCT05095974 | Unknown

• 1 other identifier: pulmonary edema
• Study Type: observational
• Target: 58
• Locations: 0 countries
• Sites: N/A

Brief Summary

Pre-eclampsia is a multisystem major cardiovascular disease of pregnancy with hypertension its main clinical manifestation. Acute pulmonary edema, which signifies severe disease, is a leading cause of death in women with pre-eclampsia, and is a frequent cause for admission to an intensive care unit

Conditions

Pulmonary Edema

Outcome Measures

Primary Outcomes (1)

• detection of pulmonary edema

  number of patients that will have pulmonary edema assessed by echo comet score by lung ultrasound (the sum of B-lines if yield more than 280 denoting extravascular fluid in the lung

  4 days

Secondary Outcomes (2)

• Echocardiography

  4 days

• Thoracic fluid content

  4 days

Study Arms (2)

A (main group)

29 Consecutive patients with a singleton pregnancy complicated by severe PE will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device

Device: ultrasonography; Device: echocardiography; Device: thoracic electrical bioimpedence

B (control group)

29 Consecutive healthy patients with a singleton pregnancy (control group) will be included in the study at hospital admission. Assessment will be done by lung ultrasound , echocardiography and thoracic bioimpedence device

Device: ultrasonography; Device: echocardiography; Device: thoracic electrical bioimpedence

Interventions

ultrasonography DEVICE

Ultrasound assessment will performed with parturient in the supine position using Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz). A C60x 5-2 MHz convex transducer will used for lung ultrasound (Mindray device (DC-N6, with a phased array transducer, model P4-2, 3-6 MHz).The Echo Comet Score (ECS) will obtained by the 28-rib interspaces technique dividing the chest wall in 12 areas on the left side (from the second to the fourth intercostal space) and 16 (from the second to the fifth intercostal space) on the right anterior and lateral hemithorax.

A (main group); B (control group)

echocardiography DEVICE

MHz cardiac transducer for echocardiography with two-dimensional, M-mode, color-flow, continuous, pulsed wave and tissue Doppler imaging.

A (main group); B (control group)

thoracic electrical bioimpedence DEVICE

EC ICONR monitor (Osypka Medical, Inc., La Jolla, California and Berlin) will be applied to the patients through four ECG electrodes. The electrodes will be placed over the bare skin of patients at the following sites: (1) on the left neck below the ear; (2) directly superior to the midpoint of the left clavicle; (3) along the left mid-axillary line at the level of the xiphoid process; (4) two-inches caudad from the third electrode.

Also known as: electrical cardiometry

A (main group); B (control group)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

After obtaining approval from the Medical Research Ethics Committee Faculty of medicine, Assiut University, Assiut, Egypt, this study will be done in ICU in Assiut University Woman Health Hospital . Written informed consents will be obtained from all participants, after reading the patient information sheet and describing the procedure to the participants

You may qualify if:

• Pregnant women with one or more of the following:
• new-onset cerebral or visual disturbances
• thrombocytopenia (platelet count \<100 000/mL)
• elevated liver enzymes (transaminases) to twice the normal upper limit;
• severe persistent pain in the right upper or middle upper abdomen that does not respond to medication and is not explained by another condition
• renal insufficiency (serum creatinine \>97 μmol/L), or a doubling of serum creatinine concentration in the absence of other renal disease
• systolic blood pressure ≥160mmHg or diastolic blood pressure ≥110mmHg on more than one occasion at least 4 h apart while the patient is on bed rest (unless antihypertensive therapy had been initiated before this time).

You may not qualify if:

• Age below 18 yr
• SP during the postpartum period
• refusal to participate to the study.
• history of cardiac or respiratory disease
• patients with clinical manifestations of pulmonary edema

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Conditions

Pulmonary Edema

Interventions

Ultrasonography; Echocardiography

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Cardiac Imaging Techniques; Heart Function Tests; Diagnostic Techniques, Cardiovascular

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assisstant lecturer of anesthesia and intensive care

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 27, 2021
• Study Start: October 30, 2021
• Primary Completion: October 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 27, 2021

Record last verified: 2021-09