Preeclampsia Clinical Trial
Official title:
Ultrasonography for Fluid Assessment in Parturients With Preeclampsia Undergoing Elective Cesarean Section Under Spinal Anesthesia
NCT number | NCT04370847 |
Other study ID # | MD.19.10.235 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | June 1, 2020 |
Est. completion date | December 1, 2021 |
Verified date | December 2021 |
Source | Mansoura University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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)
Status | Completed |
Enrollment | 100 |
Est. completion date | December 1, 2021 |
Est. primary completion date | August 1, 2021 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 19 Years to 45 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Egypt | Mansoura University | Mansoura | DK |
Lead Sponsor | Collaborator |
---|---|
Mansoura University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Urine output | total urine output at 2 hours after spinal anesthesia | For 2 hours after spinal anesthesia | |
Secondary | Oliguria | Incidence of oliguria defined as a total urine output <60 mL/hr | For 2 hours after spinal anesthesia | |
Secondary | Ephedrine use | total ephedrine dose | Intraoperative | |
Secondary | Intraoperative bradycardia | Incidence of bradycardia (Heart rate <50 beats/minute) | Intraoperative | |
Secondary | Incidence of nausea and vomiting. | Incidence of nausea and/or vomiting as reported by the patient | Intraoperative | |
Secondary | Difference between overall number of b lines | difference between overall number of b lines preoperative(baseline) and at 1 hour after spinal anesthesia. | baseline and 1hour post spinal | |
Secondary | Inferior Vena Caval Diameters | Maximum, minimum inferior vena cava diameters and inferior vena cava collapsibility index changes over time. | Baseline, and at 1 and 2 hours post-spinal | |
Secondary | Difference between optic nerve sheath diameter | optic nerve sheath diameter changes over time. | baseline,at 1hour and at 2 hours of spinal anesthesia. | |
Secondary | Neonatal Apgar score | neonatal Apgar score to assess neonatal wellbeing at 5 min after delivery | 5 min after delivery |
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