Clinical trial NCT03252496: Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery
Official title: Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pre-Eclampsia
Cesarean Section
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2017-08-17
Enrollment: 140
Sex: FEMALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study will compare between combination of colloids/crystalloids and crystalloids in women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia

Detailed description: This randomized, controlled, double blind study will be conducted on women with preeclampsia with singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Immediately, after spinal anesthesia administration, patients will receive either 250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes (Combination group) or 250 mL crystalloid over 5 minutes followed by 500 mL over 55 minutes then 250 mL over 60 minutes (Crystalloid group). The studied maternal outcomes will be the urine output, ephedrine requirement, incidence of hypotension, inferior vena cava diameters, nausea/vomiting and bradycardia. Neonatal Apgar scores will be recorded at 1 and 5 minutes post-delivery.

Eligibility criteria: Inclusion Criteria:

* Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick
* Singleton pregnancy
* Elective cesarean delivery under spinal anesthesia

Exclusion Criteria:

* Height \<150 cm
* Weight \<60 kg
* Body mass index ≥45 kg/m2
* Women presenting in labor
* Contraindications to spinal anesthesia (increased intracranial pressure or local skin infection)
* Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
* Preoperative administration of intravenous hydralazine or magnesium sulphate
* Hemoglobin \<10 gm/dL
* International Normalized Ratio \>1.3
* Platelet count \<100,000 /mm3
* Preoperative serum creatinine \>1.1 mg/dL

Primary outcomes:
measure: Total urine output at 2 hours post-spinal
timeFrame: 2 hours after intrathecal injection
Secondary outcomes:
measure: Urine output at 1 hour post-spinal
timeFrame: 1 hour after intrathecal injection
measure: Incidence of oliguria
timeFrame: 2 hours after intrathecal injection
measure: Total ephedrine dose
timeFrame: Intraoperative
measure: Pre-delivery ephedrine dose
timeFrame: From intrathecal injection until delivery
measure: Number of patients requiring ephedrine
timeFrame: Intraoperative
measure: Number of patients requiring ephedrine pre-delivery
timeFrame: From intrathecal injection until delivery
measure: Incidence of nausea and/or vomiting
timeFrame: Intraoperative
measure: Incidence of bradycardia
timeFrame: Intraoperative
measure: Maximum and minimum inferior vena cava diameters
timeFrame: Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal
measure: Inferior vena cava collapsibility index
timeFrame: Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal
measure: Neonatal Apgar score
timeFrame: At 1 and 5 minutes after delivery
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Department of Anesthesia, Mansoura University Hospitals
state: Dakahlia
Study officials:
affiliation: Mansoura University Hospital
name: Mohamed M Tawfik, MD
role: PRINCIPAL_INVESTIGATOR
References: