Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery

Mansoura University

Status: Completed

Conditions: Cesarean Section; Pre-Eclampsia

Treatments: Drug: 250 mL Colloid over 60 minutes; Procedure: Cesarean Delivery; Drug: Intravenous Syntocinon; Drug: Intrathecal Bupivacaine; Drug: 250 mL Colloid over 5 minutes; Drug: 250 mL Crystalloid over 5 minutes; Procedure: Spinal Anesthesia; Radiation: Ultrasound Assessment of the Inferior Vena Cava; Drug: 500 mL Crystalloid over 55 minutes; Drug: 250 mL Crystalloid over 60 minutes; Drug: Intravenous Ephedrine; Drug: Intrathecal Fentanyl

Study type: Interventional

Funder types: Other

Identifiers

NCT03252496

R/17.06.79

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 patients

Sex: Female

Ages: 19 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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140 participants in 2 patient groups

Combination

Experimental group

Description:

250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.

Treatment:

Drug: Intravenous Syntocinon

Drug: 250 mL Colloid over 60 minutes

Radiation: Ultrasound Assessment of the Inferior Vena Cava

Drug: 250 mL Colloid over 5 minutes

Drug: Intrathecal Fentanyl

Drug: Intrathecal Bupivacaine

Drug: 500 mL Crystalloid over 55 minutes

Procedure: Cesarean Delivery

Drug: Intravenous Ephedrine

Procedure: Spinal Anesthesia

Crystalloid

Active Comparator group

Description:

250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.

Treatment:

Drug: Intravenous Syntocinon

Radiation: Ultrasound Assessment of the Inferior Vena Cava

Drug: 250 mL Crystalloid over 5 minutes

Drug: 250 mL Crystalloid over 60 minutes

Drug: Intrathecal Fentanyl

Drug: Intrathecal Bupivacaine

Drug: 500 mL Crystalloid over 55 minutes

Procedure: Cesarean Delivery

Drug: Intravenous Ephedrine

Procedure: Spinal Anesthesia