NCT03252496

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

Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Mansoura University · Academic / Other
• Sex: Female
• Age: 19 Years – 40 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pre-Eclampsia
• Cesarean Section

Interventions

Type	Name	Description
PROCEDURE	Spinal Anesthesia	Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
DRUG	Intrathecal Bupivacaine	Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
DRUG	Intrathecal Fentanyl	Fentanyl 15 μg will be administered in the subarachnoid space
PROCEDURE	Cesarean Delivery	Lower segment cesarean section using the Pfannenstiel incision
RADIATION	Ultrasound Assessment of the Inferior Vena Cava	The inferior vena cava largest and smallest diameters will be measured proximal to the opening of the hepatic veins in the longitudinal axis with the M-mode using a 8-2 MHz curved array ultrasound probe placed longitudinally in the subcostal region
DRUG	250 mL Colloid over 5 minutes	6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
DRUG	250 mL Crystalloid over 5 minutes	Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
DRUG	500 mL Crystalloid over 55 minutes	Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
DRUG	250 mL Colloid over 60 minutes	After 60 minutes of intrathecal injection, 6% hydroxyethyl starch 130/0.4 in 0.9% sodium chloride (voluven®) 250 mL will be administered over 60 minutes
DRUG	250 mL Crystalloid over 60 minutes	After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes
DRUG	Intravenous Ephedrine	Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
DRUG	Intravenous Syntocinon	Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution

Timeline

• Start date: 2017-08-19
• Primary completion: 2021-07-15
• Completion: 2021-07-15
• First posted: 2017-08-17
• Last updated: 2021-09-05

Locations

1 site across 1 country: Egypt