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

NACompletedINTERVENTIONAL
Enrollment

140

Participants

Timeline

Start Date

August 19, 2017

Primary Completion Date

July 15, 2021

Study Completion Date

July 15, 2021

Conditions
Pre-EclampsiaCesarean Section
Interventions
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

Trial Locations (1)

35511

Department of Anesthesia, Mansoura University Hospitals, Al Mansurah

All Listed Sponsors
lead

Mansoura University

OTHER

NCT03252496 - Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery | Biotech Hunter | Biotech Hunter