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

Summary

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

Conditions

• Pre-Eclampsia
• Cesarean 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

Sponsors & Collaborators

• Mansoura University

  lead OTHER

Principal Investigators

• Mohamed M Tawfik, MD · Mansoura University Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

40 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-08-19

Primary Completion

2021-07-15

Completion

2021-07-15

Countries

• Egypt

Study Locations