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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03252496
• Other study ID #: R/17.06.79
• Status: Completed
• Phase: N/A
• Start date: August 19, 2017
• Est. completion date: July 15, 2021

Study information

• Verified date: September 2021
• Source: Mansoura University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: July 15, 2021
• Est. primary completion date: July 15, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 19 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Eclampsia
• Pre-Eclampsia

Intervention

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
• 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
• 250 mL Crystalloid over 5 minutes
Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
• 500 mL Crystalloid over 55 minutes
Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
• 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
• 250 mL Crystalloid over 60 minutes
After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes
• Intravenous Ephedrine
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
• Intravenous Syntocinon
Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution

Locations

Country	Name	City	State
Egypt	Department of Anesthesia, Mansoura University Hospitals	Mansoura	Dakahlia

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total urine output at 2 hours post-spinal		2 hours after intrathecal injection
Secondary	Urine output at 1 hour post-spinal		1 hour after intrathecal injection
Secondary	Incidence of oliguria	Total urine output at 2 hours post-spinal <60 mL	2 hours after intrathecal injection
Secondary	Total ephedrine dose		Intraoperative
Secondary	Pre-delivery ephedrine dose		From intrathecal injection until delivery
Secondary	Number of patients requiring ephedrine		Intraoperative
Secondary	Number of patients requiring ephedrine pre-delivery		From intrathecal injection until delivery
Secondary	Incidence of nausea and/or vomiting		Intraoperative
Secondary	Incidence of bradycardia	Heart rate <50 beats/minute	Intraoperative
Secondary	Maximum and minimum inferior vena cava diameters		Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal
Secondary	Inferior vena cava collapsibility index		Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal
Secondary	Neonatal Apgar score		At 1 and 5 minutes after delivery