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

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

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Pre-Eclampsia
• Intervention / Treatment: Drug: Intrathecal Bupivacaine; Drug: Intrathecal Fentanyl; Procedure: Spinal Anesthesia; Procedure: Cesarean Delivery; Radiation: Ultrasound Assessment of the Inferior Vena Cava; Drug: 250 mL Colloid over 5 minutes; Drug: 500 mL Crystalloid over 55 minutes; Drug: 250 mL Colloid over 60 minutes; Drug: Intravenous Ephedrine; Drug: Intravenous Syntocinon; Drug: 250 mL Crystalloid over 5 minutes; Drug: 250 mL Crystalloid over 60 minutes

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.

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Dakahlia
    • Mansoura, Dakahlia, Egypt, 35511
      • Department of Anesthesia, Mansoura University Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Combination; 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.	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: Spinal Anesthesia; Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle; 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: 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: 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
ACTIVE_COMPARATOR: Crystalloid; 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.	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: Spinal Anesthesia; Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle; 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: 500 mL Crystalloid over 55 minutes; Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration; 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; Drug: 250 mL Crystalloid over 5 minutes; Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection; Drug: 250 mL Crystalloid over 60 minutes; After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Total urine output at 2 hours post-spinal	2 hours after intrathecal injection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neonatal Apgar score		At 1 and 5 minutes after delivery
Urine output at 1 hour post-spinal		1 hour after intrathecal injection
Incidence of oliguria	Total urine output at 2 hours post-spinal <60 mL	2 hours after intrathecal injection
Total ephedrine dose		Intraoperative
Pre-delivery ephedrine dose		From intrathecal injection until delivery
Number of patients requiring ephedrine		Intraoperative
Number of patients requiring ephedrine pre-delivery		From intrathecal injection until delivery
Incidence of nausea and/or vomiting		Intraoperative
Incidence of bradycardia	Heart rate <50 beats/minute	Intraoperative
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
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

Collaborators and Investigators

• Sponsor: Mansoura University

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 19, 2017
• Primary Completion (ACTUAL): July 15, 2021
• Study Completion (ACTUAL): July 15, 2021

Study Registration Dates

• First Submitted: August 14, 2017
• First Submitted That Met QC Criteria: August 15, 2017
• First Posted (ACTUAL): August 17, 2017

Study Record Updates

• Last Update Posted (ACTUAL): September 5, 2021
• Last Update Submitted That Met QC Criteria: September 3, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Local; Reproductive Control Agents; Central Nervous System Stimulants; Oxytocics; Sympathomimetics; Vasoconstrictor Agents; Fentanyl; Oxytocin; Bupivacaine; Ephedrine
• Other Study ID Numbers: R/17.06.79

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No