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

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

Detailed Description
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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.

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

Conditions
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Pre-Eclampsia, Cesarean Section

Intervention / Treatment
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* Procedure: Spinal Anesthesia
* Drug: Intrathecal Bupivacaine
* Drug: Intrathecal Fentanyl
* Procedure: Cesarean Delivery
* Radiation: Ultrasound Assessment of the Inferior Vena Cava
* Drug: 250 mL Colloid over 5 minutes
* Drug: 250 mL Crystalloid over 5 minutes
* Drug: 500 mL Crystalloid over 55 minutes
* Drug: 250 mL Colloid over 60 minutes
* Drug: 250 mL Crystalloid over 60 minutes
* Drug: Intravenous Ephedrine
* Drug: Intravenous Syntocinon


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Combination<br>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. | Procedure: Spinal Anesthesia<br>* Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle<br>Drug: Intrathecal Bupivacaine<br>* Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space<br>Drug: Intrathecal Fentanyl<br>* Fentanyl 15 μg will be administered in the subarachnoid space<br>Procedure: Cesarean Delivery<br>* Lower segment cesarean section using the Pfannenstiel incision<br>Radiation: Ultrasound Assessment of the Inferior Vena Cava<br>* 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<br>Drug: 250 mL Colloid over 5 minutes<br>* 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<br>Drug: 500 mL Crystalloid over 55 minutes<br>* Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration<br>Drug: 250 mL Colloid over 60 minutes<br>* 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<br>Drug: Intravenous Ephedrine<br>* Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.<br>Drug: Intravenous Syntocinon<br>* Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution<br>|
| Active Comparator: Crystalloid<br>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. | Procedure: Spinal Anesthesia<br>* Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle<br>Drug: Intrathecal Bupivacaine<br>* Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space<br>Drug: Intrathecal Fentanyl<br>* Fentanyl 15 μg will be administered in the subarachnoid space<br>Procedure: Cesarean Delivery<br>* Lower segment cesarean section using the Pfannenstiel incision<br>Radiation: Ultrasound Assessment of the Inferior Vena Cava<br>* 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<br>Drug: 250 mL Crystalloid over 5 minutes<br>* Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection<br>Drug: 500 mL Crystalloid over 55 minutes<br>* Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration<br>Drug: 250 mL Crystalloid over 60 minutes<br>* After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes<br>Drug: Intravenous Ephedrine<br>* Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.<br>Drug: Intravenous Syntocinon<br>* Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Neonatal Apgar score |  | At 1 and 5 minutes after delivery |