Pre-Eclampsia, Cesarean Section
Conditions
Brief summary
This study will compare between combination of colloids/crystalloids and crystalloids in women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia
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.
Interventions
PROCEDURESpinal Anesthesia
Performed at the L3-L4 or L4-L5 interspace using 27- or 25-gauge spinal needle
Bupivacaine 12.5 mg (2.5 mL 0.5%) will be administered in the subarachnoid space
Fentanyl 15 μg will be administered in the subarachnoid space
PROCEDURECesarean Delivery
Lower segment cesarean section using the Pfannenstiel incision
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
DRUG250 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
DRUG250 mL Crystalloid over 5 minutes
Ringer acetate 250 mL will be administered over 5 minutes starting immediately after intrathecal injection
DRUG500 mL Crystalloid over 55 minutes
Ringer acetate 500 mL will be administered over 55 minutes following colloid or crystalloid administration
DRUG250 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
DRUG250 mL Crystalloid over 60 minutes
After 60 minutes of intrathecal injection, Ringer acetate 250 mL will be administered over 60 minutes
Intravenous ephedrine 3, 5, and 10 mg will be administered when Systolic blood pressure decreases below 120, 110, and 90 mmHg, respectively.
Immediately after delivery, syntocinon 10 IU will be added to the running crystalloid solution
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total urine output at 2 hours post-spinal | 2 hours after intrathecal injection |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Urine output at 1 hour post-spinal | 1 hour after intrathecal injection | — |
| Incidence of oliguria | 2 hours after intrathecal injection | Total urine output at 2 hours post-spinal \<60 mL |
| 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 | Intraoperative | Heart rate \<50 beats/minute |
| 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 | — |
Countries
Egypt
Outcome results
None listed