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Clinical trial

Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics in Preeclamptic Patients During Cesarean Section

ID
Name
Yi Chen-2024-6
Description
The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics in preeclamptic patients following cesarean section.
Trial arms
Trial start
2024-07-01
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Not yet recruiting
Treatment
Alpha-Agonist
The maternal systolic blood pressure was consistently maintained above 80% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Arms:
Standard group
Other names:
Vasopressors
α-adrenergic receptor agonist
The maternal systolic blood pressure was consistently maintained above 90% of the preoperative baseline value from the initiation of spinal anesthesia until fetal delivery.
Arms:
Intensive group
Other names:
Vasopressors
Size
160
Primary endpoint
Cardiac output
1-15 minutes after spinal anesthesia.
Cardiac index
1-15 minutes after spinal anesthesia.
Stroke volume variation
1-15 minutes after spinal anesthesia.
Peripheral vascular resistance
1-15 minutes after spinal anesthesia.
Eligibility criteria
Inclusion Criteria: * 18-45 years * Primipara or multipara * Singleton pregnancy ≥32 weeks * American Society of Anesthesiologists physical status classification I to III * Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: * Baseline blood pressure ≥160 mmHg * Body height \< 150 cm * Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2 * Eclampsia or chronic hypertension * Hemoglobin \< 7g/dl * Fetal distress, or known fetal developmental anomaly
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 160, 'type': 'ESTIMATED'}}
Updated at
2023-11-30

1 organization

2 products

1 indication

Organization
General Hospital of Ningxia Medical University
Product
Alpha-Agonist
Indication
Adverse Effect
Product
α-Adrenergic Receptor Agonist