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Clinical trial

Intensive Versus Standard Treatment for Spinal Anesthesia-induced Hypotension on Maternal Hemodynamics During Cesarean Section: A Multicenter, Prospective, Single-blind, Randomized, Controlled Trial

ID
Name
Yi Chen-2024-2
Description
The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.
Trial arms
Trial start
2024-12-01
Estimated PCD
2025-12-31
Trial end
2025-12-31
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
300
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 ≥37 weeks * American Society of Anesthesiologists physical status classification I to II * Scheduled for cesarean section under spinal anesthesia Exclusion Criteria: * Body height \< 150 cm * Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2 * Eclampsia or chronic hypertension or baseline blood pressure ≥180 mmHg * 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': 300, 'type': 'ESTIMATED'}}
Updated at
2023-11-30

1 organization

2 products

1 indication

Organization
General Hospital of Ningxia Medical University
Product
Alpha-Agonist
Indication
Outcome
Product
α-adrenergic receptor agonist