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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06151496
Other study ID # Yi Chen-2024-2
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date December 1, 2024
Est. completion date December 31, 2025

Study information

Verified date November 2023
Source General Hospital of Ningxia Medical University
Contact Yi Chen, M.D.
Phone +86-0951-6743252
Email czzyxgp@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.


Description:

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. The 2016 ASA guidelines for obstetric anesthesia suggest avoiding hypotension following spinal anesthesia in women and emphasize the use of vasopressors, specifically alpha-receptor agonists, as the preferred strategy to prevent and manage post-spinal anesthesia hypotension. The 2018 International Consensus in the United Kingdom and Northern Ireland recommends maintaining maternal systolic blood pressure above 90% of the baseline value following lumbar anesthesia, while avoiding dropping below 80% of the baseline value. Currently, the threshold for maintaining blood pressure above 80% of the baseline value is widely adopted as a standard; however, limited evidence supports the advantage of sustaining maternal blood pressure above 90% of the baseline value. The objective of this study is to investigate the impact of varying maternal blood pressure maintenance targets on maternal hemodynamics following cesarean section.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 300
Est. completion date December 31, 2025
Est. primary completion date December 31, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 45 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.
a-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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
General Hospital of Ningxia Medical University

Outcome

Type Measure Description Time frame Safety issue
Primary Cardiac output Monitoring data 1-15 minutes after spinal anesthesia.
Primary Cardiac index Monitoring data 1-15 minutes after spinal anesthesia.
Primary Stroke volume variation Monitoring data 1-15 minutes after spinal anesthesia.
Primary Peripheral vascular resistance Monitoring data 1-15 minutes after spinal anesthesia.
Secondary The incidence of post-spinal anesthesia hypotension Systolic blood pressure (SBP) < 80% of the baseline 1-15 minutes after spinal anesthesia.
Secondary The incidence of severe post-spinal anesthesia hypotension. Systolic blood pressure (SBP) < 60% of the baseline. 1-15 minutes after spinal anesthesia.
Secondary The incidence of bradycardia. Heart rate < 60 beats/min. 1-15 minutes after spinal anesthesia.
Secondary The incidence of nausea and vomiting. Presence of nausea and vomiting in patients after spinal anesthesia 1-15 minutes after spinal anesthesia.
Secondary The incidence of hypertension. Systolic blood pressure (SBP) >120% of the baseline. 1-15 minutes after spinal anesthesia.
Secondary pH From umbilical arterial blood gases. Immediately after delivery
Secondary Base excess From umbilical arterial blood gases. Immediately after delivery
Secondary Partial pressure of oxygen (PO2) From umbilical arterial blood gases. Immediately after delivery
Secondary APGAR score A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best) 1 min after delivery
Secondary APGAR score A= Appearance P=Pulse G=Grimace A=Attitude R=Respiration; 0(Worst)-10(Best) 5 min after delivery
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