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Clinical Trials in China / NCT07689825
Starting soon Observational

Development of a Risk Prediction Model for Post-Spinal Anesthesia Hypotension During Cesarean Delivery Using Heart Rate, Blood Pressure, Perfusion Index, ECG Waveforms, and SpO₂ Waveforms

NCT07689825 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Shenzhen Hospital
Phase
Observational
Started
2026-07-13
Last updated
2026-07-27

Condition(s) studied

Cesarean Section

Investigational drug(s) / intervention(s)

Standard clinical spinal anesthesia and routine intraoperative monitoring

Standard clinical spinal anesthesia and routine intraoperative monitoring: All participants receive routine clinical spinal anesthesia, standard surgical operation and conventional vital sign monitoring without additional experimental intervention. No new drugs, devices or invasive operations are applied in this study.

Study summary

Spinal anesthesia is the preferred anesthetic technique for patients undergoing cesarean section. Compared with general anesthesia, spinal anesthesia offers multiple advantages. However, a common adverse effect of this technique is hypotension following spinal anesthesia, which is induced by sympathetic blockade and has an incidence rate as high as 70%. Hypotension can lead to maternal nausea and vomiting, reduced fetal Apgar scores, and acidosis, exerting adverse effects on both the mother and the fetus. Furthermore, prolonged duration of hypotension may adversely impact the fetal neurological prognosis. Therefore, predicting which patients are at high risk for developing hypotension facilitates the implementation of preventive measures-such as the administration of vasoactive agents and intensified monitoring through frequent blood pressure measurements-to improve clinical outcomes in these high-risk patients.

Patients undergoing cesarean section who met the inclusion criteria were prospectively observed. A standardized anesthesia protocol was uniformly applied to investigate the incidence of hypotension following spinal anesthesia. Based on dynamic changes in preoperative and intraoperative heart rate, blood pressure, perfusion index, and waveform characteristics of electrocardiography and pulse oximetry, a prognostic model was developed to predict the occurrence of hypotension after spinal anesthesia.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
50 Years
Healthy volunteers
No
Inclusion Criteria: * Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section. * Informed consent was obtained from all participants. Exclusion Criteria: * Emergency cesarean sections or cases requiring general anesthesia. * Maternal age \< 18 years. * Major obstetric complications (e.g., placenta previa, gestational hypertension, preeclampsia) or significant cardiovascular/cerebrovascular diseases. * Body Mass Index (BMI) ≥ 36 kg/m². * Gestational age \< 36 weeks or \> 41 weeks. * Contraindications to neuraxial anesthesia. * Refusal to participate.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University Shenzhen Hospital Shenzhen Guangdong

More Peking University Shenzhen Hospital trials in China

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07689825 on ClinicalTrials.gov ↗ ← All trials in China