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 | Not Yet Recruiting

• 1 other identifier: 2026-158
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cesarean Section

Keywords

cesarean section; Post-Spinal Anesthesia Hypotension; Risk Prediction Model; Multimodal Medical Data; Perioperative Monitoring

Outcome Measures

Primary Outcomes (1)

• Incidence of hypotension

  Hypotension was defined as a mean arterial pressure (MAP) \< 65 mmHg.

  from spinal anesthesia induction to fetal delivery

Interventions

Standard clinical spinal anesthesia and routine intraoperative monitoring PROCEDURE

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.

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section.

You may qualify if:

• Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section.
• Informed consent was obtained from all participants.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University Shenzhen Hospital: lead

Study Sites (1)

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

Location

Central Study Contacts

Lingpin Tang

CONTACT

+86 18075996295; 1070136965@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2026
• First Posted: July 8, 2026
• Study Start: July 13, 2026
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): July 1, 2027
• Last Updated: July 27, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)