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NCT Number: NCT07689825

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

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.

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Key information

Conditions

Age range

18 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518000, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Incidence of hypotension

    Time frame: from spinal anesthesia induction to fetal delivery

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lingpin Tang

CONTACT

[email protected]

+86 18075996295

Sponsors and collaborators

Lead sponsor

Peking University Shenzhen Hospital

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Jul 8, 2026
Registry last updated
Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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