Cesarean SectionNCT07689825
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
An observational study of Cesarean Section, run by Peking University Shenzhen Hospital at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Section
- What is being tested?
- Standard clinical spinal anesthesia and routine intraoperative monitoring
- Type of treatment
- Surgery or procedure
- How many people
- 145 participants
- Where
- 1 siteChina
- Study dates
- 13 Jul 2026to 1 Jul 2027
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section.
Who may be able to join
- Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section.
- Informed consent was obtained from all participants.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Standard clinical spinal anesthesia and routine intraoperative monitoring
- Keywords
- cesarean section, Post-Spinal Anesthesia Hypotension, Risk Prediction Model, Multimodal Medical Data, Perioperative Monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard clinical spinal anesthesia and routine intraoperative monitoringProcedure or surgery
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of hypotension
Hypotension was defined as a mean arterial pressure (MAP) < 65 mmHg.
Measured: from spinal anesthesia induction to fetal delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2026
- Study start13 Jul 2026 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean SectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Peking University Shenzhen Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07689825
- Sponsor's protocol ID
- 2026-158
- Status last verified
- Jul 2026
- First submitted
- 1 Jul 2026
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07689825
- Acronym / sponsor ID
- 2026-158
- Conditions
- Cesarean Section
- Keywords
- cesarean section, Post-Spinal Anesthesia Hypotension, Risk Prediction Model, Multimodal Medical Data, Perioperative Monitoring
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Peking University Shenzhen HospitalUniversity, hospital or other
- Study start
- 13 Jul 2026 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 8 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section.
Key inclusion criteria (2 listed)
- Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section.
- Informed consent was obtained from all participants.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard clinical spinal anesthesia and routine intraoperative monitoringAll 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. | Procedure or surgery | – |
Primary outcome
Incidence of hypotension
Time frame: from spinal anesthesia induction to fetal delivery
Hypotension was defined as a mean arterial pressure (MAP) < 65 mmHg.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Cesarean Section
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Lateral QL Block vs Intrathecal Morphine for Cesarean Section
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Sustained Cord Circulation at Emergency Cesarean Section
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Adding Dexmedetomidine or Clonidine to Spinal Anesthesia for Cesarean Delivery
Cesarean Delivery, Cesarean Delivery; Neuraxial Opioids
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Reducing Chronic Pain Following Cesarean Delivery
Chronic Pain, Cesarean Section Complications
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Section, run by Peking University Shenzhen Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingpin Tang (+86 18075996295, 1070136965@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of hypotension (time frame: from spinal anesthesia induction to fetal delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.