PregnancyATHNCDNCT07852624
Comparison of Different Anesthetic Techniques on Hearing Outcomes in Neonates After Cesarean Delivery
A study testing Combined spinal-epidural anesthesia and General Anesthesia (GA) in people with Pregnancy and Neonatal Hearing Function, run by Second Affiliated Hospital of Wenzhou Medical University at 1 site in China.
Trial summary
This is a single-center, prospective, single-blind randomized controlled trial. The investigators plan to recruit 144 pregnant women scheduled for cesarean delivery. Participants will be randomly assigned to receive either combined spinal-epidural anesthesia (CSEA) or general anesthesia (GA). Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Pregnancy, Neonatal Hearing Function
- What is being tested?
- Combined spinal-epidural anesthesia and General Anesthesia (GA)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2025to 25 Oct 2026
- Phase
- Interventional
- 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 35 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
None listed.
Who cannot join
- Refusal to participate;
- Contraindications to neuraxial anesthesia;
- Severe comorbidities, including hypertensive disorders of pregnancy, cardiovascular disease, hepatic or renal dysfunction, or coagulation abnormalities;
- History of psychiatric disorders, severe anxiety or depression, or chronic preoperative use of sedative or analgesic medications;
- Neonatal hyperbilirubinemia or birth weight <2,500 g;
- Anticipated intraoperative conditions that would prevent completion of the study per the prespecified protocol.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, 325000
Mingpin Hu, MD, +860577-85676442, Hmp2008mz@163.com
About this study
This is a single-center, prospective, single-blind randomized controlled trial. The investigators plan to recruit 144 pregnant women scheduled for cesarean delivery. Participants will be randomly assigned to receive either combined spinal-epidural anesthesia (CSEA) or general anesthesia (GA). The study aims to compare the effects of these two anesthetic techniques on neonatal hearing after cesarean delivery. The investigators will collect neonatal transient evoked otoacoustic emission (TEOAE) screening results and conduct follow-up hearing assessments at 3-6 months of age for infants who fail repeat screening. The investigators will also record maternal intraoperative hemodynamic changes, the interval from anesthesia initiation to neonatal delivery, neonatal Apgar scores at 1 and 5 minutes, and maternal postoperative pain scores at multiple time points.
Read the detailed description
This is a single-center, prospective, single-blind, parallel-group randomized controlled trial. A total of 144 eligible parturients undergoing cesarean section will be enrolled and randomly allocated in a 1:1 ratio to the combined spinal-epidural anesthesia (CSEA) group or general anesthesia (GA) group. An independent statistician will generate the randomization sequence using a computerized random number table. Allocation concealment will be maintained using sealed, opaque, sequentially numbered envelopes, which will be opened by an independent coordinator after enrollment.
Participants will not be informed of their assigned anesthesia group. Anesthesia providers and surgical teams will be aware of group assignment. All outcome assessors, including personnel recording hemodynamic data, assessing Apgar scores, performing TEOAE hearing screening, and collecting postoperative VAS pain scores and adverse-event data, will remain blinded to group allocation to reduce assessment bias.
The investigators will compare maternal intraoperative hemodynamic changes and record the interval from anesthesia administration to neonatal delivery. Neonatal Apgar scores will be recorded at 1 and 5 minutes. Maternal postoperative Visual Analogue Scale (VAS) pain scores will be collected at 1, 6, 12, 24, and 48 hours after surgery. Neonatal hearing outcomes will include initial and repeat transient evoked otoacoustic emission (TEOAE) screening results. Infants who fail repeat screening will undergo further hearing assessment at 3-6 months of age to identify hearing loss.
- Conditions
- Pregnancy, Neonatal Hearing Function
- Being tested
- Combined spinal-epidural anesthesia, General Anesthesia (GA)
- Keywords
- Cesarean section, Combined spinal-epidural anesthesia, General anesthesia, Neonatal hearing, Transient evoked otoacoustic emission
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combined spinal-epidural anesthesiaProcedure or surgery
Combined spinal-epidural anesthesia is administered for elective cesarean section according to the study protocol
General Anesthesia (GA)Procedure or surgery
General anesthesia performed for cesarean delivery
| Study group | Role | What they receive |
|---|---|---|
| Combined Spinal-Epidural Anesthesia Group (CSEA Group) | Active comparator | Participants receive combined spinal-epidural anesthesia for elective cesarean section. Intraoperative hemodynamic parameters, time from anesthesia initiation to fetal delivery, neonatal Apgar scores, postoperative VAS pain scores and neonatal TEOAE hearing screening results will be collected. Receives: Procedure: Combined spinal-epidural anesthesia |
| General Anesthesia Group (GA Group) | Active comparator | Participants receive general anesthesia for elective cesarean section. The same set of maternal and neonatal indicators will be collected and compared with the CSEA group. Receives: Procedure: General Anesthesia (GA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. Neonatal hearing screening pass rate by transient evoked otoacoustic emission (TEOAE)
The pass rate of neonatal transient evoked otoacoustic emission (TEOAE) hearing screening within 72 hours after birth.
Measured: Within 72 hours after delivery
Secondary outcomes (3)
Maternal intraoperative hemodynamic changes
Changes in maternal blood pressure and heart rate during cesarean section.
Measured: during surgery
Neonatal Apgar scores
Apgar scores will be assessed at 1 and 5 minutes after birth. The Apgar score evaluates five components: Appearance, Pulse, Grimace, Activity, and Respiration. The total score ranges from 0 to 10, with higher scores indicating better neonatal condition and a better outcome.
Measured: 1 minute and 5 minutes after birth
Postoperative maternal VAS pain score
Postoperative maternal pain intensity will be assessed using the Visual Analog Scale (VAS) at 1, 6, 12, 24, and 48 hours after cesarean delivery. The VAS ranges from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate greater pain intensity and therefore a worse outcome.
Measured: 1 hour, 6 hours, 12 hours, 24 hours and 48 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start2 Aug 2025
- Primary completion1 Jun 2026
- Study completion25 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital of Wenzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852624
- Sponsor's protocol ID
- SAHoWMU-CR2026-03-119
- Other IDs
- Y20240333 and GY20250289
- Acronym
- ATHNCD
- Status last verified
- Aug 2026
- First submitted
- 25 Sep 2026
- Last updated
- 8 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual participant data including baseline characteristics, intraoperative variables, postoperative VAS pain scores, and neonatal hearing screening results will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Different Anesthetic Techniques on Hearing Outcomes in Neonates After Cesarean Delivery
- ClinicalTrials.gov ID
- NCT07852624
- Acronym / sponsor ID
- ATHNCD / SAHoWMU-CR2026-03-119
- Conditions
- Pregnancy, Neonatal Hearing Function
- Keywords
- Cesarean section, Combined spinal-epidural anesthesia, General anesthesia, Neonatal hearing, Transient evoked otoacoustic emission
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital of Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- 2 Aug 2025 (actual)
- Primary completion
- 1 Jun 2026 (actual)
- Study completion
- 25 Oct 2026 (estimated)
- First posted
- 1 Oct 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.
This is a single-center, prospective, single-blind randomized controlled trial. The investigators plan to recruit 144 pregnant women scheduled for cesarean delivery. Participants will be randomly assigned to receive either combined spinal-epidural anesthesia (CSEA) or general anesthesia (GA). The study aims to compare the effects of these two anesthetic techniques on neonatal hearing after cesarean delivery. The investigators will collect neonatal transient evoked otoacoustic emission (TEOAE) screening results and conduct follow-up hearing assessments at 3-6 months of age for infants who fail repeat screening. The investigators will also record maternal intraoperative hemodynamic changes, the interval from anesthesia initiation to neonatal delivery, neonatal Apgar scores at 1 and 5 minutes, and maternal postoperative pain scores at multiple time points.
Detailed description
This is a single-center, prospective, single-blind, parallel-group randomized controlled trial. A total of 144 eligible parturients undergoing cesarean section will be enrolled and randomly allocated in a 1:1 ratio to the combined spinal-epidural anesthesia (CSEA) group or general anesthesia (GA) group. An independent statistician will generate the randomization sequence using a computerized random number table. Allocation concealment will be maintained using sealed, opaque, sequentially numbered envelopes, which will be opened by an independent coordinator after enrollment.
Participants will not be informed of their assigned anesthesia group. Anesthesia providers and surgical teams will be aware of group assignment. All outcome assessors, including personnel recording hemodynamic data, assessing Apgar scores, performing TEOAE hearing screening, and collecting postoperative VAS pain scores and adverse-event data, will remain blinded to group allocation to reduce assessment bias.
The investigators will compare maternal intraoperative hemodynamic changes and record the interval from anesthesia administration to neonatal delivery. Neonatal Apgar scores will be recorded at 1 and 5 minutes. Maternal postoperative Visual Analogue Scale (VAS) pain scores will be collected at 1, 6, 12, 24, and 48 hours after surgery. Neonatal hearing outcomes will include initial and repeat transient evoked otoacoustic emission (TEOAE) screening results. Infants who fail repeat screening will undergo further hearing assessment at 3-6 months of age to identify hearing loss.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Spinal-Epidural Anesthesia Group (CSEA Group) | Active comparator | Procedure: Combined spinal-epidural anesthesiaParticipants receive combined spinal-epidural anesthesia for elective cesarean section. Intraoperative hemodynamic parameters, time from anesthesia initiation to fetal delivery, neonatal Apgar scores, postoperative VAS pain scores and neonatal TEOAE hearing screening results will be collected. |
| General Anesthesia Group (GA Group) | Active comparator | Procedure: General Anesthesia (GA)Participants receive general anesthesia for elective cesarean section. The same set of maternal and neonatal indicators will be collected and compared with the CSEA group. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (6 listed)
- Refusal to participate;
- Contraindications to neuraxial anesthesia;
- Severe comorbidities, including hypertensive disorders of pregnancy, cardiovascular disease, hepatic or renal dysfunction, or coagulation abnormalities;
- History of psychiatric disorders, severe anxiety or depression, or chronic preoperative use of sedative or analgesic medications;
- Neonatal hyperbilirubinemia or birth weight <2,500 g;
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 |
|---|---|---|
| Combined spinal-epidural anesthesiaCombined spinal-epidural anesthesia is administered for elective cesarean section according to the study protocol | Procedure or surgery | Combined Spinal-Epidural Anesthesia Group (CSEA Group) |
| General Anesthesia (GA)General anesthesia performed for cesarean delivery | Procedure or surgery | General Anesthesia Group (GA Group) |
Primary outcome
1. Neonatal hearing screening pass rate by transient evoked otoacoustic emission (TEOAE)
Time frame: Within 72 hours after delivery
The pass rate of neonatal transient evoked otoacoustic emission (TEOAE) hearing screening within 72 hours after birth.
3 secondary outcomes
Maternal intraoperative hemodynamic changes
Time frame: during surgery
Neonatal Apgar scores
Time frame: 1 minute and 5 minutes after birth
Postoperative maternal VAS pain score
Time frame: 1 hour, 6 hours, 12 hours, 24 hours and 48 hours after surgery
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 8 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual participant data including baseline characteristics, intraoperative variables, postoperative VAS pain scores, and neonatal hearing screening results will be shared.
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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?
A study testing Combined spinal-epidural anesthesia and General Anesthesia (GA) in people with Pregnancy and Neonatal Hearing Function, run by Second Affiliated Hospital of Wenzhou Medical University 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 0 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 8 Oct 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 Baiping Mao, PhD (+860577-85676879, baipingmaowmu@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. Neonatal hearing screening pass rate by transient evoked otoacoustic emission (TEOAE) (time frame: Within 72 hours after 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 8 Oct 2026.