Continuous Fetal Heart Beat Monitor and Analysis After Spinal AnesthesiaNCT05776186
Fetal Heart Rate Pattern After Spinal Anesthesia for Scheduled Uncomplicated Cesarean Section
An observational study of Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
Trial summary
Spinal anesthesia may cause sympathetic blockade which decrease peripheral vascular resistance and bradycardia and then hypotension. Maternal hypotension could cause immediate fetus heart beat (FHB) deceleration and postpartum acidosis. Read more about this study
- Who is it for?
- Ages 20 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia
- What is being tested?
- Spinal anesthesia with heavy bupivacaine
- How many people
- 50 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Nov 2022to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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 20 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women for gestational age above 36 weeks
Who may be able to join
- Age above 20 years
- Singleton
- Gestational age above 36 weeks
- Scheduled Cesarean section at VGHTC
- Eligible for spinal anesthesia
- Inform consent
Who cannot join
- ASA > 3
- Prenatal examination reveal suspect neonatal congenital heart disease, heart failure, arrythymia or hydrops fetalis which could affect fetal heart beat
- Regular uterine contraction, premature rupture of membrane or vaginal bleeding before scheduled C/S on prenatal clinic
- Anticipate vaginal delivery initially but shift to C/S for prolong labor, FHB deceleration or other reason
- Patients cannot make decision for language barrier, education condition or phsycological disease
- Register in other study already
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung
Szu-Ling Chang, M.D., 886-4-23592525 ext. 4101, irbtc@vghtc.gov.tw
About this study
Official title: Fetal Heart Rate Pattern Before, During, and After Spinal Anesthesia for Scheduled Uncomplicated Cesarean Section
Spinal anesthesia may cause sympathetic blockade which decrease peripheral vascular resistance and bradycardia and then hypotension. Maternal hypotension could cause immediate fetus heart beat (FHB) deceleration and postpartum acidosis. Both intravenous hydration or vasopressor during hypotension could prevent maternal hypotension efficiently. Although there were many articles discussion about maternal hypotension and fetal heart rate variation during epidural labor analgesia, the studies about FHB variation during spinal anesthesia is not much. In one literature in 1960, if maternal blood pressure below 60-80 mmHg, FHB deceleration could happen in 5 minutes. In modern medical management, FHB change during and after spinal anesthesia is an interesting topic. The most relevant study was published by NTUH in 2015, which transformed EKG signal to possible FHB change.
The parturient will have FHB recording for 20 minutes in the day before operation. On the operation day, after proper position by the anesthetic staff (lateral position or sitting position), spinal anesthesia will performed by obstetric anesthesiologist and the lying down for supine position. Before the baby was delivered by cesarean section no FHB will be monitored. The aim of the study is continuous FHB monitor and analysis after spinal anesthesia for 5-10 minutes to improve fetal physiology knowledge and providing basic information for future study.
- Being tested
- Spinal anesthesia with heavy bupivacaine
- Keywords
- cesarean section; spinal anesthesia ; fetal heart beat
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anesthesia with heavy bupivacaineDrug
Spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Before spinal anesthesia | Before spinal anesthesia with heavy bupivacaine 12.5 mg is administrated. Receives: Drug: Spinal anesthesia with heavy bupivacaine | |
| After spinal anesthesia | After spinal anesthesia with heavy bupivacaine 12.5 mg is administrated. Receives: Drug: Spinal anesthesia with heavy bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fetal heart rate variability
Fetal heart rate deceleration (normal > 100 beats per minute)
Measured: 5 minutes after spinal anesthesia
Secondary outcomes (4)
Neonatal outcome
APGAR score_1 minute, APGAR score_5 minute ( APGAR score: 0-10 points)
Measured: 1 minute and 5 minutes after delivery
Neonatal intensive care rate
NICU admission rate
Measured: baseline (admission)
Umbilical vein analysis
Umbilical vein blood gas analysis, including pH, O2, CO2, HgB, electrolyte
Measured: within 5 minutes after delivery
Maternal pain score
Visual analog scale ( VAS score 0-10)
Measured: 0, 8, 24 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 posted20 Mar 2023
- Study start29 Nov 2022
- Primary completion13 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Continuous Fetal Heart Beat Monitor and Analysis After Spinal AnesthesiaStudies of the same condition, open and under way.
- More trials run by Taichung Veterans General HospitalThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taichung Veterans General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05776186
- Sponsor's protocol ID
- CF22379A
- Status last verified
- Mar 2023
- First submitted
- 2 Dec 2022
- Last updated
- 20 Mar 2023
- Results posted
- 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 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Heart Rate Pattern Before, During, and After Spinal Anesthesia for Scheduled Uncomplicated Cesarean Section
- ClinicalTrials.gov ID
- NCT05776186
- Acronym / sponsor ID
- CF22379A
- Keywords
- cesarean section; spinal anesthesia ; fetal heart beat
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Taichung Veterans General HospitalUniversity, hospital or other
- Study start
- 29 Nov 2022 (actual)
- Primary completion
- 13 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 20 Mar 2023 (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 may cause sympathetic blockade which decrease peripheral vascular resistance and bradycardia and then hypotension. Maternal hypotension could cause immediate fetus heart beat (FHB) deceleration and postpartum acidosis. Both intravenous hydration or vasopressor during hypotension could prevent maternal hypotension efficiently. Although there were many articles discussion about maternal hypotension and fetal heart rate variation during epidural labor analgesia, the studies about FHB variation during spinal anesthesia is not much. In one literature in 1960, if maternal blood pressure below 60-80 mmHg, FHB deceleration could happen in 5 minutes. In modern medical management, FHB change during and after spinal anesthesia is an interesting topic. The most relevant study was published by NTUH in 2015, which transformed EKG signal to possible FHB change.
The parturient will have FHB recording for 20 minutes in the day before operation. On the operation day, after proper position by the anesthetic staff (lateral position or sitting position), spinal anesthesia will performed by obstetric anesthesiologist and the lying down for supine position. Before the baby was delivered by cesarean section no FHB will be monitored. The aim of the study is continuous FHB monitor and analysis after spinal anesthesia for 5-10 minutes to improve fetal physiology knowledge and providing basic information for future study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Before spinal anesthesia | – | Drug: Spinal anesthesia with heavy bupivacaineBefore spinal anesthesia with heavy bupivacaine 12.5 mg is administrated. |
| After spinal anesthesia | – | Drug: Spinal anesthesia with heavy bupivacaineAfter spinal anesthesia with heavy bupivacaine 12.5 mg is administrated. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women for gestational age above 36 weeks
Key inclusion criteria (6 listed)
- Age above 20 years
- Singleton
- Gestational age above 36 weeks
- Scheduled Cesarean section at VGHTC
- Eligible for spinal anesthesia
Key exclusion criteria (6 listed)
- ASA > 3
- Prenatal examination reveal suspect neonatal congenital heart disease, heart failure, arrythymia or hydrops fetalis which could affect fetal heart beat
- Regular uterine contraction, premature rupture of membrane or vaginal bleeding before scheduled C/S on prenatal clinic
- Anticipate vaginal delivery initially but shift to C/S for prolong labor, FHB deceleration or other reason
- Patients cannot make decision for language barrier, education condition or phsycological disease
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 |
|---|---|---|
| Spinal anesthesia with heavy bupivacaineSpinal anesthesia | Drug | After spinal anesthesia, Before spinal anesthesia |
Primary outcome
Fetal heart rate variability
Time frame: 5 minutes after spinal anesthesia
Fetal heart rate deceleration (normal > 100 beats per minute)
4 secondary outcomes
Neonatal outcome
Time frame: 1 minute and 5 minutes after delivery
Neonatal intensive care rate
Time frame: baseline (admission)
Umbilical vein analysis
Time frame: within 5 minutes after delivery
Maternal pain score
Time frame: 0, 8, 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Mar 2023.
- Individual participant dataSharing planned: No
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. This study is not recruiting at the moment.
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 Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia, run by Taichung Veterans General Hospital at 1 site in Taiwan.
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 6 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: status not confirmed, as of the sponsor's last update on 20 Mar 2023. 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 Taiwan. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fetal heart rate variability (time frame: 5 minutes after spinal anesthesia). 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 20 Mar 2023.