Fetal Heart Rate Pattern After Spinal Anesthesia for Scheduled Uncomplicated Cesarean Section

NCT ID: NCT05776186

Last Updated: 2023-03-20

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-29
• Study Completion Date: 2023-12-31

Brief 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. 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.

Conditions

Continuous Fetal Heart Beat Monitor and Analysis After Spinal Anesthesia

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Before spinal anesthesia

Before spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.

Spinal anesthesia with heavy bupivacaine

Intervention Type: DRUG

Spinal anesthesia

After spinal anesthesia

After spinal anesthesia with heavy bupivacaine 12.5 mg is administrated.

Spinal anesthesia with heavy bupivacaine

Intervention Type: DRUG

Spinal anesthesia

Interventions

Spinal anesthesia with heavy bupivacaine

Spinal anesthesia

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age above 20 years

2. Singleton

3. Gestational age above 36 weeks

4. Scheduled Cesarean section at VGHTC

5. Eligible for spinal anesthesia

6. Inform consent

Exclusion Criteria

1. ASA > 3

2. Prenatal examination reveal suspect neonatal congenital heart disease, heart failure, arrythymia or hydrops fetalis which could affect fetal heart beat

3. Regular uterine contraction, premature rupture of membrane or vaginal bleeding before scheduled C/S on prenatal clinic

4. Anticipate vaginal delivery initially but shift to C/S for prolong labor, FHB deceleration or other reason

5. Patients cannot make decision for language barrier, education condition or phsycological disease

6. Register in other study already

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Taichung Veterans General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taichung Veterans General Hospital

Taichung, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Facility Contacts

Szu-Ling Chang, M.D.

Role: primary

irbtc@vghtc.gov.tw

886-4-23592525 ext. 4101

Other Identifiers

CF22379A

Identifier Type: -

Identifier Source: org_study_id