Changes in Velocimetric Indices of Uterine and Umbilical Arteries Before and After Combined Spinal-epidural Analgesia in Laboring Women (PART II)

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status: Enrolling

Conditions: Labor Pain

Treatments: Device: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06655675

24-09

Details and patient eligibility

About

Combined spinal-epidural (CSE) for labor analgesia has been used for many years and is practiced commonly at our institution, especially when the patient requests immediate pain relief. CSE is not only beneficial for its faster onset of analgesia, but also it is favorable in relation to the need for rescue analgesia, urinary retention, and rate of instrumental delivery compared to the traditional epidural. Despite its beneficial effects, there is a risk of about 15-30% of developing abnormal fetal heart rate following CSE. This is self-resolving with minimal or no intervention. Although the cause of fetal bradycardia is not fully elucidated, variations in uterine artery blood flow after epidural analgesia are thought to be due to the interaction of numerous events related to blockade of sympathetic innervations, fluid administration, maternal hypotension, uterine vascular effects of sympathetic block, fluctuations in circulating catecholamines, and possibly the effect of opioids. Similar mechanism is thought to be a cause of fetal bradycardia after the CSE with its faster onset and superior block.

Maternal or fetal circulation during labor can be assessed using continuous-wave Doppler ultrasound to monitor maternal uterine artery (UtA) and fetal umbilical artery (UmA) velocity waveforms to detect changes in blood flow. The velocimetry indices mentioned above have been often used to assess the changes in the blood flow before and after the induction of epidural analgesia during labor in several studies. Although there are some studies regarding the effect of labor epidural analgesia using velocimetry indices, but there is currently no published study evaluating velocimetry indices of uterine and umbilical arteries before and after the induction of CSE. Thus, the aim of this study is to investigate the impact of CSE to maternal and fetal blood flow to evaluate the relationships.

The investigators hypothesize that both uterine artery and umbilical artery blood flow are reduced after the induction of CSE, which may be responsible for the occurrence of fetal bradycardia.

Enrollment: 54 estimated patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Written informed consent
• Term pregnant patients requesting labor analgesia
• Singleton pregnancy
• Term pregnant patients in active labor
• ASA<4
• No evidence of fetal congenital anomalies, fetal compromise or fetal decelerations prior to CSE
• Patients with and without diagnosed hypertensive disorders of pregnancy

Exclusion criteria

• Refusal to consent for the study
• Known spinal deformities
• Previous back instrumentation
• Patients with BMI>50 kg/㎡ due to anticipated technical challenges in Doppler studies

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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54 participants in 2 patient groups

Ultrasound - patients without hypertensive disorders of pregnancy

Experimental group

Description:

Ultrasound will be used to measure velocimetric index of the umbilical artery.

Treatment:

Device: Ultrasound

Ultrasound - patients with diagnosed hypertensive disorders of pregnancy

Experimental group

Description:

Ultrasound will be used to measure velocimetric index of the umbilical artery.

Treatment:

Device: Ultrasound