Labor Pain
Conditions
Keywords
combined spinal epidural (CSE), fetal bradycardia, ultrasound, velocimetric index, hypertension
Brief summary
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.
Interventions
DEVICEUltrasound
Ultrasound scan of the umbilical artery
Sponsors
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 10 minutes | 10 minutes | Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 10 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - pulsatility index (PI) at 10 minutes | 10 minutes | Umbilical artery velocimetric index - pulsatility index (PI) will be measured 10 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - resistance index (RI) at 10 minutes | 10 minutes | Umbilical artery velocimetric index - resistance index (RI) will be measured 10 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Umbilical artery velocimetric index - pulsatility index (PI) at baseline | 5 minutes | Umbilical artery velocimetric index - pulsatility index (PI) will be measured prior to combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - resistance index (RI) at baseline | 5 minutes | Umbilical artery velocimetric index - resistance index (RI) will be measured prior to combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 5 minutes | 5 minutes | Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 5 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - pulsatility index (PI) at 5 minutes | 5 minutes | Umbilical artery velocimetric index - pulsatility index (PI)will be measured 5 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - resistance index (RI) at 5 minutes | 5 minutes | Umbilical artery velocimetric index - resistance index (RI) will be measured 5 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 20 minutes | 20 minutes | Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 20 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - pulsatility index (PI) at 20 minutes | 20 minutes | Umbilical artery velocimetric index - pulsatility index (PI) will be measured 20 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - resistance index (RI) at 20 minutes | 20 minutes | Umbilical artery velocimetric index - resistance index (RI) will be measured 20 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at 30 minutes | 5 minutes | Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured 30 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - pulsatility index (PI) at 30 minutes | 30 minutes | Umbilical artery velocimetric index - pulsatility index (PI) will be measured 30 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Umbilical artery velocimetric index - resistance index (RI) at 30 minutes | 30 minutes | Umbilical artery velocimetric index - resistance index (RI) will be measured 30 minutes after combined spinal epidural, with the uterus in relaxed and contracted states. |
| Pain score at baseline - questionnaire | 1 minute | Pain score - verbal numeric rating scale (0-10) prior to combined spinal epidural |
| Pain score at 10 minutes - questionnaire | 10 minutes | Pain score - verbal numeric rating scale (0-10) at 10 minute after combined spinal epidural |
| Pain score at 30 minutes - questionnaire | 30 minutes | Pain score - verbal numeric rating scale (0-10) at 30 minute3 after combined spinal epidural |
| Sensory block level at 10 minutes | 10 minutes | Sensory block level at 10 minutes following combined spinal epidural |
| presence of fetal persistent late decelerations - questionnaire | 30 minutes | presence of fetal persistent late decelerations will be recorded |
| frequency of uterine contractions | 10 minutes | The number of contractions on the monitor in a 10 minute period. |
| Presence of prolonged hypertonic uterine contractions- questionnaire | 30 minutes | Presence of prolonged hypertonic uterine contractions as measured by the monitor |
| Hypotension: systolic blood pressure less than 80% of baseline | 30 minutes | Systolic blood pressure \< 80% of baseline, monitored q5 for 30 minutes following combined spinal epidural |
| Hypertension: systolic blood pressure greater than 120% of baseline | 30 minutes | Systolic blood pressure \> 120% of baseline, monitored q5 for 30 minutes following combined spinal epidural |
| Bradycardia: heart rate less than 70% of baseline | 30 minutes | Heart rate \< 70% of baseline or a heart rate \< 50bpm, monitored q5 for 30 minutes following combined spinal epidural |
| Desaturation: oxygen level <95% | 30 minutes | Oxygen level \<95%, monitored q5 for 30 minutes following combined spinal epidural |
| fetal heart rate at baseline | 5 minutes | fetal heart rate at baseline, prior to combined spinal epidural |
| fetal heart rate q5 min up to 30 minutes | 30 minutes | fetal heart rate q5 min up to 30 minutes following combined spinal epidural |
| presence of fetal bradycardia - questionnaire | 30 minutes | presence of fetal bradycardia (fetal heart rate \<110) |
| presence of fetal non-reassuring variable deceleration - questionnaire | 30 minutes | presence of fetal non-reassuring variable deceleration will be recorded |
| presence of fetal salutatory variability - questionnaire | 30 minutes | presence of fetal salutatory variability (FHR change\>25beats) will be recorded |
| Neonatal weight | up to 24 hours | Neonatal weight measured after delivery in grams minutes |
| Apgar score at 1 minute | 1 minute | Apgar score at 1 minute |
| Apgar score at 5 minutes | 5 minutes | Apgar score at 5 minutes |
| Mode of delivery - questionnaire | up to 24 hours | Mode of delivery will be recorded as vaginal, assisted (forceps or vacuum), or cesarean |
| Sensory block level at 30 minutes | 30 minutes | Sensory block level at 30 minutes following combined spinal epidural |
| presence of fetal prolonged deceleration - questionnaire | 30 minutes | presence of fetal prolonged deceleration (fetal heart rate \<110/min lasting less than 10 minutes) |
| Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) at baseline | 5 minutes | Umbilical artery velocimetric index - systolic/diastolic ratio (S/D) will be measured prior to combined spinal epidural, with the uterus in relaxed and contracted states. |
Countries
Canada
Contacts
Primary ContactMrinalini Balki, MD
Outcome results
None listed