Laboring Women Requesting Neuraxial Labor Analgesia
Conditions
Keywords
Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Combined Spinal Epidural Technique, Labor Analgesia, Obstetric
Brief summary
The primary objective of this study is to compare the onset and duration of the initial dose of medications given through three different epidural (conventional epidural, combined spinal epidural and dural puncture epidural) techniques for labor pain relief. The secondary objective of this study is to compare the fetal effects of these three epidural labor analgesia techniques.
Interventions
PROCEDUREEpidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique
Three different techniques, using the same medications (bupivacaine and fentanyl)
Sponsors
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Anesthesiologist performing technique and bedside nurse instructed not to reveal randomization arm to the patient or study co-investigator who was waiting outside the room, and notified only after completion of the neuraxial placement protocol.
Intervention model description
Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
* 1\. Nulliparous (first baby) parturient 2. Singleton, vertex gestation at term (37-42 weeks) 3. Less than 5 cm dilation 4. Desires an epidural technique for labor analgesia
Exclusion criteria
\- 1. Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes) 2. Any contraindication to the administration of an epidural technique 3. History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications 4. Current or historical evidence of a disease which may result in the risk of a cesarean delivery. 5\. Evidence of anticipated fetal anomalies
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maternal Outcomes | Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours | Onset, quality, and duration of analgesia, occurrences of hypotension, bradycardia, pruritus, nausea, emesis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fetal Outcomes | Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours | Occurrence of fetal bradycardia or other heart rate changes, changes in fetal heart tracing patterns |
Countries
United States
Outcome results
None listed