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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Epidural Technique | Active Comparator | Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min |
|
| Combined Spinal Epidural Technique | Active Comparator | Bupivacaine 2.5 mg with Fentanyl 25 mcg |
|
| Dural Puncture Epidural Technique | Active Comparator | Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique | Procedure | Three different techniques, using the same medications (bupivacaine and fentanyl) |
| Measure | Description | Time Frame |
|---|---|---|
| Maternal Outcomes | Onset, quality, and duration of analgesia, occurrences of hypotension, bradycardia, pruritus, nausea, emesis. | Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal Outcomes | Occurrence of fetal bradycardia or other heart rate changes, changes in fetal heart tracing patterns | Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence C Tsen, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
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Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.
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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.