Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes

• Sponsor: Brigham and Women's Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02008591
• Collaborator: (none)
• Enrollment: 120
• Location: 1
• Arms: 3
• Actual Duration (Months): 26
• Patients Per Site Per Month: 4.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Laboring Women Requesting Neuraxial Labor Analgesia	Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 120 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.
• Masking: Triple (Participant, 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.
• Primary Purpose: Treatment
• Official Title: Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
• Actual Study Start Date: Nov 26, 2013
• Actual Primary Completion Date: Jan 27, 2016
• Actual Study Completion Date: Jan 27, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Epidural Technique Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min	Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique; Three different techniques, using the same medications (bupivacaine and fentanyl)
Active Comparator: Combined Spinal Epidural Technique Bupivacaine 2.5 mg with Fentanyl 25 mcg	Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique; Three different techniques, using the same medications (bupivacaine and fentanyl)
Active Comparator: Dural Puncture Epidural Technique Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min	Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique; Three different techniques, using the same medications (bupivacaine and fentanyl)

Outcome Measures

Primary Outcome Measures

1. 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 Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 50 Years
• Sexes Eligible for Study: Female
• Accepts 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.

1. Evidence of anticipated fetal anomalies

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

• Brigham and Women's Hospital

Investigators

• Principal Investigator: Lawrence C Tsen, MD, Brigham and Women's Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lawrence Ching Tsen, Associate Professor, Harvard Medical School, Brigham and Women's Hospital
• ClinicalTrials.gov Identifier: NCT02008591
• Other Study ID Numbers: 2013P001927
• First Posted: Dec 11, 2013
• Last Update Posted: Jan 24, 2017
• Last Verified: Jan 1, 2017

• Keywords provided by Lawrence Ching Tsen, Associate Professor, Harvard Medical School, Brigham and Women's Hospital: Neuraxial Technique; Epidural Technique; Dural Puncture Epidural Technique; Combined Spinal Epidural Technique; Labor Analgesia; Obstetric
• Additional relevant MeSH terms: Labor Pain

Study Results

No Results Posted as of Jan 24, 2017