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

Laboring Women Requesting Neuraxial Labor Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02008591
• Other study ID #: 2013P001927
• Status: Completed
• Phase: Phase 4
• First received: November 26, 2013
• Last updated: January 20, 2017
• Start date: November 26, 2013
• Est. completion date: January 27, 2016

Study information

• Verified date: January 2017
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: January 27, 2016
• Est. primary completion date: January 27, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Labor Pain
• Laboring Women Requesting Neuraxial Labor Analgesia

Intervention

Procedure:
• Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique
Three different techniques, using the same medications (bupivacaine and fentanyl)

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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