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

Brigham and Women's Hospital1 site in 1 country120 target enrollmentNovember 26, 2013

ConditionsLaboring Women Requesting Neuraxial Labor Analgesia

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Laboring Women Requesting Neuraxial Labor Analgesia
Sponsor: Brigham and Women's Hospital
Enrollment: 120
Locations: 1
Primary Endpoint: Maternal Outcomes
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

November 26, 2013

End Date

January 27, 2016

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Brigham and Women's Hospital

Responsible Party

Principal Investigator

Lawrence Ching Tsen

Associate Professor, Harvard Medical School

Brigham and Women's Hospital

Eligibility Criteria

Inclusion Criteria

•Nulliparous (first baby) parturient
•Singleton, vertex gestation at term (37-42 weeks)
•Less than 5 cm dilation
•Desires an epidural technique for labor analgesia

Exclusion Criteria

•Current or historical evidence of clinically significant disease or condition, including diseases of pregnancy (i.e preeclampsia, gestational diabetes)
•Any contraindication to the administration of an epidural technique
•History of hypersensitivity or idiosyncratic reaction to local anesthetic or opioid medications
•Current or historical evidence of a disease which may result in the risk of a cesarean delivery.
•Evidence of anticipated fetal anomalies