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Completed

NCT Number: NCT02008591

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

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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Key information

Conditions

Laboring Women Requesting Neuraxial Labor Analgesia

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.
  • Evidence of anticipated fetal anomalies

Treatment and study plan

Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique

Procedure

Three different techniques, using the same medications (bupivacaine and fentanyl)

Primary outcomes

  1. Maternal Outcomes

    Time frame: 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 outcomes

  1. Fetal Outcomes

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Dec 11, 2013
Registry last updated
Jan 24, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.