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NCT01621230 · ClinicalTrials.gov registry record · Phase 4
Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor
A Phase 4 study, sponsored by University of Texas Southwestern Medical Center.
- Completed
- Registry status
- Phase 4
- Development phase
- 481
- Enrollment target
NCT01621230 is a Phase 4 study that has completed, run by University of Texas Southwestern Medical Center. The registered enrollment target is 481 participants.
The verdict
NCT01621230, a Phase 4 study, has completed, sponsored by University of Texas Southwestern Medical Center.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 481 participants
- Enrollment target
Study Summary
The aim of this study is to measure the effects of bupivacaine administered via epidural catheters on indices of motor blockade ascertained during the second stage of labor. This is a randomized, double-blind, controlled trial designed to address the primary research question: Does bupivacaine lengthen the second stage of labor? The secondary research question is: Is there other evidence of motor blockade attributable to bupivacaine during the second stage of labor? The investigators know from prior studies that the length of the second stage in nulliparous women delivered at Parkland Hospital without epidural analgesia is 28 minutes. The investigators hypothesize in this now proposed study that epidural analgesia with bupivacaine will significantly increase this baseline from 28 minutes to 37 minutes or more (a 33% increase) thus implicating motor blockade. Baseline data for the Bromage and Breen scores during the second stage as well as the uterine contractility data are not available as these indices of motor blockade have not here-to-fore been studied in this context. Currently at Parkland Hospital, 82% of nulliparous women undergoing induction of labor at term receive continuous epidural infusions with bupivacaine during the first and second stages of labor. Such women will be identified when admitted for scheduled inductions at Parkland. After informed consent is obtained standard management of labor induction will be provided. Those consented women reaching 8 cm cervical dilation will be randomized. Group I will receive bupivacaine plus fentanyl via epidural catheter during the second stage (i.e. 10 cm dilation) and Group II will receive only fentanyl infusion via epidural catheter (see study procedure below). Both the patient and the caregiver will be blinded as to whether the patient is in the bupivacaine plus fentanyl arm or the fentanyl only arm. To detect a 33% increase (from 28 minutes to 37 minutes) in the primary outcome the investigators need a tot
Interventions
- DRUG Epidural Bupivacaine plus fentanyl
- DRUG Epidural fentanyl
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 481 participants |
| Start Date | 2009-09 |
| Est. Completion | 2013-07 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01621230
The ClinicalTrials.gov registry entry for NCT01621230 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 481 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Texas Southwestern Medical Center, which has 837 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Epidural Bupivacaine plus fentanyl is the first listed.
NCT01621230 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01621230 about?
NCT01621230 is a clinical study titled "Effects of Bupivacaine Induced Motor Blockade During the Second Stage of Labor". The aim of this study is to measure the effects of bupivacaine administered via epidural catheters on indices of motor blockade ascertained during the second stage of labor. This is a randomized, double-blind, controlled trial designed to address the primary research question: Does bupivacaine lengt...
What is the current status of trial NCT01621230?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 481 participants. The study started on 2009-09. Estimated completion is 2013-07.
What interventions are being tested in trial NCT01621230?
The interventions under investigation include: Epidural Bupivacaine plus fentanyl (DRUG), Epidural fentanyl (DRUG).
Who is sponsoring clinical trial NCT01621230?
This trial is sponsored by University of Texas Southwestern Medical Center, which has 837 total clinical trials registered on ClinicalTrials.gov.
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