Laboring Women Requesting Neuraxial Labor AnalgesiaPhase 4NCT02008591
Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
A Phase 4 study testing Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique in people with Laboring Women Requesting Neuraxial Labor Analgesia, run by Brigham and Women's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Laboring Women Requesting Neuraxial Labor Analgesia
- What is being tested?
- Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Nov 2013to 27 Jan 2016
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
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.
- Being tested
- Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique
- Keywords
- Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Combined Spinal Epidural Technique, Labor Analgesia, Obstetric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural TechniqueProcedure or surgery
Three different techniques, using the same medications (bupivacaine and fentanyl)
| Study group | Role | What they receive |
|---|---|---|
| Epidural Technique | Active comparator | Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min Receives: Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique |
| Combined Spinal Epidural Technique | Active comparator | Bupivacaine 2.5 mg with Fentanyl 25 mcg Receives: Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique |
| Dural Puncture Epidural Technique | Active comparator | Bupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min Receives: Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Outcomes
Onset, quality, and duration of analgesia, occurrences of hypotension, bradycardia, pruritus, nausea, emesis.
Measured: Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours
Secondary outcomes (1)
Fetal Outcomes
Occurrence of fetal bradycardia or other heart rate changes, changes in fetal heart tracing patterns
Measured: Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start26 Nov 2013
- Primary completion27 Jan 2016
- Study completion27 Jan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laboring Women Requesting Neuraxial Labor AnalgesiaStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lawrence Ching Tsen, Brigham and Women's Hospital
- Investigators
- Lawrence C Tsen, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008591
- Sponsor's protocol ID
- 2013P001927
- Status last verified
- Jan 2017
- First submitted
- 26 Nov 2013
- Last updated
- 24 Jan 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Epidural Labor Pain Relief Techniques on Maternal and Fetal Outcomes
- ClinicalTrials.gov ID
- NCT02008591
- Acronym / sponsor ID
- 2013P001927
- Keywords
- Neuraxial Technique, Epidural Technique, Dural Puncture Epidural Technique, Combined Spinal Epidural Technique, Labor Analgesia, Obstetric
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 26 Nov 2013 (actual)
- Primary completion
- 27 Jan 2016 (actual)
- Study completion
- 27 Jan 2016 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized controlled trial with computer generated (Microsoft Excel 2015) assignment placed in sealed envelopes.
| Arm | Type | Receives |
|---|---|---|
| Epidural Technique | Active comparator | Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural TechniqueBupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min |
| Combined Spinal Epidural Technique | Active comparator | Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural TechniqueBupivacaine 2.5 mg with Fentanyl 25 mcg |
| Dural Puncture Epidural Technique | Active comparator | Procedure: Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural TechniqueBupivacaine 0.125% with Fentanyl 2 mcg/mL, 15 mL load over 5 min |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural TechniqueThree different techniques, using the same medications (bupivacaine and fentanyl) | Procedure or surgery | Combined Spinal Epidural Technique, Dural Puncture Epidural Technique, Epidural Technique |
Primary outcome
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.
1 secondary outcome
Fetal Outcomes
Time frame: Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence C Tsen, MD principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Epidural Technique versus Dural Puncture Epidural Technique versus Combined Spinal Epidural Technique in people with Laboring Women Requesting Neuraxial Labor Analgesia, run by Brigham and Women's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maternal Outcomes (time frame: Participants will be followed for the duration of labor analgesia from initiation to delivery, an expected average of 12 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2017.