Labor PainPhase 4NCT04888858
Effect of Epidural Analgesia During Labor on Force of Maternal Push
A Phase 4 study testing Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution) in people with Labor Pain and Analgesia, run by Henry Ford Health System at 1 site in United States.
Trial summary
There are multiple factors that determine progress of normal vaginal delivery. Frequency, duration and strength of uterine contractions are important for progress throughout labor, and abdominal wall muscle contractions contribute to progress during the final stage. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Labor Pain, Analgesia, Maternal; Procedure
- What is being tested?
- Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Nov 2020to 2 Jul 2022
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult (18 years and older)
- Pregnant women in their third trimester
- Able to read and speak English
- Capacity to consent to participate
- Receiving a labor epidural catheter during their labor and delivery at HFH-Main
Who cannot join
- Severe cardiac disease
- People who are unable/medically recommended not to perform valsalva maneuvers
- People who are not undergoing labor epidural analgesia
Trial locations and contacts
1 site in 1 country.
About this study
There are multiple factors that determine progress of normal vaginal delivery. Frequency, duration and strength of uterine contractions are important for progress throughout labor, and abdominal wall muscle contractions contribute to progress during the final stage. Epidural analgesia helps to alleviate the pain associated with uterine contractions, this however this comes at the expense of prolonging labor by reducing the strength of abdominal wall muscle contractions.
The purpose of this prospective study is to quantify how much epidurals decrease the strength of abdominal wall contractions. Intraabdominal pressure will be used as surrogate to strength of abdominal wall contractions, and it will be measured via a foley catheter inserted into the urinary bladder as part of standard procedure for patients receiving labor epidurals. We will compare the change in intraabdominal pressure when patients perform forceful abdominal contractions (valsalva maneuvers) prior to and during epidural analgesia. This will lay the foundation for a future study in which we plan to compare the effects of different epidural analgesia types and concentrations on abdominal wall muscle contractions.
- Conditions
- Labor Pain, Analgesia, Maternal; Procedure
- Being tested
- Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)
- Medical subject headings
- Labor Pain, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)Drug
As part of standard protocol for all patients who receive a labor epidural, the epidural will then be tested using 3ml of 1.5% lidocaine and 1:200,000 epinephrine test solution, and the epidural catheter will then be loaded with 10ml of 0.125% bupivacaine solution. The epidural catheter will then be connected to a programmed intermittent epidural bolus pump which will administer 5ml of a 0.125% bupivacaine/2mcg fentanyl solution every 30minutes. The first dose will be given following 30minutes after the loading dose. 30 minutes after loading the loading dose and after the first pump dose has been given, we will assess the VAS pain scores and the level of the analgesic based on decreased sensation to ice.
| Study group | Role | What they receive |
|---|---|---|
| Epidural Analgesia | Experimental | All subjects will be given epidural analgesia to treat their labor pain. As part of standard protocol for all patients who receive a labor epidural, the epidural will then be tested using 3ml of 1.5% lidocaine and 1:200,000 epinephrine test solution, and the epidural catheter will then be loaded with 10ml of 0.125% bupivacaine solution. The epidural catheter will then be connected to a programmed intermittent epidural bolus pump which will administer 5ml of a 0.125% bupivacaine/2mcg fentanyl solution every 30minutes. The first dose will be given following 30minutes after the loading dose. 30 minutes after loading the loading dose and after the first pump dose has been given, we will assess the VAS pain scores and the level of the analgesic based on decreased sensation to ice. Receives: Drug: Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in intraabdominal pressure (surrogate of maternal force)
The change in intraabdominal pressure will be measured prior to receiving epidural analgesia, and again at 1 and 2 hours following administration. The change observed before and after will be compared to quantify the decreased change following epidural administration.
Measured: 2 hours following initial administration of labor epidural
Secondary outcomes (3)
Mode of delivery
Whether the child is delivered via vaginal or cesarean birth.
Measured: Up to 72 hours after initial administration of labor epidural
Duration of second stage of labor
How long the second stage of labor takes.
Measured: Up to 72 hours after initial administration of labor epidural
Apgar scores
The apgar scores will be measured.
Measured: Up to 72 hours after initial administration of labor epidural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2021
- Study start2 Nov 2020
- Primary completion2 Jul 2022
- Study completion2 Jul 2022
Why it stopped: The PI, Dr. Younger, left Henry Ford Health.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The force of the maternal push when performing Valsalva maneuver will be compared before and after administration of epidural analgesia.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Nowak, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04888858
- Sponsor's protocol ID
- 14173
- Status last verified
- Sep 2023
- First submitted
- 6 May 2021
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to share individual participant data with other researchers.
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Epidural Analgesia During Labor on Force of Maternal Push
- ClinicalTrials.gov ID
- NCT04888858
- Acronym / sponsor ID
- 14173
- Conditions
- Labor Pain, Analgesia, Maternal; Procedure
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The PI, Dr. Younger, left Henry Ford Health.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- 2 Nov 2020 (actual)
- Primary completion
- 2 Jul 2022 (actual)
- Study completion
- 2 Jul 2022 (actual)
- First posted
- 17 May 2021 (actual)
- 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.
There are multiple factors that determine progress of normal vaginal delivery. Frequency, duration and strength of uterine contractions are important for progress throughout labor, and abdominal wall muscle contractions contribute to progress during the final stage. Epidural analgesia helps to alleviate the pain associated with uterine contractions, this however this comes at the expense of prolonging labor by reducing the strength of abdominal wall muscle contractions.
The purpose of this prospective study is to quantify how much epidurals decrease the strength of abdominal wall contractions. Intraabdominal pressure will be used as surrogate to strength of abdominal wall contractions, and it will be measured via a foley catheter inserted into the urinary bladder as part of standard procedure for patients receiving labor epidurals. We will compare the change in intraabdominal pressure when patients perform forceful abdominal contractions (valsalva maneuvers) prior to and during epidural analgesia. This will lay the foundation for a future study in which we plan to compare the effects of different epidural analgesia types and concentrations on abdominal wall muscle contractions.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The force of the maternal push when performing Valsalva maneuver will be compared before and after administration of epidural analgesia.
| Arm | Type | Receives |
|---|---|---|
| Epidural Analgesia | Experimental | Drug: Epidural analgesia (0.125% bupivacaine/2mcg fentanyl solution)All subjects will be given epidural analgesia to treat their labor pain. As part of standard protocol for all patients who receive a labor epidural, the epidural will then be tested using 3ml of 1.5% lidocaine and 1:200,000 epinephrine test solution, and the epidural catheter will then be loaded with 10ml of 0.125% bupivacaine solution. The epidural catheter will then be connected to a programmed intermittent epidural bolus pump which will administer 5ml of a 0.125% bupivacaine/2mcg fentanyl solution every 30minutes. The first dose will be given following 30minutes after the loading dose. 30 minutes after loading the loading dose and after the first pump dose has been given, we will assess the VAS pain scores and the level of the analgesic based on decreased sensation to ice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18 years and older)
- Pregnant women in their third trimester
- Able to read and speak English
- Capacity to consent to participate
- Receiving a labor epidural catheter during their labor and delivery at HFH-Main
Key exclusion criteria (3 listed)
- Severe cardiac disease
- People who are unable/medically recommended not to perform valsalva maneuvers
- People who are not undergoing labor epidural analgesia
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 analgesia (0.125% bupivacaine/2mcg fentanyl solution)As part of standard protocol for all patients who receive a labor epidural, the epidural will then be tested using 3ml of 1.5% lidocaine and 1:200,000 epinephrine test solution, and the epidural catheter will then be loaded with 10ml of 0.125% bupivacaine solution. The epidural catheter will then be connected to a programmed intermittent epidural bolus pump which will administer 5ml of a 0.125% bupivacaine/2mcg fentanyl solution every 30minutes. The first dose will be given following 30minutes after the loading dose. 30 minutes after loading the loading dose and after the first pump dose has been given, we will assess the VAS pain scores and the level of the analgesic based on decreased sensation to ice. | Drug | Epidural Analgesia |
Primary outcome
The change in intraabdominal pressure (surrogate of maternal force)
Time frame: 2 hours following initial administration of labor epidural
The change in intraabdominal pressure will be measured prior to receiving epidural analgesia, and again at 1 and 2 hours following administration. The change observed before and after will be compared to quantify the decreased change following epidural administration.
3 secondary outcomes
Mode of delivery
Time frame: Up to 72 hours after initial administration of labor epidural
Duration of second stage of labor
Time frame: Up to 72 hours after initial administration of labor epidural
Apgar scores
Time frame: Up to 72 hours after initial administration of labor epidural
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
- Individual participant dataSharing planned: No. There is not a plan to share individual participant data with other researchers.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 analgesia (0.125% bupivacaine/2mcg fentanyl solution) in people with Labor Pain and Analgesia, run by Henry Ford Health System 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 5 inclusion and 3 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: withdrawn, as of the sponsor's last update on 25 Sep 2023. 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 was withdrawn before enrolling participants, so there are no results.
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?
The change in intraabdominal pressure (surrogate of maternal force) (time frame: 2 hours following initial administration of labor epidural). 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 25 Sep 2023.