Obstetric PainPhase 4NCT00361712
Effect of Preemptive Epidural Analgesia in Labor on Cytokine Production
A Phase 4 study testing Preemptive epidural analgesia in people with Obstetric Pain, run by Rabin Medical Center at 1 site in Israel.
Trial summary
During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes. Epidural analgesia is commonly performed after the parturient feels labor pain. 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
- Obstetric Pain
- What is being tested?
- Preemptive epidural analgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteIsrael
- Study dates
- Jul 2006to Jul 2006
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age>18
- Singleton pregnancy with no known fetal malformations
- Above or equal to 38 weeks of pregnancy
Who cannot join
- Systemic medical illnesses
- Chronic medications except for iron and vitamins
- Women developing fever > 380C
- Women with history of delivery of children with cerebral palsy
- History of infertility
- Premature contractions
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-inflammatory Cytokine Production in a Mother and a Newborn
During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes.
Epidural analgesia is commonly performed after the parturient feels labor pain.
We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can influence the production of cytokines.
Read the detailed description
The interrelationship between vaginal labor, cytokine production, and epidural analgesia is unknown. Vaginal delivery is thought to induce a maternal inflammatory response. Though epidural analgesia during labor was found to significantly influence peripartum maternal and newborn interleukin concentrations, these studies did not address at what stage epidural analgesia was performed. Preemptive analgesia has been found to be associated with attenuated proinflammatory cytokines, at least in the postoperative period.
Healthy ASA I term parturients (>37 weeks) being accepted into delivery ward and wanting epidural analgesia will be studied.
Parturients will be divided into two groups:
- Group I- those who have painless contractions awaiting augmentation of labor.
- Group II- parturients with cervical dilatation and painful labor (VAS >5).
Parturients in Group I will be given epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). Parturients in Group 2 will be given epidural analgesia as soon as possible.
Epidural analgesia protocol will be identical for both groups: graduated doses of bupivicaine 0.1% 15cc and 100 mcg fentanyl followed by patient controlled analgesia at a concentration of bupivicaine 0.1% and fentanyl 2 mcg/cc delivered at 10cc per hour with possible boluses of 5 cc every ten minutes.
Maternal serum will be drawn before epidural insertion and 18-24 hours after delivery. Placental blood will be drawn after delivery.
These blood sample will be assessed for IL-1Beta, TNF alpha, IL-1ra, IL-2, Il-6, IL-8, IL-10, IL-18.
The patient's chart will be prospectively analyzed for demographic information about parturient and complications and progress of labor.
- Conditions
- Obstetric Pain
- Being tested
- Preemptive epidural analgesia, Standard of care
- Keywords
- Epidural, analgesia, labor, cytokines
- 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.
Preemptive epidural analgesiaProcedure or surgery
Parturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions.
Standard of careDrug
Epidural analgesia with parturients with cervical dilatation and painful labor (VAS >5)
| Study group | Role | What they receive |
|---|---|---|
| Preemptive epidural analgesia | Experimental | Parturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). Receives: Procedure: Preemptive epidural analgesia |
| Standard of care | Active comparator | Parturients with cervical dilatation and painful labor (VAS >5) will receive epidural analgesia as soon as possible Receives: Drug: Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment
Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment
Measured: Right after enrollment
Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery
Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery
Measured: 24 hours after delivery
Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth
Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery
Measured: At birth of parturients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2006 (estimated)
- Study startJul 2006
- Primary completionJul 2006
- Study completionJul 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Obstetric PainStudies of the same condition, open and under way.
- 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
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, sharonorbach, Rabin Medical Center
- Investigators
- Sharon Orbach-Zinger, M.D., Study director, Department of Anesthesiology, Rabin Medical Center/Beilinson Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361712
- Sponsor's protocol ID
- 003692
- Status last verified
- Mar 2018
- First submitted
- 6 Aug 2006
- Last updated
- 9 Apr 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preemptive Epidural Analgesia in Labor on Pro and Anti-inflammatory Cytokine Production in a Mother and a Newborn
- ClinicalTrials.gov ID
- NCT00361712
- Acronym / sponsor ID
- 003692
- Conditions
- Obstetric Pain
- Keywords
- Epidural, analgesia, labor, cytokines
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Jul 2006
- Primary completion
- Jul 2006 (actual)
- Study completion
- Jul 2006 (actual)
- First posted
- 8 Aug 2006 (estimated)
- Results
- Posted 12 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
During labor there is an increased production of inflammatory mediators called cytokines. Higher concentration of certain cytokines has been linked to adverse neonatal and maternal outcomes.
Epidural analgesia is commonly performed after the parturient feels labor pain.
We hypothesis that preemptive epidural analgesia (initiated before labor pain begins)can influence the production of cytokines.
Detailed description
The interrelationship between vaginal labor, cytokine production, and epidural analgesia is unknown. Vaginal delivery is thought to induce a maternal inflammatory response. Though epidural analgesia during labor was found to significantly influence peripartum maternal and newborn interleukin concentrations, these studies did not address at what stage epidural analgesia was performed. Preemptive analgesia has been found to be associated with attenuated proinflammatory cytokines, at least in the postoperative period.
Healthy ASA I term parturients (>37 weeks) being accepted into delivery ward and wanting epidural analgesia will be studied.
Parturients will be divided into two groups:
- Group I- those who have painless contractions awaiting augmentation of labor.
- Group II- parturients with cervical dilatation and painful labor (VAS >5).
Parturients in Group I will be given epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). Parturients in Group 2 will be given epidural analgesia as soon as possible.
Epidural analgesia protocol will be identical for both groups: graduated doses of bupivicaine 0.1% 15cc and 100 mcg fentanyl followed by patient controlled analgesia at a concentration of bupivicaine 0.1% and fentanyl 2 mcg/cc delivered at 10cc per hour with possible boluses of 5 cc every ten minutes.
Maternal serum will be drawn before epidural insertion and 18-24 hours after delivery. Placental blood will be drawn after delivery.
These blood sample will be assessed for IL-1Beta, TNF alpha, IL-1ra, IL-2, Il-6, IL-8, IL-10, IL-18.
The patient's chart will be prospectively analyzed for demographic information about parturient and complications and progress of labor.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preemptive epidural analgesia | Experimental | Procedure: Preemptive epidural analgesiaParturients will receive epidural analgesia immediately upon arrival in the labor ward before onset of painful contractions (VAS<3). |
| Standard of care | Active comparator | Drug: Standard of careParturients with cervical dilatation and painful labor (VAS >5) will receive epidural analgesia as soon as possible |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age>18
- Singleton pregnancy with no known fetal malformations
- Above or equal to 38 weeks of pregnancy
Key exclusion criteria (6 listed)
- Systemic medical illnesses
- Chronic medications except for iron and vitamins
- Women developing fever > 380C
- Women with history of delivery of children with cerebral palsy
- History of infertility
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 |
|---|---|---|
| Preemptive epidural analgesiaParturients will receive early epidural analgesia before onset of painful contractions as oppose to standard of care in which parturients receive epidural analgesia with onset of painful contractions. | Procedure or surgery | Preemptive epidural analgesia |
| Standard of careEpidural analgesia with parturients with cervical dilatation and painful labor (VAS >5) | Drug | Standard of care |
Primary outcome
Maternal Cytokine IL-10 Levels of pg/ml Upon Enrollment
Time frame: Right after enrollment
Maternal serum cytokine IL-10 levels of pg/ml measured upon enrollment
Maternal Cytokine of pg/ml IL-10 Levels 24 Hours After Delivery
Time frame: 24 hours after delivery
Maternal serum cytokine levels of pg/ml IL-10 as measured 24 hours after delivery
Umbilical Cord Cytokine of pg/ml IL-10 Levels at Birth
Time frame: At birth of parturients
Umbilical cord cytokine IL-10 levels pg/ml as measured at delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Sharon Orbach-Zinger, M.D. study director
Department of Anesthesiology, Rabin Medical Center/Beilinson 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 Preemptive epidural analgesia in people with Obstetric Pain, run by Rabin Medical Center at 1 site in Israel.
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 3 inclusion and 6 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 9 Apr 2018. 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 Israel. 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?
Yes. Results are posted in the registry (first posted 12 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Cytokine IL-10 Levels of pg/ml Upon Enrollment (time frame: Right after enrollment). The study lists 3 primary outcomes in all. 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 9 Apr 2018.