PregnancyPIEBNCT01856166
PIEB-PCEA Versus CEI-PCEA for Labor Analgesia in Nulliparous
A study testing Release analgesia by CADD SMITHS PCEA pump, Release analgesia by CADD SMITHS PIEB pump and Levobupivacaine in people with Pregnancy, run by University Hospital, Montpellier at 4 sites in France.
Trial summary
Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates. To assess the best maintainance regimen of epidural analgesia during labor the investigators plan to include 300 nulliparous in this multicenter randomized, double blind trial. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women only
- Conditions the study is for
- Pregnancy
- What is being tested?
- Release analgesia by CADD SMITHS PCEA pump, Release analgesia by CADD SMITHS PIEB pump and Levobupivacaine
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 304 participants
- Where
- 4 sitesFrance
- Study dates
- Jun 2013to Jun 2016
- Phase
- Interventional
- 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 44 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Nulliparous patient with a spontaneous labor at full term, from a normal pregnancy, carrier a singleton in cephalic position, with a distension <4cm and eligible for an epidural analgesia
- Patient has signed informed consent
- Patient affiliated or beneficiary of a social medical insurance
- Patient aged between 18 and 44 years old
Who cannot join
- Morphinic administration before the care
- Anomaly of fetal cardiac rate
- Fetal or maternal anomalies wich don't allow to evaluate motor block
- Known uterine malformation
- Contraindications for thrusts for pregnancy
- Patient protected by law
- Patient under guardianship
Trial locations and contacts
4 sites in 1 country.
France4 sites
Hôpital Mère Enfant
Bron, 69500
CHU d'Estaing
Clermont-Ferrand, 63003
CHU Bicêtre
Le Kremlin-Bicêtre, 94275
CHU of Montpellier
Montpellier, 34000
About this study
Official title: Programmed Intermittent Epidural Bolus Coupled With PCEA (PIEB-PCEA) Versus Continuous Epidural Infusion Coupled With PCEA (CEI-PCEA) for Labor Analgesia in Nulliparous: Effects on Labor Outcomes
Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates.
To assess the best maintainance regimen of epidural analgesia during labor the investigators plan to include 300 nulliparous in this multicenter randomized, double blind trial. The primary outcome will be a composite set of criteria that can lead to instrumented delivery. Secondary outcome will focus on analgesia motor block and satisfaction.
Read the detailed description
Patients will be informed during the anaesthetic consultation and recruited at the beginning of the labor if they comply with inclusion criteria. Habitual proceedings of the placing and induction of epidural analgesia (Local Anaesthetics (AL): Levobupivacaine 0.100% 15mL Sufentanil 10µg). Patients who will not obtain at 30min a pain score < 1/10 will be excluded (epidural analgesia not functional). The upkeep of analgesia will be provided by an automatic pump and randomized in: classic pump and new pump. The mixture used will be the same in the 2 groups: Levobupivacaine 0.0100% + Sufentanil 0.5µg/mL. The classic pump administers AL with a continuous output (8mL/h)even though the new pump administers AL in bolus (8mL every hour; beginning 1h after the induction). The classic pump is a pump CADD SMITHS PCEA (Patient Controlled Epidural Analgesia) with the programming: continuous output 8mL/h; Additional bolus if necessary: 8mL; Maximal dose by hour: 24mL.
The new pump is a pump CADD SMITHS called PIEB (Programmed Intermittent Epidural Bolus) with the programming: intermittent bolus 8mL every hour; Additional bolus if necessary: 8mL; Ban period during 10min between patient bolus and automatic bolus; Maximal dose by hour: 24mL.
In case of the pain reappears and which is not calmed with 2 successive patient bolus, the anaesthetist will be called for the evaluation and administration of a doctor bolus if necessary (Levobupivacaine 0.125% 5mL associated with 50µg of Clonidine).
Collected data will be demographic data, data about the obstetrical labor proceedings, data about pain, motor block, maternal satisfaction, total quantity of administered analgesia, number of patient and doctor bolus wich are asked and administered and neonatal data.
Endpoints will be collected by a doctor in blind of the type of pump (the 2 pumps are the same extern aspect, only the intern programming is different).
In case of caesarean during the labor, patient will be excluded of the study. When a decision of extraction will be taken, patient will receive a bolus of AL according to the anaesthetist decision but not accounted for the dose calculation.
- Conditions
- Pregnancy
- Being tested
- Release analgesia by CADD SMITHS PCEA pump, Release analgesia by CADD SMITHS PIEB pump, Levobupivacaine, Sufentanil
- Keywords
- Nulliparous, Singleton, delivery, pregnancy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Release analgesia by CADD SMITHS PCEA pumpDevice
Analgesia will be release by continuous manner with an automatic pump
Release analgesia by CADD SMITHS PIEB pumpDevice
Analgesia will be release by bolus with an automatic pump
LevobupivacaineDrug
SufentanilDrug
| Study group | Role | What they receive |
|---|---|---|
| CEI-PCEA | Active comparator | Continuous Epidural Infusion coupled with Patient Controlled Epidural Analgesia Receives: Device: Release analgesia by CADD SMITHS PCEA pump; Drug: Levobupivacaine; Drug: Sufentanil |
| PIEB-PCEA | Experimental | Programmed Intermittent Epidural Bolus coupled with Patient Controlled Epidural Analgesia Receives: Device: Release analgesia by CADD SMITHS PIEB pump; Drug: Levobupivacaine; Drug: Sufentanil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurence of a specific clinical criteria which can lead to a complication of the delivery
Specific clinical criteria are:
- Type of posterior engagement
- Type of posterior extrication
- Duration of waiting at complete dilatation > 3 hours
- Duration of expulsive efforts > 40 minutes
- Foetal bradycardia < 100 BPM during 1 minute at least
Measured: Up to 10 hours
Secondary outcomes (5)
Instrumental delivery rate
Measured: up to 10 hours
Pain during the end of labor
Measured: up to 10 hours
Efficacity of epidural analgesia
Measured: up to 10 hours
Efficacity of epidural analgesia
Efficacity of epidural analgesia is defined by a EVN score < 3 at several times of delivery.
Measured: up to 10 hours
Presence of motor block
Presence of motor block is estimated with Bromage and Straigh Raising leg scales.
Measured: Up to 10 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2015
- Study completionJun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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 N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 304 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Estelle MORAU, PhD, Principal investigator, CHU Montpellier - Department of gynaecology and obstetric
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01856166
- Sponsor's protocol ID
- 9147
- Acronym
- PIEB
- Status last verified
- May 2024
- First submitted
- 29 Apr 2013
- Last updated
- 15 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Morau E, Jaillet M, Storme B, Nogue E, Bonnin M, Chassard D, Benhamou D, Nagot N, Dadure C. Does programmed intermittent epidural bolus improve childbirth conditions of nulliparous women compared with patient-controlled epidural analgesia?: A multicentre, randomised, controlled, triple-blind study. Eur J Anaesthesiol. 2019 Oct;36(10):755-762. doi: 10.1097/EJA.0000000000001053.
PubMed 31335447
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Programmed Intermittent Epidural Bolus Coupled With PCEA (PIEB-PCEA) Versus Continuous Epidural Infusion Coupled With PCEA (CEI-PCEA) for Labor Analgesia in Nulliparous: Effects on Labor Outcomes
- ClinicalTrials.gov ID
- NCT01856166
- Acronym / sponsor ID
- PIEB / 9147
- Conditions
- Pregnancy
- Keywords
- Nulliparous, Singleton, delivery, pregnancy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 304 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 17 May 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.
Epidural analgesia still have an impact on obstetric outcomes and especially on instrumented delivery rates.
To assess the best maintainance regimen of epidural analgesia during labor the investigators plan to include 300 nulliparous in this multicenter randomized, double blind trial. The primary outcome will be a composite set of criteria that can lead to instrumented delivery. Secondary outcome will focus on analgesia motor block and satisfaction.
Detailed description
Patients will be informed during the anaesthetic consultation and recruited at the beginning of the labor if they comply with inclusion criteria. Habitual proceedings of the placing and induction of epidural analgesia (Local Anaesthetics (AL): Levobupivacaine 0.100% 15mL Sufentanil 10µg). Patients who will not obtain at 30min a pain score < 1/10 will be excluded (epidural analgesia not functional). The upkeep of analgesia will be provided by an automatic pump and randomized in: classic pump and new pump. The mixture used will be the same in the 2 groups: Levobupivacaine 0.0100% + Sufentanil 0.5µg/mL. The classic pump administers AL with a continuous output (8mL/h)even though the new pump administers AL in bolus (8mL every hour; beginning 1h after the induction). The classic pump is a pump CADD SMITHS PCEA (Patient Controlled Epidural Analgesia) with the programming: continuous output 8mL/h; Additional bolus if necessary: 8mL; Maximal dose by hour: 24mL.
The new pump is a pump CADD SMITHS called PIEB (Programmed Intermittent Epidural Bolus) with the programming: intermittent bolus 8mL every hour; Additional bolus if necessary: 8mL; Ban period during 10min between patient bolus and automatic bolus; Maximal dose by hour: 24mL.
In case of the pain reappears and which is not calmed with 2 successive patient bolus, the anaesthetist will be called for the evaluation and administration of a doctor bolus if necessary (Levobupivacaine 0.125% 5mL associated with 50µg of Clonidine).
Collected data will be demographic data, data about the obstetrical labor proceedings, data about pain, motor block, maternal satisfaction, total quantity of administered analgesia, number of patient and doctor bolus wich are asked and administered and neonatal data.
Endpoints will be collected by a doctor in blind of the type of pump (the 2 pumps are the same extern aspect, only the intern programming is different).
In case of caesarean during the labor, patient will be excluded of the study. When a decision of extraction will be taken, patient will receive a bolus of AL according to the anaesthetist decision but not accounted for the dose calculation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CEI-PCEA | Active comparator | Device: Release analgesia by CADD SMITHS PCEA pump, Drug: Levobupivacaine, Drug: SufentanilContinuous Epidural Infusion coupled with Patient Controlled Epidural Analgesia |
| PIEB-PCEA | Experimental | Device: Release analgesia by CADD SMITHS PIEB pump, Drug: Levobupivacaine, Drug: SufentanilProgrammed Intermittent Epidural Bolus coupled with Patient Controlled Epidural Analgesia |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Nulliparous patient with a spontaneous labor at full term, from a normal pregnancy, carrier a singleton in cephalic position, with a distension <4cm and eligible for an epidural analgesia
- Patient has signed informed consent
- Patient affiliated or beneficiary of a social medical insurance
- Patient aged between 18 and 44 years old
Key exclusion criteria (7 listed)
- Morphinic administration before the care
- Anomaly of fetal cardiac rate
- Fetal or maternal anomalies wich don't allow to evaluate motor block
- Known uterine malformation
- Contraindications for thrusts for pregnancy
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 |
|---|---|---|
| Release analgesia by CADD SMITHS PCEA pumpAnalgesia will be release by continuous manner with an automatic pump | Device | CEI-PCEA |
| Release analgesia by CADD SMITHS PIEB pumpAnalgesia will be release by bolus with an automatic pump | Device | PIEB-PCEA |
| Levobupivacaine | Drug | CEI-PCEA, PIEB-PCEA |
| Sufentanil | Drug | CEI-PCEA, PIEB-PCEA |
Primary outcome
Occurence of a specific clinical criteria which can lead to a complication of the delivery
Time frame: Up to 10 hours
Specific clinical criteria are: * Type of posterior engagement * Type of posterior extrication * Duration of waiting at complete dilatation > 3 hours * Duration of expulsive efforts > 40 minutes * Foetal bradycardia < 100 BPM during 1 minute at least
5 secondary outcomes
Instrumental delivery rate
Time frame: up to 10 hours
Pain during the end of labor
Time frame: up to 10 hours
Efficacity of epidural analgesia
Time frame: up to 10 hours
Efficacity of epidural analgesia
Time frame: up to 10 hours
Presence of motor block
Time frame: Up to 10 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 15 Jun 2026.
- Results publication: PubMed 31335447Morau E, Jaillet M, Storme B, Nogue E, Bonnin M, Chassard D, Benhamou D, Nagot N, Dadure C. Does programmed intermittent epidural bolus improve childbirth conditions of nulliparous women compared with patient-controlled epidural analgesia?: A multicentre, randomised, controlled, triple-blind study. Eur J Anaesthesiol. 2019 Oct;36(10):755-762. doi: 10.1097/EJA.0000000000001053.
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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.
Estelle MORAU, PhD principal investigator
CHU Montpellier - Department of gynaecology and obstetric
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Release analgesia by CADD SMITHS PCEA pump, Release analgesia by CADD SMITHS PIEB pump and Levobupivacaine in people with Pregnancy, run by University Hospital, Montpellier at 4 sites in France.
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 4 inclusion and 7 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 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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.
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?
Occurence of a specific clinical criteria which can lead to a complication of the delivery (time frame: Up to 10 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01856166, which also lists 1 linked publication.
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 15 Jun 2026.