Labour Analgesia, Epidural AnaesthesiaTAILNCT06886555
Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour
An observational study of Labour Analgesia, Epidural Anaesthesia and Duration of Labour, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
Trial summary
The aim of this observational study is to assess the effect of early labour analgesia on obstetric and neonatal outcomes in induced labour in primiparous women with a full-term pregnancy whose labour was induced with a Cook balloon or prostaglandins. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Labour Analgesia, Epidural Anaesthesia, Duration of Labour, Labor, Induced
- What is being tested?
- Epidural analgesia for labour pain
- Type of treatment
- Surgery or procedure
- How many people
- 400 participants
- Where
- 1 siteItaly
- Study dates
- 21 Oct 2022to 19 Dec 2024
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: women with induced labour undergoing epidual analgesia
Who may be able to join
- Age > 18 years;
- Primipara;
- Single pregnancy;
- Gestational age > 36 weeks;
- Induced labour with Bishop Score < 6;
- Cervical dilatation at start of analgesia ≤ 6 cm;
- ASA Class 2.
Who cannot join
- Endouterine fetal death;
- Anhydramnios:
- Trial labour after caesarean section;
- Cardiotocogram class ≥2 before start of analgesia;
- Third trimester bleeding;
- Patient refusal;
- Inability to understand informed consent.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione IRCCS Policlinico San Matteo, SC AR3 - Anestesia e Terapia Intensiva Postchirurgica
Pavia, Pavia, 27100
About this study
The aim of this observational study is to assess the effect of early labour analgesia on obstetric and neonatal outcomes in induced labour in primiparous women with a full-term pregnancy whose labour was induced with a Cook balloon or prostaglandins.
It aims to answer whether early labour analgesia (< 4 centimetres of cervical dilation) prolongs the duration of labour. Secondary outcomes will be Incidence of caesarean section, use of oxytocin, onset of fetal heart rate abnormalities within 30 minutes of augmentation, incidence of episiotomy, amount of blood loss, need for epidural catheter repositioning due to inadequate analgesia, onset of breakthrough pain defined as need for "rescue" top-ups within 60 minutes of previous top-ups, Apgar score (at 1 and 5 minutes), neonatal umbilical pH and neonatal intensive care unit admission. Patients who received early partoanalgesia were compared for the proposed outcomes with patients who received partoanalgesia in active labour (cervical dilation > 4 centimetres).
- Being tested
- Epidural analgesia for labour pain
- Keywords
- neuraxil analgesia, induced labour
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural analgesia for labour painProcedure or surgery
Patients were divided into two groups according to repertorised cervical dilatation at the start of analgesia: Group A < 4 centimetres (latent stage according to National Institute for Health and Care Excellence guidelines) and Group B between 4 and 6 centimetres.
| Study group | Role | What they receive |
|---|---|---|
| women undergoing labour induction | Not described Receives: Procedure: Epidural analgesia for labour pain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of labour
The primary objective is to compare the duration of the first stage of labour (measured in minutes) between women who received early neuraxial analgesia in the latent phase of the first stage and those who received it in the active stage. First stage duration is the time elapsed from the onset of labour, as diagnosed by an experienced obstetrician, until 10 centimetres of cervical dilation is reached.
The co-primary objective is to compare the duration of the second stage (measured in minutes) between the two populations.
Second stage duration is the time from 10 centimetres of cervical dilation to birth.
Data on these outcomes are recorded by the obstetric team in the patient's chart during labour.
Measured: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Secondary outcomes (11)
Incidence of operative deliveries
The incidence of operative deliveries by obstetrical suction cup for lack of progression of the presented part or presence of fetal heartbeat abnormalities was assessed. Data relating to the mode of delivery and events are recorded in the patient's medical chart by the obstetric team during labour.
Measured: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Incidence of Episiotomy
The incidence of episitomy due to lack of progression of the presented part or presence of fetal heartbeat abnormalities was assessed. Data on this outcome is recorded in the patient's medical chart by the obstetric team during labour.
Measured: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Incidence of caesarean section during labour
The incidence of caesarean section in labour was assessed. The causes of caesarean section considered were: first stage prolongation, second stage prolongation, fetal heartbeat abnormalities.Data on this outcome is recorded by the obstetric team in the patient's chart during labour.
Measured: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Incidence of Obstetric lacerations
The incidence of grade I, II, III obstetric lacerations was evaluated. Data on this outcome is recorded by the obstetric team in the patient's chart during labour.
Measured: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Oxytocin consumption
The amount of oxytocin used during labour was assessed. Data on this outcome is recorded by the obstetric team in the patient's chart during labour.
The amount was measured in units per minute.
Measured: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Peridural catheter repositioning
The incidence of epidural catheter repositioning for inadequate analgesia was measured.
Analgesia was defined as inadequate if the Visual Analogue Scale > 4 30 minutes after analgesia was administered.
During labour analgesia, this event was recorded by the anaesthetist on duty in the anaesthesia chart.
Measured: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Fetal heart rate abnormalities
Fetal heart rate abnormalities occurring within 30 minutes of local anaesthetic or neuroaxial opioid administration have been recorded. The American Congress of Obstetricians and Gynecologists classification was used for the identification of trace abnormalities. Abnormal foetal heart rate are recorded as they occur by the obstetrician in patient's medical chart.
Measured: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Apgar score
The Apgar score is assessed by a paediatrician using a scale from 0 to 10 at 1 minute and 5 minutes after birth. The information is then recorded in the baby's and mother's medical records.
Measured: Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
pH Neonatal umbilical cord
The arterial pH of the umbilical cord is assessed.After delivery the obstetrician takes a sample of umbilical arterial blood to measure pH. The information is then recorded on baby's and mother's medical chart.
Measured: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Admission to neonatal intensive care unit
This outcome is assessed from the moment of birth until 2 hours after delivery. The event is recorded in the mother's medical record.
Measured: Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Administering a 'rescue' epidural analgesia
The need for a 'rescue' epidural was assessed. The time of administration of each epidural top up was recorded both on patient medical chart and on anaesthesia medical chart. When, after initial benefit, the patient experienced a recurrence of pain (Visual analogue Score greater than four) and needed an additional top up within 60 minutes from previous epidural bolus, the event was registered.
Measured: Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start21 Oct 2022
- Primary completion19 Dec 2024
- Study completion19 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Labour Analgesia, Epidural AnaesthesiaStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Policlinico San Matteo di PaviaThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Silvia Poma, Fondazione IRCCS Policlinico San Matteo di Pavia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06886555
- Sponsor's protocol ID
- TAIL
- Acronym
- TAIL
- Status last verified
- Mar 2025
- First submitted
- 25 Feb 2025
- Last updated
- 20 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Simpson KR. Cervical Ripening and Labor Induction and Augmentation, 5th Edition. Nurs Womens Health. 2020 Aug;24(4):S1-S41. doi: 10.1016/j.nwh.2020.04.005.
PubMed 32778395Wong CA, McCarthy RJ, Sullivan JT, Scavone BM, Gerber SE, Yaghmour EA. Early compared with late neuraxial analgesia in nulliparous labor induction: a randomized controlled trial. Obstet Gynecol. 2009 May;113(5):1066-1074. doi: 10.1097/AOG.0b013e3181a1a9a8.
PubMed 19384122Ohel G, Gonen R, Vaida S, Barak S, Gaitini L. Early versus late initiation of epidural analgesia in labor: does it increase the risk of cesarean section? A randomized trial. Am J Obstet Gynecol. 2006 Mar;194(3):600-5. doi: 10.1016/j.ajog.2005.10.821.
PubMed 16522386Sng BL, Sia ATH. Maintenance of epidural labour analgesia: The old, the new and the future. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):15-22. doi: 10.1016/j.bpa.2017.01.002. Epub 2017 Jan 12.
PubMed 28625301
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour
- ClinicalTrials.gov ID
- NCT06886555
- Acronym / sponsor ID
- TAIL / TAIL
- Keywords
- neuraxil analgesia, induced labour
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Fondazione IRCCS Policlinico San Matteo di PaviaUniversity, hospital or other
- Study start
- 21 Oct 2022 (actual)
- Primary completion
- 19 Dec 2024 (actual)
- Study completion
- 19 Dec 2024 (actual)
- First posted
- 20 Mar 2025 (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.
The aim of this observational study is to assess the effect of early labour analgesia on obstetric and neonatal outcomes in induced labour in primiparous women with a full-term pregnancy whose labour was induced with a Cook balloon or prostaglandins.
It aims to answer whether early labour analgesia (< 4 centimetres of cervical dilation) prolongs the duration of labour. Secondary outcomes will be Incidence of caesarean section, use of oxytocin, onset of fetal heart rate abnormalities within 30 minutes of augmentation, incidence of episiotomy, amount of blood loss, need for epidural catheter repositioning due to inadequate analgesia, onset of breakthrough pain defined as need for "rescue" top-ups within 60 minutes of previous top-ups, Apgar score (at 1 and 5 minutes), neonatal umbilical pH and neonatal intensive care unit admission. Patients who received early partoanalgesia were compared for the proposed outcomes with patients who received partoanalgesia in active labour (cervical dilation > 4 centimetres).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| women undergoing labour induction | – | Procedure: Epidural analgesia for labour pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women with induced labour undergoing epidual analgesia
Key inclusion criteria (7 listed)
- Age > 18 years;
- Primipara;
- Single pregnancy;
- Gestational age > 36 weeks;
- Induced labour with Bishop Score < 6;
Key exclusion criteria (7 listed)
- Endouterine fetal death;
- Anhydramnios:
- Trial labour after caesarean section;
- Cardiotocogram class ≥2 before start of analgesia;
- Third trimester bleeding;
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 for labour painPatients were divided into two groups according to repertorised cervical dilatation at the start of analgesia: Group A < 4 centimetres (latent stage according to National Institute for Health and Care Excellence guidelines) and Group B between 4 and 6 centimetres. | Procedure or surgery | women undergoing labour induction |
Primary outcome
Duration of labour
Time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
The primary objective is to compare the duration of the first stage of labour (measured in minutes) between women who received early neuraxial analgesia in the latent phase of the first stage and those who received it in the active stage. First stage duration is the time elapsed from the onset of labour, as diagnosed by an experienced obstetrician, until 10 centimetres of cervical dilation is reached. The co-primary objective is to compare the duration of the second stage (measured in minutes) between the two populations. Second stage duration is the time from 10 centimetres of cervical dilation to birth. Data on these outcomes are recorded by the obstetric team in the patient's chart during labour.
11 secondary outcomes
Incidence of operative deliveries
Time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Incidence of Episiotomy
Time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Incidence of caesarean section during labour
Time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Incidence of Obstetric lacerations
Time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Oxytocin consumption
Time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Peridural catheter repositioning
Time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Fetal heart rate abnormalities
Time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Apgar score
Time frame: Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
pH Neonatal umbilical cord
Time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Admission to neonatal intensive care unit
Time frame: Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Administering a 'rescue' epidural analgesia
Time frame: Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
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 20 Mar 2025.
- Results publication: PubMed 32778395Simpson KR. Cervical Ripening and Labor Induction and Augmentation, 5th Edition. Nurs Womens Health. 2020 Aug;24(4):S1-S41. doi: 10.1016/j.nwh.2020.04.005.
- Results publication: PubMed 19384122Wong CA, McCarthy RJ, Sullivan JT, Scavone BM, Gerber SE, Yaghmour EA. Early compared with late neuraxial analgesia in nulliparous labor induction: a randomized controlled trial. Obstet Gynecol. 2009 May;113(5):1066-1074. doi: 10.1097/AOG.0b013e3181a1a9a8.
- Results publication: PubMed 16522386Ohel G, Gonen R, Vaida S, Barak S, Gaitini L. Early versus late initiation of epidural analgesia in labor: does it increase the risk of cesarean section? A randomized trial. Am J Obstet Gynecol. 2006 Mar;194(3):600-5. doi: 10.1016/j.ajog.2005.10.821.
- Results publication: PubMed 28625301Sng BL, Sia ATH. Maintenance of epidural labour analgesia: The old, the new and the future. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):15-22. doi: 10.1016/j.bpa.2017.01.002. Epub 2017 Jan 12.
- Individual participant dataSharing planned: Undecided
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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?
An observational study of Labour Analgesia, Epidural Anaesthesia and Duration of Labour, run by Fondazione IRCCS Policlinico San Matteo di Pavia at 1 site in Italy.
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 7 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 20 Mar 2025. 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 Italy. 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?
Duration of labour (time frame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.). 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 NCT06886555, which also lists 4 linked publications.
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 20 Mar 2025.