Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour

NCT06886555 | Completed DMC

• 1 other identifier: TAIL
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Labour Analgesia, Epidural Anaesthesia; Duration of Labour; Labor, Induced

Keywords

neuraxil analgesia; induced labour

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  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

  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

  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

  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

  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.

Study Arms (1)

women undergoing labour induction

Procedure: Epidural analgesia for labour pain

Interventions

Epidural analgesia for labour pain PROCEDURE

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.

women undergoing labour induction

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: pregnancy
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women with induced labour undergoing epidual analgesia

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fondazione IRCCS Policlinico San Matteo di Pavia: lead

Study Sites (1)

Fondazione IRCCS Policlinico San Matteo, SC AR3 - Anestesia e Terapia Intensiva Postchirurgica

Pavia, Pavia, 27100, Italy

Location

Related Publications (4)

• 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.

  PMID: 32778395 BACKGROUND

• Wong 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.

  PMID: 19384122 BACKGROUND

• Ohel 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.

  PMID: 16522386 BACKGROUND

• Sng 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.

  PMID: 28625301 BACKGROUND

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical doctor- Principal Investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 20, 2025
• Study Start: October 21, 2022
• Primary Completion: December 19, 2024
• Study Completion: December 19, 2024
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

IT (1)