Impact of Low-Dose Epidural Analgesia on Labour Progression in Low-Risk Women

NCT06987591 | Completed

• 1 other identifier: 6077
• Study Type: observational
• Target: 5,995
• Locations: 1 country
• Sites: 1

Brief Summary

Aim of the study was to analyse data on cervical dilation and fetal descent patterns in low-risk women, who did or did not receive intermittent low-dose epidural analgesia (EA), and who had either a vaginal or a caesarean delivery. Therefore, we conducted a retrospective analysis, retrieving data from October 1st 2008 to October 31st 2018. We selected 6030 women categorized as Robson Group 1, divided into four groups according to the mode of delivery (vaginal or caesarean) and the presence of EA:

• Vaginal delivery with EA (VD-e)
• Vaginal delivery without EA (VD-n)
• Caesarean delivery with EA (CD-e)
• Caesarean delivery without EA (CD-n)

Conditions

Epidural Analgesia, Obstetric

Keywords

Labor epidural analgesia; Cesarean section; Instrumental delivery; Neonatal well-being

Outcome Measures

Primary Outcomes (2)

• Cervical dilation curve

  We modeled the cervical dilation curve using a high-degree mixed polynomial regression. The analysis was conducted separately in women with vaginal or caesarean delivery. The time of complete cervical dilation or caesarean delivery was considered the point 0 for cervical dilation, while the preceding events resulted in negative time compared to the 0.

  First stage of labour (from admission to the delivery suite to full cervical dilation)

• Fetal head descent curve

  We modeled the fetal head descent curve using a mixed polynomial regression. The analysis was conducted separately in women with vaginal or caesarean delivery. The time of station +3 (i.e. vaginal birth) or caesarean delivery was considered the point 0 , while the preceding events resulted in negative time compared to the 0.

  From admission to the delivery room up to the time of delivery (either via vaginal route or caesarean section)

Secondary Outcomes (6)

• Length of active phase

  Up to 24 hours from admission.

• Length of second stage

  Up to 24 hours from admission.

• Type of vaginal delivery

  At delivery

• Maternal complications during vaginal delivery

  At delivery.

• Episiotomy

  At delivery.

Study Arms (4)

VD-e

Women who vaginally delivered and received EA for labour.

VD-n

Women who vaginally delivered and did not receive EA for labour.

CD-e

Women who delivered via intrapartum caesarean section and received EA for labour.

CD-n

Women who delivered via intrapartum caesarean section and did not receive EA for labour.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant patients classified as Robson class 1, who received or not EA for labour and delivered either vaginally or via caesarean route.

You may qualify if:

• Robson class 1 (nulliparous, single, cephalic full-term pregnancy with spontaneous labour)
• maternal age between 18 and 40 years
• neonatal weight between 2500 and 4000 grams
• cervical dilation \<7 cm at admission in the delivery suite

You may not qualify if:

• minimal duration of labour \< 3 hours (from admission to the delivery suite to delivery)

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, 00168, Italy

Location

Related Publications (6)

• Anim-Somuah M, Smyth RM, Cyna AM, Cuthbert A. Epidural versus non-epidural or no analgesia for pain management in labour. Cochrane Database Syst Rev. 2018 May 21;5(5):CD000331. doi: 10.1002/14651858.CD000331.pub4.

  PMID: 29781504 BACKGROUND

• de Vries BS, Mcdonald S, Joseph FA, Morton R, Hyett JA, Phipps H, McGeechan K. Impact of analysis technique on our understanding of the natural history of labour: a simulation study. BJOG. 2021 Oct;128(11):1833-1842. doi: 10.1111/1471-0528.16719. Epub 2021 May 19.

  PMID: 33837643 BACKGROUND

• Vahratian A, Troendle JF, Siega-Riz AM, Zhang J. Methodological challenges in studying labour progression in contemporary practice. Paediatr Perinat Epidemiol. 2006 Jan;20(1):72-8. doi: 10.1111/j.1365-3016.2006.00696.x.

  PMID: 16420344 BACKGROUND

• Friedman EA. Evolution of graphic analysis of labor. Am J Obstet Gynecol. 1978 Dec 1;132(7):824-7. doi: 10.1016/s0002-9378(78)80018-0. No abstract available.

  PMID: 717493 BACKGROUND

• Zhang J, Troendle JF, Yancey MK. Reassessing the labor curve in nulliparous women. Am J Obstet Gynecol. 2002 Oct;187(4):824-8. doi: 10.1067/mob.2002.127142.

  PMID: 12388957 BACKGROUND

• Zhang J, Landy HJ, Ware Branch D, Burkman R, Haberman S, Gregory KD, Hatjis CG, Ramirez MM, Bailit JL, Gonzalez-Quintero VH, Hibbard JU, Hoffman MK, Kominiarek M, Learman LA, Van Veldhuisen P, Troendle J, Reddy UM; Consortium on Safe Labor. Contemporary patterns of spontaneous labor with normal neonatal outcomes. Obstet Gynecol. 2010 Dec;116(6):1281-1287. doi: 10.1097/AOG.0b013e3181fdef6e.

  PMID: 21099592 BACKGROUND

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 15, 2025
• First Posted: May 23, 2025
• Study Start: October 1, 2023
• Primary Completion: December 31, 2024
• Study Completion: May 1, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)