Clinical trial NCT06987591: Impact of Low-Dose Epidural Analgesia on Labour Progression in Low-Risk Women
Official title: Impact of Low-Dose Epidural Analgesia on Labour Progression in Robson Class 1 Women: a Retrospective Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Epidural Analgesia, Obstetric
Keywords: Labor epidural analgesia
Cesarean section
Instrumental delivery
Neonatal well-being
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 5995
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
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.

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)


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

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

Primary outcomes:
measure: Cervical dilation curve
timeFrame: First stage of labour (from admission to the delivery suite to full cervical dilation)
measure: Fetal head descent curve
timeFrame: From admission to the delivery room up to the time of delivery (either via vaginal route or caesarean section)
Secondary outcomes:
measure: Length of active phase
timeFrame: Up to 24 hours from admission.
measure: Length of second stage
timeFrame: Up to 24 hours from admission.
measure: Type of vaginal delivery
timeFrame: At delivery
measure: Maternal complications during vaginal delivery
timeFrame: At delivery.
measure: Episiotomy
timeFrame: At delivery.
measure: Fetal indicators
timeFrame: After delivery
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario A. Gemelli IRCCS
state: RM
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.