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

Impact of Low-Dose Epidural Analgesia on Labour Progression in Robson Class 1 Women: a Retrospective Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06987591
Enrollment
5995
Registered
2025-05-23
Start date
2023-10-01
Completion date
2025-05-01
Last updated
2025-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epidural Analgesia, Obstetric

Keywords

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

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)

Interventions

None listed

Sponsors

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Cervical dilation curveFirst stage of labour (from admission to the delivery suite to full cervical dilation)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.
Fetal head descent curveFrom admission to the delivery room up to the time of delivery (either via vaginal route or caesarean section)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.

Secondary

MeasureTime frameDescription
Type of vaginal deliveryAt deliveryIn the VD-e and VD-n groups, description of the type of delivery (eutocic or instrumental)
Maternal complications during vaginal deliveryAt delivery.Rate of maternal complications (postpartum haemorrhages, perineal lacerations, uterine atony) in the VD groups.
Length of active phaseUp to 24 hours from admission.The beginning of the active phase was defined in the presence of regular painful uterine contractions, a substantial degree of cervical effacement and more rapid cervical dilation. Active phase ends at full cervical dilation.
Fetal indicatorsAfter deliveryApgar at 1 and 5 minutes, admission in Neonatal Intensive Care Unit (NICU), death
EpisiotomyAt delivery.Rate of episiotomy in the VD groups.
Length of second stageUp to 24 hours from admission.Second stage begins at full cervical dilation and ends at delivery.

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 29, 2026