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Completed

NCT Number: NCT06987591

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

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)

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Key information

Conditions

Epidural Analgesia, Obstetric

Age range

18 year–40 year

Sex eligibility

Female

Study type

Observational

Primary location

Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. Cervical dilation curve

    Time frame: First 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.

  2. Fetal head descent curve

    Time frame: From 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 outcomes

  1. Length of active phase

    Time frame: Up 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.

  2. Length of second stage

    Time frame: Up to 24 hours from admission.

    Second stage begins at full cervical dilation and ends at delivery.

  3. Type of vaginal delivery

    Time frame: At delivery

    In the VD-e and VD-n groups, description of the type of delivery (eutocic or instrumental)

  4. Maternal complications during vaginal delivery

    Time frame: At delivery.

    Rate of maternal complications (postpartum haemorrhages, perineal lacerations, uterine atony) in the VD groups.

  5. Episiotomy

    Time frame: At delivery.

    Rate of episiotomy in the VD groups.

  6. Fetal indicators

    Time frame: After delivery

    Apgar at 1 and 5 minutes, admission in Neonatal Intensive Care Unit (NICU), death

Sponsors and collaborators

Lead sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
May 23, 2025
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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