Impact of Low-Dose Epidural Analgesia on Labour Progression in Robson Class 1 Women: a Retrospective Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 5,995
- Locations
- 1
- Primary Endpoint
- Cervical dilation curve
Study Overview
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)
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 40 Years (Adult)
- Sex
- Female
- Accepts 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)
Outcomes
Primary Outcomes
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.
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
- Type of vaginal delivery(At delivery)
- Episiotomy(At delivery.)
- Maternal complications during vaginal delivery(At delivery.)
- Fetal indicators(After delivery)
- Length of active phase(Up to 24 hours from admission.)
- Length of second stage(Up to 24 hours from admission.)
Investigators
ZANFINI BRUNO ANTONIO
MD
Fondazione Policlinico Universitario Agostino Gemelli IRCCS