Epidural Analgesia, ObstetricNCT06987591
Impact of Low-Dose Epidural Analgesia on Labour Progression in Low-Risk Women
An observational study of Epidural Analgesia, Obstetric, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Epidural Analgesia, Obstetric
- How many people
- 5,995 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2023to 1 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant patients classified as Robson class 1, who received or not EA for labour and delivered either vaginally or via caesarean route.
Who may be able to join
- 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
Who cannot join
- minimal duration of labour < 3 hours (from admission to the delivery suite to delivery)
Trial locations and contacts
1 site in 1 country.
Italy1 site
Fondazione Policlinico Universitario A. Gemelli IRCCS
Rome, RM, 00168
About this study
Official title: Impact of Low-Dose Epidural Analgesia on Labour Progression in Robson Class 1 Women: a Retrospective Study
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Up to 24 hours from admission.
Length of second stage
Second stage begins at full cervical dilation and ends at delivery.
Measured: Up to 24 hours from admission.
Type of vaginal delivery
In the VD-e and VD-n groups, description of the type of delivery (eutocic or instrumental)
Measured: At delivery
Maternal complications during vaginal delivery
Rate of maternal complications (postpartum haemorrhages, perineal lacerations, uterine atony) in the VD groups.
Measured: At delivery.
Episiotomy
Rate of episiotomy in the VD groups.
Measured: At delivery.
Fetal indicators
Apgar at 1 and 5 minutes, admission in Neonatal Intensive Care Unit (NICU), death
Measured: After delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start1 Oct 2023
- Primary completion31 Dec 2024
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Epidural Analgesia, ObstetricStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 5,995 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZANFINI BRUNO ANTONIO, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987591
- Sponsor's protocol ID
- 6077
- Status last verified
- May 2025
- First submitted
- 15 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For patient's privacy protection.
Publications
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.
PubMed 29781504de 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.
PubMed 33837643Vahratian 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.
PubMed 16420344Friedman 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.
PubMed 717493Zhang 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.
PubMed 12388957Zhang 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.
PubMed 21099592
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Low-Dose Epidural Analgesia on Labour Progression in Robson Class 1 Women: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06987591
- Acronym / sponsor ID
- 6077
- Conditions
- Epidural Analgesia, Obstetric
- Keywords
- Labor epidural analgesia, Cesarean section, Instrumental delivery, Neonatal well-being
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,995 participants (actual)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 1 Oct 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant patients classified as Robson class 1, who received or not EA for labour and delivered either vaginally or via caesarean route.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- minimal duration of labour < 3 hours (from admission to the delivery suite to delivery)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Length of active phase
Time frame: Up to 24 hours from admission.
Length of second stage
Time frame: Up to 24 hours from admission.
Type of vaginal delivery
Time frame: At delivery
Maternal complications during vaginal delivery
Time frame: At delivery.
Episiotomy
Time frame: At delivery.
Fetal indicators
Time frame: After delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 29781504Anim-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.
- Background: PubMed 33837643de 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.
- Background: PubMed 16420344Vahratian 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.
- Background: PubMed 717493Friedman 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.
- Background: PubMed 12388957Zhang 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.
- Background: PubMed 21099592Zhang 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.
- Individual participant dataSharing planned: No. For patient's privacy protection.
Related trials for Epidural Analgesia, Obstetric
RecruitingObservational study
Anesthetic Technique and Quality of Recovery After Cesarean Delivery
Ceserean Section, Obstetric Quality of Recovery
Not yet recruitingPhase 4
Does the Volume of Medication Affect the Success of Labor Epidural Analgesia
Labor Pain and to Reduce Pain
Not yet recruitingObservational study
Perfusion Index Variability During Epidural Labor Analgesia
Labor Epidural Analgesia, Perfusion Index
RecruitingObservational study
Inertial Sensors for Obstetrical Walking Epidural Tracking
Pregnancy Related, Epidural; Anesthesia, Headache
Recruiting
Carbohydrate-Optimized Nutritional Solution Versus Electrolyte Hydration in Labor
Obstetric Labor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidural Analgesia, Obstetric, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cervical dilation curve (time frame: First stage of labour (from admission to the delivery suite to full cervical dilation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06987591, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.