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

NCT ID: NCT06987591

Last Updated: 2025-05-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

5995 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-01

Study Completion Date

2025-05-01

Brief Summary

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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)

Detailed Description

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Conditions

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Epidural Analgesia, Obstetric

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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VD-e

Women who vaginally delivered and received EA for labour.

No interventions assigned to this group

VD-n

Women who vaginally delivered and did not receive EA for labour.

No interventions assigned to this group

CD-e

Women who delivered via intrapartum caesarean section and received EA for labour.

No interventions assigned to this group

CD-n

Women who delivered via intrapartum caesarean section and did not receive EA for labour.

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fondazione Policlinico Universitario Agostino Gemelli IRCCS

OTHER

Sponsor Role lead

Responsible Party

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ZANFINI BRUNO ANTONIO

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Fondazione Policlinico Universitario A. Gemelli IRCCS

Rome, RM, Italy

Site Status

Countries

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Italy

References

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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.

Reference Type BACKGROUND
PMID: 29781504 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 33837643 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16420344 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 717493 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12388957 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21099592 (View on PubMed)

Other Identifiers

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6077

Identifier Type: -

Identifier Source: org_study_id

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