Effect of Epidural Analgesia on Labour, Neonatal and Maternal Outcomes.

NCT05579808 | Completed

• 1 other identifier: 3741
• Study Type: observational
• Target: 21,808
• Locations: 1 country
• Sites: 1

Brief Summary

Lumbar epidural analgesia is the most used method for reducing labour pain, but its impact on the duration of the second stage of labour and on neonatal and maternal outcomes remains debated. The aim was of the study is to examine whether epidural analgesia affects the course and the outcomes of labour among patients divided according to the Robson-10 group classification system. Patients of Robson's classes 1, 2a, 3, and 4a were divided into either the epidural analgesia group or the non-epidural analgesia group. A propensity score matching analysis was performed to balance intergroup differences. The primary goal was to analyse the duration of the second stage of labour. The secondary goals were to evaluate neonatal and maternal outcomes.

Conditions

Labor Pain; Delivery Complication; Regional Anesthesia Morbidity

Keywords

Labor epidural analgesia

Outcome Measures

Primary Outcomes (1)

• Lenght of 2nd stage

  Evaluate the length of the second stage of labour

  From the time of the first documented full cervical dilatation to delivery

Secondary Outcomes (2)

• Foetal Outcome

  At 1 and 5 minutes after birth

• maternal outcome

  2 hours after the delivery.

Study Arms (2)

Epidural Analgesia

Procedure: Epidural Analgesia

No analgesia

Interventions

Epidural Analgesia PROCEDURE

Using an aseptic technique while the patient is in sitting position, an epidural catheter was placed at the L2-L3 or L3-L4 interspace. Analgesia was established with the epidural administration of a low dose of local anaesthetic, plus a lipid-soluble opioid (ropivacaine 0.1% and sufentanyl 0.5%, 20 mL). Analgesia was maintained with a top-up regimen, using intermittent manual epidural boluses of increasing concentrations of ropivacaine, with up to 0.15% at full dilation, according to specific needs of individual participants.

Epidural Analgesia

Eligibility Criteria

• Gender Eligibility Details: Pregnant women
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A retrospective cohort analysis was performed of all live, at term (37-42 weeks) vaginal deliveries at a tertiary university hospital over an 11-year period (October 2008 to October 2019). This population was divided according to the RTGCS. Pregnant patients were enrolled according to the following RTGCS groups: R1 (nulliparous, single cephalic full-term pregnancy with spontaneous labour); R2a (nulliparous, single cephalic full-term pregnancy with induced labour); R3 (multiparous, single cephalic full-term pregnancy with spontaneous labour); and R4a (multiparous, single cephalic full-term pregnancy with induced labour).

You may qualify if:

• pregnant women,
• at term (37-42 weeks),
• admitted to a tertiary university hospital over an 11-year period (October 2008 to October 2019)

You may not qualify if:

• multiple pregnancies,
• known major fetal or chromosomal abnormalities,
• pre-labour Caesarean deliveries,
• elective Caesarean deliveries.

Sponsors & Collaborators

• Fondazione Policlinico Universitario Agostino Gemelli IRCCS: lead

Study Sites (1)

IRCCS Policlinico Agostino Gemelli

Rome, 00168, Italy

Location

Related Publications (33)

• Shen X, Li Y, Xu S, Wang N, Fan S, Qin X, Zhou C, Hess PE. Epidural Analgesia During the Second Stage of Labor: A Randomized Controlled Trial. Obstet Gynecol. 2017 Nov;130(5):1097-1103. doi: 10.1097/AOG.0000000000002306.

  PMID: 29016499 BACKGROUND

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  PMID: 25824008 BACKGROUND

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  PMID: 29781504 RESULT

• Shmueli A, Salman L, Orbach-Zinger S, Aviram A, Hiersch L, Chen R, Gabbay-Benziv R. The impact of epidural analgesia on the duration of the second stage of labor. Birth. 2018 Dec;45(4):377-384. doi: 10.1111/birt.12355. Epub 2018 May 22.

  PMID: 29790194 RESULT

• Cheng YW, Shaffer BL, Nicholson JM, Caughey AB. Second stage of labor and epidural use: a larger effect than previously suggested. Obstet Gynecol. 2014 Mar;123(3):527-535. doi: 10.1097/AOG.0000000000000134.

  PMID: 24499753 RESULT

• Naito Y, Ida M, Yamamoto R, Tachibana K, Kinouchi K. The effect of labor epidural analgesia on labor, delivery, and neonatal outcomes: a propensity score-matched analysis in a single Japanese institute. JA Clin Rep. 2019 Jun 18;5(1):40. doi: 10.1186/s40981-019-0260-z.

  PMID: 32026970 RESULT

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  PMID: 27828798 RESULT

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  PMID: 24553167 RESULT

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  PMID: 21099592 RESULT

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  PMID: 26928148 RESULT

• ACOG Committee Opinion No. 766: Approaches to Limit Intervention During Labor and Birth. Obstet Gynecol. 2019 Feb;133(2):e164-e173. doi: 10.1097/AOG.0000000000003074.

  PMID: 30575638 RESULT

• O'Connell MP, Hussain J, Maclennan FA, Lindow SW. Factors associated with a prolonged second state of labour--a case-controlled study of 364 nulliparous labours. J Obstet Gynaecol. 2003 May;23(3):255-7. doi: 10.1080/0144361031000098361.

  PMID: 12850854 RESULT

• Carlhall S, Kallen K, Blomberg M. Maternal body mass index and duration of labor. Eur J Obstet Gynecol Reprod Biol. 2013 Nov;171(1):49-53. doi: 10.1016/j.ejogrb.2013.08.021. Epub 2013 Aug 29.

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• Bregand-White JM, Kominiarek M, Hibbard JU Consortium On Safe L. OS030. Hypertension and labor duration: Does it take longer? Pregnancy Hypertens. 2012 Jul;2(3):192. doi: 10.1016/j.preghy.2012.04.031. Epub 2012 Jun 13.

  PMID: 26105244 RESULT

• Ghi T, Maroni E, Youssef A, Morselli-Labate AM, Paccapelo A, Montaguti E, Rizzo N, Pilu G. Sonographic pattern of fetal head descent: relationship with duration of active second stage of labor and occiput position at delivery. Ultrasound Obstet Gynecol. 2014 Jul;44(1):82-9. doi: 10.1002/uog.13324. Epub 2014 May 28.

  PMID: 24496823 RESULT

• Moraloglu O, Kansu-Celik H, Tasci Y, Karakaya BK, Yilmaz Y, Cakir E, Yakut HI. The influence of different maternal pushing positions on birth outcomes at the second stage of labor in nulliparous women. J Matern Fetal Neonatal Med. 2017 Jan;30(2):245-249. doi: 10.3109/14767058.2016.1169525. Epub 2016 Apr 19.

  PMID: 27028537 RESULT

• Cheng YW, Hopkins LM, Laros RK Jr, Caughey AB. Duration of the second stage of labor in multiparous women: maternal and neonatal outcomes. Am J Obstet Gynecol. 2007 Jun;196(6):585.e1-6. doi: 10.1016/j.ajog.2007.03.021.

  PMID: 17547906 RESULT

• Gimovsky AC, Guarente J, Berghella V. Prolonged second stage in nulliparous with epidurals: a systematic review. J Matern Fetal Neonatal Med. 2017 Feb;30(4):461-465. doi: 10.1080/14767058.2016.1174999. Epub 2016 May 5.

  PMID: 27050812 RESULT

• Bannister-Tyrrell M, Ford JB, Morris JM, Roberts CL. Epidural analgesia in labour and risk of caesarean delivery. Paediatr Perinat Epidemiol. 2014 Sep;28(5):400-11. doi: 10.1111/ppe.12139. Epub 2014 Jul 18.

  PMID: 25040829 RESULT

• Zha Y, Gong X, Yang C, Deng D, Feng L, Luo A, Wan L, Qiao F, Zeng W, Chen S, Wu Y, Han D, Liu H. Epidural analgesia during labor and its optimal initiation time-points: A real-world study on 400 Chinese nulliparas. Medicine (Baltimore). 2021 Mar 5;100(9):e24923. doi: 10.1097/MD.0000000000024923.

  PMID: 33655955 RESULT

• Ravelli ACJ, Eskes M, de Groot CJM, Abu-Hanna A, van der Post JAM. Intrapartum epidural analgesia and low Apgar score among singleton infants born at term: A propensity score matched study. Acta Obstet Gynecol Scand. 2020 Sep;99(9):1155-1162. doi: 10.1111/aogs.13837. Epub 2020 Mar 20.

  PMID: 32142154 RESULT

• Laughon SK, Berghella V, Reddy UM, Sundaram R, Lu Z, Hoffman MK. Neonatal and maternal outcomes with prolonged second stage of labor. Obstet Gynecol. 2014 Jul;124(1):57-67. doi: 10.1097/AOG.0000000000000278.

  PMID: 24901265 RESULT

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  PMID: 11359322 RESULT

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• Wang Q, Zheng SX, Ni YF, Lu YY, Zhang B, Lian QQ, Hu MP. The effect of labor epidural analgesia on maternal-fetal outcomes: a retrospective cohort study. Arch Gynecol Obstet. 2018 Jul;298(1):89-96. doi: 10.1007/s00404-018-4777-6. Epub 2018 May 18.

  PMID: 29777348 RESULT

• La Camera G, La Via L, Murabito P, Pitino S, Dezio V, Interlandi A, Minardi C, Astuto M. Epidural analgesia during labour and stress markers in the newborn. J Obstet Gynaecol. 2021 Jul;41(5):690-692. doi: 10.1080/01443615.2020.1755621. Epub 2020 Jun 4.

  PMID: 32496840 RESULT

• de Barros Duarte L, Moises EC, Carvalho Cavalli R, Lanchote VL, Duarte G, da Cunha SP. Distribution of fentanyl in the placental intervillous space and in the different maternal and fetal compartments in term pregnant women. Eur J Clin Pharmacol. 2009 Aug;65(8):803-8. doi: 10.1007/s00228-009-0645-4. Epub 2009 Mar 28.

  PMID: 19330322 RESULT

• Zhang L, Xu C, Li Y. Impact of epidural labor analgesia using sufentanil combined with low-concentration ropivacaine on maternal and neonatal outcomes: a retrospective cohort study. BMC Anesthesiol. 2021 Sep 22;21(1):229. doi: 10.1186/s12871-021-01450-2.

  PMID: 34551718 RESULT

• Antonakou A, Papoutsis D. The Effect of Epidural Analgesia on the Delivery Outcome of Induced Labour: A Retrospective Case Series. Obstet Gynecol Int. 2016;2016:5740534. doi: 10.1155/2016/5740534. Epub 2016 Nov 20.

  PMID: 27990163 RESULT

• Srebnik N, Barkan O, Rottenstreich M, Ioscovich A, Farkash R, Rotshenker-Olshinka K, Samueloff A, Grisaru-Granovsky S. The impact of epidural analgesia on the mode of delivery in nulliparous women that attain the second stage of labor. J Matern Fetal Neonatal Med. 2020 Jul;33(14):2451-2458. doi: 10.1080/14767058.2018.1554045. Epub 2019 Jan 4.

  PMID: 30608007 RESULT

• Simic M, Cnattingius S, Petersson G, Sandstrom A, Stephansson O. Duration of second stage of labor and instrumental delivery as risk factors for severe perineal lacerations: population-based study. BMC Pregnancy Childbirth. 2017 Feb 21;17(1):72. doi: 10.1186/s12884-017-1251-6.

  PMID: 28222704 RESULT

• Fritel X, Schaal JP, Fauconnier A, Bertrand V, Levet C, Pigne A. Pelvic floor disorders 4 years after first delivery: a comparative study of restrictive versus systematic episiotomy. BJOG. 2008 Jan;115(2):247-52. doi: 10.1111/j.1471-0528.2007.01540.x. Epub 2007 Oct 25.

  PMID: 17970794 RESULT

• Webb DA, Culhane J. Hospital variation in episiotomy use and the risk of perineal trauma during childbirth. Birth. 2002 Jun;29(2):132-6. doi: 10.1046/j.1523-536x.2002.00173.x.

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MeSH Terms

Conditions

Labor Pain

Interventions

Analgesia, Epidural

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2022
• First Posted: October 14, 2022
• Study Start: June 1, 2021
• Primary Completion: July 1, 2021
• Study Completion: September 1, 2021
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)