Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour
NCT ID: NCT06886555
Last Updated: 2025-03-20
Study Results
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Basic Information
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COMPLETED
400 participants
OBSERVATIONAL
2022-10-21
2024-12-19
Brief Summary
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It aims to answer whether early labour analgesia (\< 4 centimetres of cervical dilation) prolongs the duration of labour. Secondary outcomes will be Incidence of caesarean section, use of oxytocin, onset of fetal heart rate abnormalities within 30 minutes of augmentation, incidence of episiotomy, amount of blood loss, need for epidural catheter repositioning due to inadequate analgesia, onset of breakthrough pain defined as need for "rescue" top-ups within 60 minutes of previous top-ups, Apgar score (at 1 and 5 minutes), neonatal umbilical pH and neonatal intensive care unit admission. Patients who received early partoanalgesia were compared for the proposed outcomes with patients who received partoanalgesia in active labour (cervical dilation \> 4 centimetres).
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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women undergoing labour induction
Epidural analgesia for labour pain
Patients were divided into two groups according to repertorised cervical dilatation at the start of analgesia: Group A \< 4 centimetres (latent stage according to National Institute for Health and Care Excellence guidelines) and Group B between 4 and 6 centimetres.
Interventions
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Epidural analgesia for labour pain
Patients were divided into two groups according to repertorised cervical dilatation at the start of analgesia: Group A \< 4 centimetres (latent stage according to National Institute for Health and Care Excellence guidelines) and Group B between 4 and 6 centimetres.
Eligibility Criteria
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Inclusion Criteria
* Primipara;
* Single pregnancy;
* Gestational age \> 36 weeks;
* Induced labour with Bishop Score \< 6;
* Cervical dilatation at start of analgesia ≤ 6 cm;
* ASA Class 2.
Exclusion Criteria
* Anhydramnios:
* Trial labour after caesarean section;
* Cardiotocogram class ≥2 before start of analgesia;
* Third trimester bleeding;
* Patient refusal;
* Inability to understand informed consent.
18 Years
FEMALE
No
Sponsors
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Fondazione IRCCS Policlinico San Matteo di Pavia
OTHER
Responsible Party
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Silvia Poma
Medical doctor- Principal Investigator
Locations
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Fondazione IRCCS Policlinico San Matteo, SC AR3 - Anestesia e Terapia Intensiva Postchirurgica
Pavia, Pavia, Italy
Countries
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References
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Simpson KR. Cervical Ripening and Labor Induction and Augmentation, 5th Edition. Nurs Womens Health. 2020 Aug;24(4):S1-S41. doi: 10.1016/j.nwh.2020.04.005.
Wong CA, McCarthy RJ, Sullivan JT, Scavone BM, Gerber SE, Yaghmour EA. Early compared with late neuraxial analgesia in nulliparous labor induction: a randomized controlled trial. Obstet Gynecol. 2009 May;113(5):1066-1074. doi: 10.1097/AOG.0b013e3181a1a9a8.
Ohel G, Gonen R, Vaida S, Barak S, Gaitini L. Early versus late initiation of epidural analgesia in labor: does it increase the risk of cesarean section? A randomized trial. Am J Obstet Gynecol. 2006 Mar;194(3):600-5. doi: 10.1016/j.ajog.2005.10.821.
Sng BL, Sia ATH. Maintenance of epidural labour analgesia: The old, the new and the future. Best Pract Res Clin Anaesthesiol. 2017 Mar;31(1):15-22. doi: 10.1016/j.bpa.2017.01.002. Epub 2017 Jan 12.
Other Identifiers
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TAIL
Identifier Type: -
Identifier Source: org_study_id
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