Clinical trial NCT06886555: Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour
Official title: Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Labour Analgesia, Epidural Anaesthesia
Duration of Labour
Labor, Induced
Keywords: neuraxil analgesia
induced labour
Lead sponsor: Fondazione IRCCS Policlinico San Matteo di Pavia
Sponsor class: OTHER
First posted: 2025-03-20
Enrollment: 400
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with induced labour undergoing epidual analgesia

Brief summary: The aim of this observational study is to assess the effect of early labour analgesia on obstetric and neonatal outcomes in induced labour in primiparous women with a full-term pregnancy whose labour was induced with a Cook balloon or prostaglandins.

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).


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years;
* 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:

* Endouterine fetal death;
* Anhydramnios:
* Trial labour after caesarean section;
* Cardiotocogram class ≥2 before start of analgesia;
* Third trimester bleeding;
* Patient refusal;
* Inability to understand informed consent.

Primary outcomes:
measure: Duration of labour
timeFrame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Secondary outcomes:
measure: Incidence of operative deliveries
timeFrame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: Incidence of Episiotomy
timeFrame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: Incidence of caesarean section during labour
timeFrame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: Incidence of Obstetric lacerations
timeFrame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: Oxytocin consumption
timeFrame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: Peridural catheter repositioning
timeFrame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: Fetal heart rate abnormalities
timeFrame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: Apgar score
timeFrame: Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: pH Neonatal umbilical cord
timeFrame: Perioperative/Periprocedural. The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: Admission to neonatal intensive care unit
timeFrame: Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
measure: Administering a 'rescue' epidural analgesia
timeFrame: Perioperative/Periprocedural.The investigator traces the information examining the medical chart in a time frame from one day after birth until 6 month from study termination.
Other outcomes:
Locations:
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo, SC AR3 - Anestesia e Terapia Intensiva Postchirurgica
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.