Impact of Timing of Neuraxial Analgesia on Obstetric, Anesthesiologic and Neonatal Outcomes in Induced Labour (TAIL)

Institute of Hospitalization and Scientific Care (IRCCS)

Status: Completed

Conditions: Labor, Induced; Labour Analgesia, Epidural Anaesthesia; Duration of Labour

Treatments: Procedure: Epidural analgesia for labour pain

Study type: Observational

Funder types: Other

Identifiers

NCT06886555

TAIL

Details and patient eligibility

About

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).

Enrollment: 400 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

400 participants in 1 patient group

women undergoing labour induction

Treatment:

Procedure: Epidural analgesia for labour pain