EPidural's Impact on Contractions and Fetal REsponse (EPI-CARE)

Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland

Status: Not yet enrolling

Conditions: Uterine Contraction; Doppler Ultrasound; Epidural Anesthesia in Labor and Delivery

Treatments: Procedure: Epidural Analgesia

Study type: Observational

Funder types: Other

Identifiers

NCT06860854

EPI-CARE ver. 1

Details and patient eligibility

About

This prospective observational study aims to assess the impact of epidural analgesia (ELA) on uterine contractility, cardiotocography (CTG) patterns, and maternal-fetal hemodynamics in term pregnancies. The study will recruit 200 laboring patient receiving ELA and evaluate changes in uterine contractions, Doppler blood flow parameters, and fetal heart rate tracings before and after ELA administration. Secondary analyses will compare outcomes between primiparous and multiparous women, as well as between uncomplicated and complicated pregnancies. Pain relief effectiveness will be correlated with observed changes. This study will provide a comprehensive understanding of ELA's effects on labor progression and fetal well-being, addressing gaps in existing research.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥ 18 years old
• singleton pregnancy
• signed informed consent form
• patients in labor
• cervical dilation ≥ 3cm,
• patient requesting and eligible for epidural analgesia
• normal CTG trace for at least 30 minutes before epidural analgesia

Exclusion criteria

• < than 18 years old
• preterm delivery
• labor induced or stimulated by oxytocin
• multiple pregnancy
• fetal malformations
• < than 3cm cervical dilation
• lack of CTG trace for at least 30 minutes before epidural analgesia
• patient not requesting or not eligible for epidural analgesia
• informed consent form not signed

Trial design

200 participants in 1 patient group

Patients in Labor

Description:

The study aims to recruit 200 patients in spontaneous or induced labor at 37-42 weeks of gestation, requesting the epidural labor analgesia (ELA) and meeting the inclusion criteria.

Treatment:

Procedure: Epidural Analgesia