EPidural's Impact on Contractions and Fetal REsponse

NCT06860854 | Not Yet Recruiting

• 1 other identifier: EPI-CARE ver. 1
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Epidural Analgesia; Uterine Contractility; Maternal-Fetal Hemodynamics; Cardiotocography (CTG) Patterns

Outcome Measures

Primary Outcomes (3)

• Changes in uterine contractility

  Uterine activity will be monitored using the external tocography and expressed as number of contractions per 10 minutes. Due to known limitations of the external tocography the labor progression, defined as the change in cervical dilation between the two vaginal examinations (the patients will be examined just before the administration of epidural analgesia and two hours after) will also be recorded in cm.

  From enrollment to 120 minutes after the administration of epidural analgesia

• Changes in maternal and fetal doppler velocities

  The pulsatility index (PI) of maternal uterine arteries, umbilical artery and fetal middle cerebral artery will be assessed by ultrasound before and 30, 60 and 120 minutes after the administration of epidural analgesia. Additionally, the PI in maternal uterine artery will be measured within first 24 hours after labor.

  From enrollment to 24 hours after labor

• Changes in cardiotocography (CTG) patterns

  CTG patterns will be monitored using the external tocography. The change in CTG patterns after the administration of epidural analgesia will be assessed by experts overlooking the study and they will be labeled as normal, suspicious or pathological using the FIGO guidelines.

  From enrollment up to 120 minutes after the administration of epidural

Secondary Outcomes (3)

• Differences between primiparous and multiparous patients

  From enrollment to 120 minutes after the administration of ELA

• Differences between complicated and uncomplicated pregnancies

  From enrollment up to 120 minutes after the administration of ELA

• The correlation of pain relief with changes in uterine contractility and maternal-fetal hemodynamics

  From the enrollment up to 120 minutes after the administration of ELA

Study Arms (1)

Patients in Labor

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.

Procedure: Epidural Analgesia

Interventions

Epidural Analgesia PROCEDURE

The eligible patients will have their vital signs (blood pressure, saturation, heart rate) and the Doppler velocities in the uterine arteries, umbilical artery and the fetal middle cerebral artery measured directly before the administration of ELA. They will be also asked to rate their level of pain on the visual analogue scale (VAS). The specific method and drug regimen for ELA will be determined by the attending anesthesiologist. The mode of administration (continuous infusion, intermittent bolus, or patient-controlled epidural analgesia) will be recorded along with the anesthetic agents used for future subgroup analysis. The vital signs, the Doppler velocities and VAS score will be recorded after 30, 60 and 120 minutes. After 2 hours the patients will be examined to assess the progress of labor.

Patients in Labor

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The patient in labor admitted to the Clinical Department of Obstetrics and Perinatology at the National Medical Institute of the Ministry of the Interior and Administration in Warsaw, Poland and meeting the inclusion criteria.

You may qualify if:

• ≥ 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

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

Study Sites (1)

Clinical Department of Obstetrics and Perinatology at the National Medical Institute of the Ministry of the Interior and Administration

Warsaw, 02-507, Poland

Location

MeSH Terms

Interventions

Analgesia, Epidural

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Central Study Contacts

Joanna W Król, MD

CONTACT

+48 601 780 625; krol.joann@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 25, 2025
• First Posted: March 6, 2025
• Study Start: March 17, 2025
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: March 6, 2025

Record last verified: 2025-02

Locations

PL (1)