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NCT Number: NCT06860854

EPidural's Impact on Contractions and Fetal REsponse

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.

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Key information

Conditions

Epidural Anesthesia in Labor and Delivery Doppler Ultrasound Uterine Contraction

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

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

Warsaw, 02-507, Poland

Location contact

Joanna W Król, MD

CONTACT

[email protected]

+48 601 780 625

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Changes in uterine contractility

    Time frame: From enrollment to 120 minutes after the administration of epidural analgesia

    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.

  2. Changes in maternal and fetal doppler velocities

    Time frame: From enrollment to 24 hours after labor

    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.

  3. Changes in cardiotocography (CTG) patterns

    Time frame: From enrollment up to 120 minutes after the administration of epidural

    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.

Secondary outcomes

  1. Differences between primiparous and multiparous patients

    Time frame: From enrollment to 120 minutes after the administration of ELA

    The primary outcomes will be compared between primiparous and multiparous patients with the use of subgroup analyses.

  2. Differences between complicated and uncomplicated pregnancies

    Time frame: From enrollment up to 120 minutes after the administration of ELA

    The subgroup analyses will help to determine whether the changes in primary outcomes differ between normal pregnancies and those complicated with diabetes mellitus, hypertension etc.

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

    Time frame: From the enrollment up to 120 minutes after the administration of ELA

    The pain relief will be measured comparing the difference between scores on the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain possible) before and after the use of epidural analgesia. Then using the primary outcomes we will study whether the pain relief correlates with the changes in uterine contractility and maternal-fetal doppler velocities.

Study contacts

Contact information is provided by the study sponsor or research team.

Joanna W Król, MD

CONTACT

[email protected]

+48 601 780 625

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

The Effect of Epidural Analgesia on Uterine Contractility and Intrapartum Fetal Well-being - Study Protocol for a Prospective Observational Study "EPI-CARE"

Acronym: EPI-CARE

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Mar 6, 2025
Registry last updated
Mar 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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