Clinical trial NCT06860854: EPidural's Impact on Contractions and Fetal REsponse
Official title: The Effect of Epidural Analgesia on Uterine Contractility and Intrapartum Fetal Well-being - Study Protocol for a Prospective Observational Study "EPI-CARE"
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Epidural Anesthesia in Labor and Delivery
Doppler Ultrasound
Uterine Contraction
Keywords: Epidural Analgesia
Uterine Contractility
Maternal-Fetal Hemodynamics
Cardiotocography (CTG) Patterns
Lead sponsor: Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
Sponsor class: OTHER
First posted: 2025-03-06
Enrollment: 200
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: 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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in uterine contractility
timeFrame: From enrollment to 120 minutes after the administration of epidural analgesia
measure: Changes in maternal and fetal doppler velocities
timeFrame: From enrollment to 24 hours after labor
measure: Changes in cardiotocography (CTG) patterns
timeFrame: From enrollment up to 120 minutes after the administration of epidural
Secondary outcomes:
measure: Differences between primiparous and multiparous patients
timeFrame: From enrollment to 120 minutes after the administration of ELA
measure: Differences between complicated and uncomplicated pregnancies
timeFrame: From enrollment up to 120 minutes after the administration of ELA
measure: The correlation of pain relief with changes in uterine contractility and maternal-fetal hemodynamics
timeFrame: From the enrollment up to 120 minutes after the administration of ELA
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Clinical Department of Obstetrics and Perinatology at the National Medical Institute of the Ministry of the Interior and Administration
Study officials:
References: