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Search / Trial NCT06860854

Trial Information

Current as of July 04, 2025

Not yet recruiting

Keywords

Epidural Analgesia Uterine Contractility Maternal Fetal Hemodynamics Cardiotocography (Ctg) Patterns

ClinConnect Summary

This clinical trial, called "EPidural's Impact on Contractions and Fetal REsponse," is studying how epidural anesthesia, a common pain relief option during labor, affects uterine contractions and the well-being of the baby. The researchers want to understand how epidurals change the way the uterus contracts and how these changes relate to fetal heart rate and blood flow. They will recruit 200 women who are in labor and eligible for epidural pain relief to see how these factors change before and after the epidural is given. The study will also look at differences between first-time mothers and those who have given birth before, as well as between pregnancies that are considered normal and those with complications.

To participate in this trial, women need to be at least 18 years old, be having a single baby, and be in labor with their cervix open at least 3 centimeters. They also need to have a normal heart rate tracing for the baby at least 30 minutes before receiving the epidural and must sign a consent form agreeing to participate. Women who are not eligible include those under 18, having a premature baby, or those who have received certain treatments or have specific health concerns. If you join the study, you can expect to be monitored closely, and the findings will help improve our understanding of how epidurals affect labor and baby health.

Gender

FEMALE

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

About Central Clinical Hospital Of The Ministry Of Internal Affairs And Administration, Warsaw, Poland

The Central Clinical Hospital of the Ministry of Internal Affairs and Administration in Warsaw, Poland, is a leading medical institution dedicated to providing high-quality healthcare and advancing medical research. As a prominent clinical trial sponsor, the hospital engages in innovative studies aimed at improving patient outcomes and addressing critical health challenges. With a multidisciplinary team of experienced researchers and healthcare professionals, the hospital fosters a collaborative environment that prioritizes ethical standards and patient safety in clinical research. Its commitment to excellence and continuous improvement positions it as a key player in the advancement of medical science in Poland and beyond.

Locations

Warsaw, , Poland

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported