Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
200 participants
OBSERVATIONAL
2025-03-17
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Epidural Analgesia
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.
Interventions
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Epidural Analgesia
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
OTHER
Responsible Party
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Król Joanna
Principal Investigator
Locations
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Clinical Department of Obstetrics and Perinatology at the National Medical Institute of the Ministry of the Interior and Administration
Warsaw, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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EPI-CARE ver. 1
Identifier Type: -
Identifier Source: org_study_id
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