Epidural Anesthesia in Labor and DeliveryEPI-CARENCT06860854
EPidural's Impact on Contractions and Fetal REsponse
An observational study of Epidural Anesthesia in Labor and Delivery and Doppler Ultrasound, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Epidural Anesthesia in Labor and Delivery, Doppler Ultrasound, Uterine Contraction
- What is being tested?
- Epidural Analgesia
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 200 participants
- Where
- 1 sitePoland
- Study dates
- 17 Mar 2025to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- ≥ 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
Who cannot join
- < than 18 years old
- preterm delivery
- labor induced or stimulated by oxytocin
- multiple pregnancy
- fetal malformations
- < than 3cm cervical dilation
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site
Clinical Department of Obstetrics and Perinatology at the National Medical Institute of the Ministry of the Interior and Administration
Warsaw, 02-507
Joanna W Król, MD, +48 601 780 625, krol.joann@gmail.com
About this study
Official title: The Effect of Epidural Analgesia on Uterine Contractility and Intrapartum Fetal Well-being - Study Protocol for a Prospective Observational Study "EPI-CARE"
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.
- Being tested
- Epidural Analgesia
- Keywords
- Epidural Analgesia, Uterine Contractility, Maternal-Fetal Hemodynamics, Cardiotocography (CTG) Patterns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epidural AnalgesiaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Epidural Analgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: From enrollment up to 120 minutes after the administration of epidural
Secondary outcomes (3)
Differences between primiparous and multiparous patients
The primary outcomes will be compared between primiparous and multiparous patients with the use of subgroup analyses.
Measured: From enrollment to 120 minutes after the administration of ELA
Differences between complicated and uncomplicated pregnancies
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.
Measured: 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
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.
Measured: From the enrollment up to 120 minutes after the administration of ELA
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start17 Mar 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Epidural Anesthesia in Labor and DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Król Joanna, Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860854
- Sponsor's protocol ID
- EPI-CARE ver. 1
- Acronym
- EPI-CARE
- Status last verified
- Feb 2025
- First submitted
- 25 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Epidural Analgesia on Uterine Contractility and Intrapartum Fetal Well-being - Study Protocol for a Prospective Observational Study "EPI-CARE"
- ClinicalTrials.gov ID
- NCT06860854
- Acronym / sponsor ID
- EPI-CARE / EPI-CARE ver. 1
- Keywords
- Epidural Analgesia, Uterine Contractility, Maternal-Fetal Hemodynamics, Cardiotocography (CTG) Patterns
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, PolandUniversity, hospital or other
- Study start
- 17 Mar 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in Labor | – | Procedure: Epidural AnalgesiaThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- ≥ 18 years old
- singleton pregnancy
- signed informed consent form
- patients in labor
- cervical dilation ≥ 3cm,
Key exclusion criteria (9 listed)
- < than 18 years old
- preterm delivery
- labor induced or stimulated by oxytocin
- multiple pregnancy
- fetal malformations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epidural AnalgesiaThe 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. | Procedure or surgery | Patients in Labor |
Primary outcome
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.
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.
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.
3 secondary outcomes
Differences between primiparous and multiparous patients
Time frame: From enrollment to 120 minutes after the administration of ELA
Differences between complicated and uncomplicated pregnancies
Time frame: 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
Time frame: From the enrollment up to 120 minutes after the administration of ELA
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epidural Anesthesia in Labor and Delivery and Doppler Ultrasound, run by Central Clinical Hospital of the Ministry of Internal Affairs and Administration, Warsaw, Poland at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joanna W Król, MD (+48 601 780 625, krol.joann@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in uterine contractility (time frame: From enrollment to 120 minutes after the administration of epidural analgesia). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.