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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | From enrollment up to 120 minutes after the administration of epidural |
| Measure | Description | Time Frame |
|---|---|---|
| Differences between primiparous and multiparous patients | The primary outcomes will be compared between primiparous and multiparous patients with the use of subgroup analyses. | From enrollment to 120 minutes after the administration of ELA |
| Differences between complicated and uncomplicated pregnancies |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Joanna W Król, MD | Contact | +48 601 780 625 | krol.joann@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinical Department of Obstetrics and Perinatology at the National Medical Institute of the Ministry of the Interior and Administration | Warsaw | 02-507 | Poland |
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| ID | Term |
|---|---|
| D015360 | Analgesia, Epidural |
| ID | Term |
|---|---|
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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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. |
| 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. | From the enrollment up to 120 minutes after the administration of ELA |