Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Epidural anesthesia is used to relieve labour pain which helps reduce labour stress, increase comfort and improve cooperation with medical personnel. Administering opioid into the epidural space before cervical dilation of 4cm in the primigravida or 3cm in the multiparous can effectively reduce the pain levels with no effect on the labour progress. The aim of the study is to compare different opioids administered in this early labour stage.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fentanyl | Active Comparator | 100mcg Fentanyl administered into epidural space during regular contractions before cervical dilation |
|
| Sufentanyl | Active Comparator | 10mcg sufentanyl administered into the epidural space during regular contractions before cervical dilation |
|
| Control | No Intervention | No epidural analgesia |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fentanyl | Drug | 100mcg Fentanyl |
| |
| Sufentanil |
| Measure | Description | Time Frame |
|---|---|---|
| Pain intensity according to Numerical Rating Scale (NRS) | till 4cm cervical dilation in primigravida or 3cm multiparous | up to 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Fetal heart rate | till 4cm cervical dilation in primigravida or 3cm multiparous | up to 24 hours |
| Blood pressure parturient | till 4cm cervical dilation in primigravida or 3cm multiparous |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jan Bilawicz, MD | Contact | 0048225830381 | bilawicz@wp.pl |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Uniwersyteckie Centrum Zdrowia Kobiety i Noworodka, WUM | Recruiting | Warsaw | Masovian Voivodeship | 02-015 | Poland |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D005283 | Fentanyl |
| D017409 | Sufentanil |
| ID | Term |
|---|---|
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Participant not aware of opioid administered
| Drug |
10mcg sufentanil |
|
| up to 24 hours |
| Heart rate of parturient | till 4cm cervical dilation in primigravida or 3cm multiparous | up to 24 hours |