Comparing two methods of pain relief during labor
Comparison of Standard Epidural and Dural Puncture Epidural Techniques in Labor Analgesia
This study is testing if a new way of giving epidurals during labor can provide better pain relief compared to the standard method for women in labor.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 20 Years to 45 Years |
| Sex | Female |
| Sponsor | Medipol University Academic / other |
| Locations | 1 site (Istanbul) |
| Trial ID | NCT06849726 on ClinicalTrials.gov |
What this trial studies
This study aims to compare the effectiveness of standard epidural analgesia with a newer technique called dural puncture epidural (DPE) during labor. The DPE method involves puncturing the dura with a spinal needle before placing the epidural catheter, which may enhance the spread of pain relief medication. The primary goal is to evaluate how well each method achieves adequate pain control, measured by patient-reported pain scores. Secondary objectives include assessing hemodynamic changes and fetal heart rate alterations during labor.
Who should consider this trial
Good fit: Ideal candidates for this study are nulliparous women at least 36 weeks pregnant, in active labor, and opting for a pain-free vaginal delivery.
Not a fit: Patients with pregnancy-related diseases or contraindications to neuraxial block may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved pain management options for women during labor.
How similar studies have performed: While the DPE technique is relatively novel, existing studies suggest it may enhance epidural analgesia effectiveness, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Nulliparous women * Gestational age of ≥36 weeks with vertex presentation * In active labor with cervical dilation ≤5 cm * Electing for a pain-free vaginal delivery with one of the two epidural analgesia methods * Provision of written informed consent Exclusion Criteria: * Presence of pregnancy-related diseases (e.g., preeclampsia, gestational diabetes) * Contraindications to neuraxial block * Risk factors for cesarean delivery (e.g., uterine anomalies, previous surgeries, morbid obesity) * Known fetal anomalies
Where this trial is running
Istanbul
- Medipol University — Istanbul, Turkey (Recruiting)
Study contacts
- Study coordinator: Burak Ömür
- Email: bomur@medipol.edu.tr
- Phone: +90 505 6215056
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.