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Recruiting NCT07395934

NCT07395934 Comparing PIEB and CEI for Labor Pain Relief

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Clinical Trial Summary
NCT ID NCT07395934
Status Recruiting
Phase
Sponsor Da Nang Family General Hospital
Condition Labor Pain
Study Type INTERVENTIONAL
Enrollment 60 participants
Start Date 2025-07-30
Primary Completion 2026-08-30

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 40 Years
Study Type INTERVENTIONAL
Interventions
PIEB + PCEACEI + PCEA

Eligibility Fast-Check

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What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 60 participants in total. It began in 2025-07-30 with a primary completion date of 2026-08-30.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

The purpose of this randomized controlled trial is to compare the efficacy and safety of two epidural analgesia maintenance methods for labor pain relief: Programmed Intermittent Epidural Bolus (PIEB) and Continuous Epidural Infusion (CEI), both combined with Patient-Controlled Epidural Analgesia (PCEA). The study aims to evaluate which technique provides superior analgesia while minimizing anesthetic consumption and preserving maternal motor function. A total of 60 parturients at Family Hospital, Da Nang, will be randomly assigned to either the PIEB or CEI group. Outcomes including pain intensity (VAS scores), total drug consumption, maternal satisfaction, and neonatal Apgar scores will be assessed.

Eligibility Criteria

Inclusion Criteria: * Parturients indicated for labor analgesia for vaginal delivery via epidural anesthesia. * Age from 18 to 40 years. * Physical status: ASA II. * Singleton pregnancy, full-term, vertex presentation in labor. * Indication for vaginal delivery. * No contraindications to epidural anesthesia. * Agreement to participate in the research and signed written informed consent. Exclusion Criteria: * Contraindications to epidural analgesia. * History of allergy to local anesthetics (Ropivacaine) or opioids (Fentanyl). * High-risk pregnancies: Preeclampsia, placenta previa, placental abruption. * Fetal distress or fetal abnormalities. * Chronic use of analgesic drugs or neurological/psychiatric disorders. * Parturients who refuse to participate or request to withdraw from the research.

Frequently Asked Questions

Who can join the NCT07395934 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 40 Years, studying Labor Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07395934 currently recruiting?

Yes, NCT07395934 is actively recruiting participants. Visit ClinicalTrials.gov or contact Da Nang Family General Hospital to inquire about joining.

Where is the NCT07395934 trial being conducted?

This trial is being conducted at Da Nang, Vietnam.

Who is sponsoring the NCT07395934 clinical trial?

NCT07395934 is sponsored by Da Nang Family General Hospital. The trial plans to enroll 60 participants.

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