Skip to content

A Biased-Coin Up-and-Down Sequential Allocation Trial to Determine the Optimum Epidural Loading Dose with Dural Puncture Epidural Technique for Labor Analgesia

A Biased-Coin Up-and-Down Sequential Allocation Trial to Determine the Optimum Epidural Loading Dose with Dural Puncture Epidural Technique for Labor Analgesia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074502
Enrollment
Unknown
Registered
2023-08-08
Start date
2023-08-08
Completion date
Unknown
Last updated
2023-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

labor pain

Interventions

Group 12:epidural loading dose:12 mL
Group 14:epidural loading dose:14 mL
Group 16:epidural loading dose:16 mL
Group 18:epidural loading dose:18 mL
Group 20:epidural loading dose:20 mL

Sponsors

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. ASA II to III, more than 37 weeks of gestation; 2. 20 years old =5 (NRS 0 to 10, where 0= no pain and 10= the most severe pain imaginable) are eligible for epidural analgesia.

Exclusion criteria

Exclusion criteria: 1. Morbid obesity; 2. Complications of pregnancy such as gestational diabetes mellitus, gestational hypertension, gestational heart disease, preeclampsia, etc.; 3. Drug abuse history 4. spinal anesthesia contraindications (such as coagulopathy, local anesthesia drug allergy, etc.); 5. The presence of conditions that increase the risk of caesarean section (such as placenta previa, uterine malformations); 6. Received opiates or sedatives 4 hours before labor pain relief; 7. Known fetal abnormalities; 8. other conditions: patients with epidural needle accident dura puncture, no cerebrospinal fluid reflux after DPE or completion of labor within 1 hour after the start of epidural labor analgesia will also be excluded from the study.

Design outcomes

Primary

MeasureTime frame
effective labor analgesia;

Secondary

MeasureTime frame
Numerical Rating Score for pain;sensory block level;Bromage score;adverse events;Neonatal weight;Neonatal Apgar Score;

Countries

China

Contacts

Public ContactSong Yujie

Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

songyujie@51mch.com+86 137 6197 1889

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026