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Comparison of manual-push loading versus programmed intermittent epidural bolus pump loading for labor analgesia: a randomized controlled non-inferiority study

Comparison of manual-push loading versus programmed intermittent epidural bolus pump loading for labor analgesia: a randomized controlled non-inferiority study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300074063
Enrollment
Unknown
Registered
2023-07-28
Start date
2023-07-28
Completion date
Unknown
Last updated
2023-07-30

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

Conditions

Labor analgesia

Interventions

one:manual push loading
two:PIEB pump machine pumping loading

Sponsors

Shanghai First Maternity and Infant Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: ASA grade II-III, gestational weeks > 37 weeks, 18y 5 (VAS 0-10, where 0 = no pain and 10 = worst pain imaginable) at the request of epidural analgesia were eligible.

Exclusion criteria

Exclusion criteria: Contraindication to spinal anesthesia (e.g., bleeding and coagulation disorders, allergy to local anesthetic drugs); accidental dural puncture; allergy to sufentanil, ropivacaine; receipt of opioids or sedation 4 h prior to labor analgesia, known fetal abnormalities, history of previous pelvic surgery, presence of pregnancy comorbidities.

Design outcomes

Primary

MeasureTime frame
the percentage of adequate labor analgesia after loading dose;

Secondary

MeasureTime frame
Sensory block level;incidence of motor block;incidence of hypotension;maternal satisfactory of labor analgesia;times of rescue epidural analgesics;the number of patient controlled epidural analgesia demand boluses;incidence of other side effects;Neonatal weight;Neonatal Apgar Score;

Countries

China

Contacts

Public ContactYan Lu

Shanghai First Maternity and Infant Hospital

aneyan_lu@163.com+86 131 6290 1723

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 5, 2026