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Evaluation of effect of dural puncture epidural technique combined with programmed intermittent epidural bolus technique in labor analgesia

Evaluation of effect of dural puncture epidural technique combined with programmed intermittent epidural bolus technique in labor analgesia: A single-center, prospective, randomized, double-blind, parallel-controlled, superior clinical trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900024205
Enrollment
Unknown
Registered
2019-06-30
Start date
2019-07-01
Completion date
Unknown
Last updated
2019-07-01

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

Conditions

labor analgesia

Interventions

experimental group :Use dural puncture epidural technique combined with programmed intermittent epidural bolus technique in labor analgesia
control group:Use epidural technique combined with programmed intermittent epidural bolus technique in labor analgesia

Sponsors

Shenzhen Maternity and Child Healthcare Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Nulliparous women with singleton, vertex presentation fetuses at 37 to 42 weeks'gestation in active labor with cervical dilatation 3-4cm and plan to request labor analgesia, BMI<30kg/m2, ASAI-II, no opioids were used in the past three months and no analgesics were accepted before labor active.

Exclusion criteria

Exclusion criteria: Women with contraindication to neuraxial analgesia techniques, with diseases of pregnancy (eg, gestation hypertension, preeclaimpsia, or gestation diabetes), known fetal anomalies, or conditions associated with an increased risk of cesarean delivery (eg, vaginal birth after cesarean delivery, history of uterine rupture), NPRS<5 in the presence of contraction, allergy to the drugs which we use in this test,septicemia, drug abuse and migraine were reported before this test.

Design outcomes

Primary

MeasureTime frame
percentage of parturients in each group with Numerical Pain Rating Scale (NPRS) =1 within 10 min after initial dosing;

Secondary

MeasureTime frame
the time to the adequate analgesia (min);time to the first top-up;number of physcian top-up interventions;sensory block;motor block;the percentage of low fetal heart rate;Apgar score of the fetal (1min, 5min);the mode of delivery;the percentage of adverse effects;the percentage of headache after delivery;the percentage of adverse effects about neuraxial analgesia after delivery;the satisfaction score of labor analgesia;

Countries

China

Contacts

Public ContactDaili Chen

Shenzhen Maternity and Child Healthcare Hospital

happy-99@163.com+86 13500052565

Outcome results

None listed

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