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Effect of hydromorphone epidural labor analgesia on postpartum sleep disorders

Effect of hydromorphone epidural labor analgesia on postpartum sleep disorders

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110125
Enrollment
Unknown
Registered
2025-09-30
Start date
2025-10-01
Completion date
Unknown
Last updated
2025-10-06

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

Conditions

Postpartum sleep disorder

Interventions

control group:Labor analgesia with 1mg/ml ropivacaine
Hydromorphone 0.015mg/ml group:Hydromorphone assisted epidural labor analgesia

Sponsors

Women's Hospital School of Medicine Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 50 Years

Inclusion criteria

Inclusion criteria: 1. Age 20~50 years old 2.BMI 18.5~30 3. American Society of Anesthesiologists (ASA) Class II 4. Women who are full-term (>=37 weeks old), singleton, spontaneous childbirth, and contraction pain (NRS>=3 points) who require epidural delivery analgesia. 5. None of the mothers had electrolyte disorders, infections, immunity, or severe endocrine system diseases.

Exclusion criteria

Exclusion criteria: The patients were complicated with mental disease, central nervous system disease, liver disease, renal dysfunction and cardiopulmonary dysfunction; Have sleep disorders (such as insomnia, sleep apnea, etc.); There were severe obstetric complications and complications such as preeclampsia and eclampsia, pregnancy induced hypertension, placenta previa, placental abruption; Stillbirth, stillbirth, neonatal malformation; There are contraindications to hydromorphone use (such as those allergic to hydromorphone and hydromorphone salt; those with respiratory depression; those with severe or acute bronchial asthma; and those at risk of gastrointestinal obstruction); Contraindications to spinal anesthesia; Abnormal coagulation function; Severe hypovolemia and hemodynamic instability; Taking anticoagulant drugs; Taking cardiovascular drugs, non steroidal anti-inflammatory drugs, hormone drugs, antipsychotic drugs, anti anxiety drugs, antidepressants with sedative effect, etc. in the near future; And the pregnant women who refused to participate.

Design outcomes

Primary

MeasureTime frame
Incidence of sleep disorders on the first day after delivery;

Secondary

MeasureTime frame
numerical rating scale;the score of pittsburgh sleep quality index;the score of Pain numerical rating scale; Anxiety ;Incidence of sleep disorders on the 2nd and 3rd day after delivery;Ramsay ;Insomnia severity;Depression;

Countries

China

Contacts

Public ContactLili Xu

Women's Hospital School of Medicine Zhejiang University

xulili@zju.edu.cn+86 182 6814 4502

Outcome results

None listed

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