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Effect of Dexmedetomidine-Assisted Epidural Labor Analgesia on Early Postpartum Depression (PPD) in Puerperae: The Mediating Role of Early Postpartum Sleep Quality

Effect of Dexmedetomidine-Assisted Epidural Labor Analgesia on Early Postpartum Depression (PPD) in Puerperae: The Mediating Role of Early Postpartum Sleep Quality

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500115774
Enrollment
Unknown
Registered
2025-12-31
Start date
2026-01-01
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

postpartum depression

Interventions

Experimental group:0.1% ropivacaine +0.4µg/mL dexmedetomidine
Control group:0.125% ropivacaine

Sponsors

Linping District Women and Children Care Hospital
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: 1. Women aged 18-40 years, classified as ASA II, with a singleton full-term pregnancy; 2. Women in labor with a Numeric Rating Scale of Pain (NRS) score >=6 who are planning to undergo epidural labor analgesia; 3. Able to complete the questionnaire successfully and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. A clear history of mental health disorders (such as depression, schizophrenia, etc.) or sleep disorders (such as insomnia, sleep apnea, etc.) before pregnancy, or the use of analgesics, sedatives, or antidepressants; 2. Cognitive impairment or communication disorders; 3. Severe pregnancy complications during pregnancy (such as severe preeclampsia, placenta accreta, HELLP syndrome, placenta previa, placental abruption), combined with serious organ dysfunction of the heart, lungs, liver, kidneys, or endocrine diseases, or ASA classification >= III; 4. Contraindications to epidural labor analgesia (including but not limited to platelet abnormalities or coagulation disorders, malformations or infections at the puncture site, etc.); 5. Contraindications to dexmedetomidine (such as hypotension, heart rate <60 beats/min, cardiac conduction block, heart failure, allergy to dexmedetomidine or its components, etc.); 6. History of opioid or other sedative use within 4 hours before epidural labor analgesia; 7. Severe fetal malformations or stillbirth; 8. Improper use of epidural labor analgesia drugs for any reason (such as catheter dislodgement not detected in time, early pump discontinuation during labor, etc.); 9. Accidental dural puncture during the procedure or need for emergency cesarean section; 10. Others deemed unsuitable to participate in the study or who refuse to participate.

Design outcomes

Primary

MeasureTime frame
PSQS score on the first day after delivery;EPDS score on the 42 days after delivery;

Secondary

MeasureTime frame
ISI score on the first day after delivery;PSQS score on the third day after delivery;PSQS score on the 7th day after delivery;PSQS score on the 14th day after delivery;PSQS score on the 42 days after delivery;ISI score on the third day after delivery;ISI score on the 7th day after delivery;ISI score on the 14th day after delivery;ISI score on the 42 days after delivery;The correlation between the PSQS scores at different time points postpartum and the EPDS scores on the 42 days postpartum;Total sleep time on the first day after delivery;Total sleep time on the third day after delivery;Deep sleep time on the first day after delivery;Deep sleep time on the third day after delivery;Light sleep time on the first day after delivery;Light sleep time on the third day after delivery;The rapid eye movement sleep time on the first day after delivery;The rapid eye movement sleep time on the third day after delivery;The number and duration of awakenings on the first day after childbirth;The number and duration of awakenings on the thirdt day after childbirth;SAS score on the 42 days after delivery;Newborn's 1-minute Apgar score;Newborn's 5-minute Apgar score;Umbilical artery pH value;The occurrence of adverse events within 2 days after childbirth;The time of the first walk after childbirth;Postpartum hospital stay;The occurrence of complications among postpartum women within 42 days after giving birth;The occurrence rate of neonatal complications within 42 days after childbirth;Postpartum breastfeeding situation;

Countries

China

Contacts

Public ContactLi Xing

Linping District Women and Children Care Hospital

xingli1114@126.com+86 177 8859 1069

Outcome results

None listed

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