Intranasal Dexmedetomidine for Prevention of Intrapartum Fever

NCT07501221 | Not Yet Recruiting

• 1 other identifier: 202509
• Study Type: interventional
• Target: 446
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Title: Intranasal Dexmedetomidine for Prevention of Intrapartum Fever This study aims to evaluate the effect of intranasal dexmedetomidine (Dex) administered before neuraxial labor analgesia on the incidence of intrapartum fever in women undergoing vaginal delivery. This prospective, randomized, double-blind, placebo-controlled trial will enroll 446 parturients scheduled for vaginal delivery with neuraxial labor analgesia at Chengdu Jinjiang Maternal and Child Health Hospital from 2026 to 2027. Participants will be randomly assigned in a 1:1 ratio to receive either intranasal Dex (50 μg) or an equal volume of normal saline before the initiation of labor analgesia. Primary Outcome Measure: Incidence of intrapartum fever (temperature ≥ 38.0℃) from initiation of labor analgesia to 2 hours postpartum Secondary Outcome Measures: Temperature-related outcomes: Incidence of fever at thresholds of ≥ 37.5℃ and ≥ 38.5℃; hourly temperature trends assessed by continuous wireless axillary monitoring Analgesic effect: NRS pain scores before labor analgesia and at 30 minutes, 1 hour, and 3 hours after analgesia Sedative effect: Ramsay Sedation Scale scores at the same time points Maternal safety: Incidence of bradycardia (heart rate \< 60 bpm), hypotension (systolic blood pressure \< 90 mmHg or \< 20% of baseline), nausea, vomiting, oversedation (Ramsay ≥ 4), and respiratory depression (SpO₂ \< 90%) Labor characteristics: Duration of first, second, and third stages of labor, total labor duration, and duration of labor analgesia Delivery outcomes: Mode of delivery (spontaneous vaginal delivery or cesarean section) and total consumption of local anesthetics Neonatal outcomes: Apgar scores at 1, 5, and 10 minutes, and NICU admission rate We hypothesize that intranasal Dex administered before labor analgesia will significantly reduce the incidence of intrapartum fever compared to placebo. This study is expected to provide a novel, non-invasive, and effective strategy for preventing epidural-related maternal fever, thereby improving maternal safety and perinatal outcomes in women undergoing vaginal delivery.

Conditions

Intrapartum Fever

Keywords

labor analgesia; Intrapartum Fever; Dexmedetomidine

Outcome Measures

Primary Outcomes (1)

• Incidence of Labor Analgesia-Related Intrapartum Fever (LRIF)

  Proportion of participants with maternal temperature ≥ 38.0°C measured from initiation of labor analgesia to 2 hours postpartum. Temperature is continuously monitored using a wireless axillary sensor.

  Up to 2 hours post-analgesia initiation

Secondary Outcomes (14)

• Incidence of fever at different thresholds

  Up to 2 hours post-analgesia initiation

• Hourly temperature trends

  Hourly, up to 2 hours post-analgesia initiation

• Analgesic effect (NRS pain scores)

  Baseline, 30 minutes, 1 hour, and 3 hours post-analgesia initiation

• Sedative effect (Ramsay Sedation Scale)

  Baseline, 30 minutes, 1 hour, and 3 hours post-analgesia initiation

• Labor characteristics

  Throughout labor and delivery

Study Arms (2)

Intranasal Dexmedetomidine Group

EXPERIMENTAL

Participants in this arm will receive a single dose of intranasal dexmedetomidine 50 μg (one spray of 25 μg per nostril, total two sprays) immediately before initiation of Combined Spinal-Epidural labor analgesia. Labor analgesia follows standard protocol using ropivacaine and sufentanil via patient-controlled epidural analgesia pump.

Drug: Dexmedetomidine

Placebo (Normal Saline) Group

PLACEBO COMPARATOR

Participants in this arm will receive a single dose of intranasal normal saline (one spray per nostril, total two sprays) immediately before initiation of Combined Spinal-Epidural labor analgesia. Labor analgesia follows standard protocol using ropivacaine and sufentanil via patient-controlled epidural analgesia pump.

Drug: Placebo

Interventions

Dexmedetomidine DRUG

A single intranasal dose of dexmedetomidine 50 μg (25 μg per nostril) administered before combined spinal-epidural labor analgesia. Labor analgesia is maintained with ropivacaine and sufentanil via patient-controlled epidural analgesia pump.

Intranasal Dexmedetomidine Group

Placebo DRUG

Intranasal normal saline (one spray per nostril, total two sprays) administered as a single dose before initiation of Combined Spinal-Epidural labor analgesia. Identical in appearance, color, odor, and packaging to the dexmedetomidine nasal spray to maintain blinding.

Placebo (Normal Saline) Group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status II or III
• Age ≥ 18 years
• Singleton pregnancy, cephalic presentation
• No contraindications to neuraxial anesthesia and voluntarily requesting labor analgesia

You may not qualify if:

• Maternal temperature ≥ 37.3°C before labor analgesia
• Allergy to α2-adrenergic receptor agonists
• Severe pregnancy complications or systemic diseases
• Use of analgesics, nonsteroidal anti-inflammatory drugs, or other medications that may affect body temperature within one week prior to enrollment
• Heart rate \< 60 bpm or systolic blood pressure \< 90 mmHg before labor analgesia
• Severe rhinitis or nasal deformity
• Premature rupture of membranes

Sponsors & Collaborators

• Chengdu Jinjiang Maternity and Child Health Hospital: lead

Study Sites (1)

Chengdu Jinjiang District Women & Children Health Hospital

Chengdu, Sichuan, 610011, China

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Bo Liu

CONTACT

+8618502846036; liubojjfy@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, outcome assessors, data managers, and statisticians are blinded to group allocation. The attending anesthesiologist is unblinded but does not participate in any follow-up or outcome assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Anesthesiology Department

Study Record Dates

• First Submitted: March 21, 2026
• First Posted: March 30, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2026-03

Locations

CN (1)