Intranasal Dexmedetomidine for Prevention of Intrapartum Fever

Starting soon · Not applicable · Has a placebo group

Conditions studied: Intrapartum Fever

In brief

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.

Key facts

Study ID: NCT07501221
Run by: Chengdu Jinjiang Maternity and Child Health Hospital
People needed: 446
Starts: 2026-05-01
Expected to finish: 2027-10-01
Last updated by the study team: 2026-03-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

Chengdu Jinjiang District Women & Children Health Hospital — Chengdu, Sichuan, China

Full record on ClinicalTrials.gov

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