Intrapartum FeverNCT07501221
Intranasal Dexmedetomidine for Prevention of Intrapartum Fever
A study testing Dexmedetomidine in people with Intrapartum Fever, run by Chengdu Jinjiang Maternity and Child Health Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Intrapartum Fever
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 446 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA physical status II or III
- Age ≥ 18 years
- Singleton pregnancy, cephalic presentation
- No contraindications to neuraxial anesthesia and voluntarily requesting labor analgesia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Chengdu Jinjiang District Women & Children Health Hospital
Chengdu, Sichuan, 610011
jianjun mao, +8615008460156, jiafeijjfy@163.com
About this study
Official title: Intranasal Dexmedetomidine and Labor Analgesia-Related Intrapartum Fever: A Randomized Controlled Trial
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.
Read more
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.
Read the detailed description
Background: Labor analgesia-related intrapartum fever (LRIF), defined as maternal temperature ≥ 38.0°C following labor analgesia, occurs in 15-25% of parturients and is associated with adverse maternal and neonatal outcomes. Dexmedetomidine (Dex) possesses anti-inflammatory properties, and intranasal administration offers rapid onset, high bioavailability, and non-invasiveness. However, its effect on LRIF has not been evaluated in high-quality prospective studies.
Study Design: This is a prospective, randomized, double-blind, placebo-controlled, single-center trial conducted at Chengdu Jinjiang Maternal and Child Health Hospital (2026-2027).
Intervention: Participants are randomized 1:1 to receive intranasal dexmedetomidine (50 μg, 25 μg per nostril) or intranasal normal saline (equal volume) immediately before labor analgesia. Labor analgesia follows a standardized combined spinal-epidural protocol with patient-controlled epidural analgesia.
Randomization and Blinding: A computer-generated random sequence with block size of 4 is used. Allocation is concealed in sequentially numbered, opaque, sealed envelopes. Double-blinding is implemented: 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.
Data Collection: Temperature is monitored continuously using wireless axillary sensors from analgesia initiation to 2 hours postpartum, ensuring capture of hourly temperature trends and fever events. Pain scores (NRS) and sedation levels (Ramsay Sedation Scale) are assessed at predefined time points: before analgesia, and at 30 min, 1 h, and 3 h after analgesia initiation. Data are extracted from electronic health records and case report forms, with double data entry and source data verification for primary outcome events.
Statistical Analysis: The primary analysis follows the modified intention-to-treat principle. The primary outcome (incidence of LRIF) will be analyzed using chi-square test, with risk ratio and 95% CI reported. Continuous variables will be compared using t-tests or rank-sum tests as appropriate. Logistic regression will be performed to adjust for potential confounders. A two-sided P-value < 0.05 is considered statistically significant.
Ethics: The study has been approved by the Ethics Committee of Chengdu Jinjiang Maternal and Child Health Hospital (Approval No. 202509). Written informed consent will be obtained from all participants.
- Conditions
- Intrapartum Fever
- Being tested
- Dexmedetomidine, Placebo
- Keywords
- labor analgesia, Intrapartum Fever, Dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 2 hours post-analgesia initiation
Secondary outcomes (14)
Incidence of fever at different thresholds
Proportion of participants with maternal temperature ≥ 37.5°C and ≥ 38.5°C during the same period.
Measured: Up to 2 hours post-analgesia initiation
Hourly temperature trends
Maternal temperature recorded every hour from initiation of labor analgesia to 2 hours postpartum.
Measured: Hourly, up to 2 hours post-analgesia initiation
Analgesic effect (NRS pain scores)
Numeric Rating Scale (NRS) pain scores, ranging from 0 (no pain) to 10 (worst possible pain), with higher scores indicating worse pain. Assessed before labor analgesia (T0), and at 30 minutes (T1), 1 hour (T2), and 3 hours (T3) after analgesia.
Measured: Baseline, 30 minutes, 1 hour, and 3 hours post-analgesia initiation
Sedative effect (Ramsay Sedation Scale)
Ramsay Sedation Scale scores, ranging from 1 (anxious, agitated, or restless) to 6 (no response to light glabellar tap or loud auditory stimulus), with higher scores indicating deeper sedation. Assessed at the same time points as pain scores.
Measured: Baseline, 30 minutes, 1 hour, and 3 hours post-analgesia initiation
Labor characteristics
Duration of first, second, and third stages of labor, total labor duration, and duration of labor analgesia.
Measured: Throughout labor and delivery
Mode of delivery
Spontaneous vaginal delivery or cesarean section.
Measured: At delivery
Total consumption of local anesthetics
Total dose (mg) of ropivacaine used during labor analgesia.
Measured: From analgesia initiation to delivery
Incidence of Hypotension
Proportion of participants with systolic blood pressure < 90 mmHg
Measured: Up to 2 hours post-analgesia initiation
Incidence of Bradycardia
Proportion of participants with heart rate < 60 bpm during labor analgesia.
Measured: Up to 2 hours post-analgesia initiation
Incidence of Nausea and Vomiting
Proportion of participants experiencing nausea or vomiting during labor analgesia.
Measured: Up to 2 hours post-analgesia initiation
Incidence of Oversedation
Proportion of participants with Ramsay Sedation Scale score ≥ 4 during labor analgesia.
Measured: Up to 2 hours post-analgesia initiation
Incidence of Respiratory Depression
Proportion of participants with SpO₂ < 90% during labor analgesia.
Measured: Up to 2 hours post-analgesia initiation
Neonatal Apgar Scores
Apgar (Appearance, Pulse, Grimace, Activity, Respiration) scores, ranging from 0 to 10, with higher scores indicating better neonatal condition. Assessed at 1 minute, 5 minutes, and 10 minutes after delivery.
Measured: 1, 5, and 10 minutes post-delivery
NICU Admission Rate
Proportion of neonates admitted to the Neonatal Intensive Care Unit after delivery.
Measured: During neonatal hospitalization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrapartum FeverStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 446 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fei Jia, Chengdu Jinjiang Maternity and Child Health Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07501221
- Sponsor's protocol ID
- 202509
- Status last verified
- Mar 2026
- First submitted
- 21 Mar 2026
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intranasal Dexmedetomidine and Labor Analgesia-Related Intrapartum Fever: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07501221
- Acronym / sponsor ID
- 202509
- Conditions
- Intrapartum Fever
- Keywords
- labor analgesia, Intrapartum Fever, Dexmedetomidine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 446 participants (estimated)
- Lead sponsor
- Chengdu Jinjiang Maternity and Child Health HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background: Labor analgesia-related intrapartum fever (LRIF), defined as maternal temperature ≥ 38.0°C following labor analgesia, occurs in 15-25% of parturients and is associated with adverse maternal and neonatal outcomes. Dexmedetomidine (Dex) possesses anti-inflammatory properties, and intranasal administration offers rapid onset, high bioavailability, and non-invasiveness. However, its effect on LRIF has not been evaluated in high-quality prospective studies.
Study Design: This is a prospective, randomized, double-blind, placebo-controlled, single-center trial conducted at Chengdu Jinjiang Maternal and Child Health Hospital (2026-2027).
Intervention: Participants are randomized 1:1 to receive intranasal dexmedetomidine (50 μg, 25 μg per nostril) or intranasal normal saline (equal volume) immediately before labor analgesia. Labor analgesia follows a standardized combined spinal-epidural protocol with patient-controlled epidural analgesia.
Randomization and Blinding: A computer-generated random sequence with block size of 4 is used. Allocation is concealed in sequentially numbered, opaque, sealed envelopes. Double-blinding is implemented: 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.
Data Collection: Temperature is monitored continuously using wireless axillary sensors from analgesia initiation to 2 hours postpartum, ensuring capture of hourly temperature trends and fever events. Pain scores (NRS) and sedation levels (Ramsay Sedation Scale) are assessed at predefined time points: before analgesia, and at 30 min, 1 h, and 3 h after analgesia initiation. Data are extracted from electronic health records and case report forms, with double data entry and source data verification for primary outcome events.
Statistical Analysis: The primary analysis follows the modified intention-to-treat principle. The primary outcome (incidence of LRIF) will be analyzed using chi-square test, with risk ratio and 95% CI reported. Continuous variables will be compared using t-tests or rank-sum tests as appropriate. Logistic regression will be performed to adjust for potential confounders. A two-sided P-value < 0.05 is considered statistically significant.
Ethics: The study has been approved by the Ethics Committee of Chengdu Jinjiang Maternal and Child Health Hospital (Approval No. 202509). Written informed consent will be obtained from all participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intranasal Dexmedetomidine Group | Experimental | Drug: DexmedetomidineParticipants 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. |
| Placebo (Normal Saline) Group | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- ASA physical status II or III
- Age ≥ 18 years
- Singleton pregnancy, cephalic presentation
- No contraindications to neuraxial anesthesia and voluntarily requesting labor analgesia
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineA 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. | Drug | Intranasal Dexmedetomidine Group |
| PlaceboIntranasal 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. | Drug | Placebo (Normal Saline) Group |
Primary outcome
Incidence of Labor Analgesia-Related Intrapartum Fever (LRIF)
Time frame: Up to 2 hours post-analgesia initiation
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.
14 secondary outcomes
Incidence of fever at different thresholds
Time frame: Up to 2 hours post-analgesia initiation
Hourly temperature trends
Time frame: Hourly, up to 2 hours post-analgesia initiation
Analgesic effect (NRS pain scores)
Time frame: Baseline, 30 minutes, 1 hour, and 3 hours post-analgesia initiation
Sedative effect (Ramsay Sedation Scale)
Time frame: Baseline, 30 minutes, 1 hour, and 3 hours post-analgesia initiation
Labor characteristics
Time frame: Throughout labor and delivery
Mode of delivery
Time frame: At delivery
Total consumption of local anesthetics
Time frame: From analgesia initiation to delivery
Incidence of Hypotension
Time frame: Up to 2 hours post-analgesia initiation
Incidence of Bradycardia
Time frame: Up to 2 hours post-analgesia initiation
Incidence of Nausea and Vomiting
Time frame: Up to 2 hours post-analgesia initiation
Incidence of Oversedation
Time frame: Up to 2 hours post-analgesia initiation
Incidence of Respiratory Depression
Time frame: Up to 2 hours post-analgesia initiation
Neonatal Apgar Scores
Time frame: 1, 5, and 10 minutes post-delivery
NICU Admission Rate
Time frame: During neonatal hospitalization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Intrapartum Fever, run by Chengdu Jinjiang Maternity and Child Health Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bo Liu (+8618502846036, liubojjfy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Labor Analgesia-Related Intrapartum Fever (LRIF) (time frame: Up to 2 hours post-analgesia initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.