Intrahepatic Cholestasis of PregnancyNCT07560722
The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy
A study testing Normal Saline (0.9% NaCl) and Esketamine 0.3mg/kg in people with Intrahepatic Cholestasis of Pregnancy, run by Tianjin Medical University General Hospital at 1 site in China.
Trial summary
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intrahepatic Cholestasis of Pregnancy
- What is being tested?
- Normal Saline (0.9% NaCl) and Esketamine 0.3mg/kg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 5 May 2026to 11 Aug 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 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy.
- Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up.
- Meet the diagnostic criteria of the "Clinical Diagnosis, Treatment and Management Guidelines for Intrahepatic Cholestasis of Pregnancy (2024 Edition)" : fasting serum TBA≥10 μmol/L or postprandial serum TBA≥19 μmol/L.
- Reporting pruritus NRS ≥ 4 points twice within one week.
- Planned to undergo cesarean section under intraspinal anesthesia.
- ASA classification: I - III grade.
Who cannot join
- Those who are known to be allergic to the drug components or have an allergic constitution.
- Related to the safe use of esketamine: history of mental illness; uncontrolled hypertension; uncontrolled hyperthyroidism; increased intracranial pressure, increased intraocular pressure; long-term alcohol consumption or drug abuse history.
- Those with severe organic diseases and liver diseases.
- Those with malignant tumors.
- Other pruritic diseases: uremic pruritus, true erythrocytosis, cutaneous T-cell lymphoma, eosinophilia, drug rash and drug-induced pruritus, and other pruritic diseases that are easily confused, such as atopic dermatitis, pemphigus, scabies, parasitic delusionism, artificial dermatitis, etc.
- Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies.
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- ASA classification as grade IV.
- Those with poor compliance and unable to complete the trial according to the research protocol.
- Those who have participated in other drug clinical trials within the past 4 weeks.
- Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion.
- -
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
Tianjin Medical University General Hospital
Tianjin, 300052
Guolin Wang, +8618604755166, wangguolinghad@hotmail.com
About this study
Official title: The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy:A Single-center Randomized Controlled Trial
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.
Read the detailed description
Intrahepatic cholestasis of pregnancy (ICP) is an important obstetric complication that occurs in the middle and late stages of pregnancy, characterized mainly by pruritus and elevated serum total bile acid (TBA) levels.
Pruritus usually begins on the palms and soles of the feet and can gradually spread. It typically shows a 'lighter during the day and heavier at night' pattern, severely affecting the patient's quality of life. It can also lead to physical and psychological disorders, and even cause mental abnormalities and self-harming behaviors in patients.
Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. It has the effects of rapid pain relief, rapid antidepressant action, sedation, and improvement of sleep. Relevant studies have shown that the NMDA receptor may play an important role in the transmission of non-histaminergic itching. Eslicarbazepine acetate, as a highly selective NMDA receptor antagonist, may alleviate the transmission and propagation of itching. However, there are no reports on whether a single intravenous injection of esketamine can alleviate the pruritus symptoms of patients with pregnancy-induced intrahepatic cholestasis. This experiment aims to investigate the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with pregnancy-induced intrahepatic cholestasis.
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Being tested
- Normal Saline (0.9% NaCl), Esketamine 0.3mg/kg
- Keywords
- esketamine, pruritus
- Medical subject headings
- Intrahepatic Cholestasis of Pregnancy, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal Saline (0.9% NaCl)Drug
The same volume of normal saline was injected after fetal delivery during the operation
Esketamine 0.3mg/kgDrug
Esketamine 0.3mg/kg was given intravenously after fetal delivery during the operation
| Study group | Role | What they receive |
|---|---|---|
| Placebo group of parturients with ICP and pruritus received normal saline | Placebo comparator | The equal volume of normal saline was injected intravenously after fetal delivery during the operation Receives: Drug: Normal Saline (0.9% NaCl) |
| Group of parturients with ICP and pruritus received esketamine 0.3mg/kg | Active comparator | Esketamine 0.3mg/kg was injected intravenously after fetal delivery during the operation Receives: Drug: Esketamine 0.3mg/kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS pruritus score at 24 hours after surgery
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching.
Measured: 24 hours after the surgery
Secondary outcomes (14)
5-D itch scale at 72 hours after surgery
The duration, severity, outcome trend, life impairment, and pruritus site (5-D) were used to evaluate the patient's pruritus. Each dimension was scored from 1 to 5, with a total score ranging from 5 to 25. The higher the score, the more severe the itching.
Measured: 72 hours after surgery
NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching.
Measured: 6 hours、12 hours、48 hours、72 hours and the seventh day after surgery
The incidence of pruritus on the 24 hours after surgery
The NRS pruritus score was completed by the patient 24 hours after the operation. The investigators recorded this score as a statistical indicator.
Measured: 24 hours after surgery
Total bile acid at 24 hours after surgery
The patient's fasting total bile acid level was checked the day before the operation. The investigators rechecked the fasting total bile acid levels 24 hours after the patient's surgery to assess the changes in total bile acid.
Measured: 24 hours after surgery
Pain Score (NRS)
The pain score at rest or after movement was evaluated by pain 11-point numerical rating scale (NRS): 0 = no pain, 10 = greatest imaginable pain.
Measured: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery
The incidence of postoperative sleep disturbance on the first、second and third postoperative nights
The patient completed the Sleep Quality Scale (AIS，Athens Insomnia Scale) one day before the surgery. There are a total of 8 items in the AIS, with the score ranging from 0 to 24. A total score of 6 or above indicates a diagnosis of insomnia. We asked the patients to fill out this questionnaire after the first, second and third postoperative nights to evaluate the changes in sleep quality. The investigators recorded AIS scores as statistical indicators.
Measured: the first、second and third nights after surgery
Postoperative anxiety
The patient completed the Self-Rating Anxiety Scale (SAS, Self-Rating Anxiety Scale) one day before the surgery. The SAS consists of 20 items. Among them, 15 items are positive ratings (such as "I feel more nervous and anxious than usual"), and 5 items are negative ratings (such as "I feel everything is fine", which are the reverse items numbered 5, 9, 13, 17, and 19). The content covers subjective feelings of anxiety and various physical symptoms. The investigators asked the patient to fill out this questionnaire again 72 hours after the surgery to assess the changes in anxiety.
Measured: 72 hours after the surgery
Postoperative depression
The patient completed the Edinburgh Depression Scale (EPDS) one day before the surgery. The EPDS consists of 10 items, covering aspects such as mood, anxiety, and self-blame. Scores range from 0 to 9: within the normal range, no special intervention is required; 10-12: borderline range, suggesting a need for follow-up observation; 13-30: screening positive, indicating possible postpartum depression, and further assessment is necessary. The investigators asked the patient to fill out this questionnaire again at the seventy-second hour after the surgery to assess the changes in depression.
Measured: 72 hours after the surgery
Key time points of the surgery
- Duration of anesthesia （minutes）
- Duration of surgery （minutes）
- The time of fetal delivery（minutes）
Measured: Perioperative period
Intraoperative average blood pressure（mmHg）
Measured: Perioperative period
Intraoperative average heart rate（times per minute）
Measured: Perioperative period
Intraoperative average blood oxygen saturation（%）
Measured: Perioperative period
Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.)
Measured: Perioperative period
Adverse event
All kinds of adverse events( nausea, vomiting, headache，etc) occurred in patients were recorded.
Measured: Within 72 hours after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2026
- Study start5 May 2026 (estimated)
- Primary completion5 May 2027 (estimated)
- Study completion11 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intrahepatic Cholestasis of PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tianjin Medical University General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guolin Wang, Tianjin Medical University General Hospital
- Investigators
- Guolin Wang, Study director, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07560722
- Sponsor's protocol ID
- IRB2026-YX-129-01
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 1 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of a Single Intravenous Injection of Esketamine During Cesarean Section on Postoperative Pruritus in Patients With Intrahepatic Cholestasis of Pregnancy:A Single-center Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07560722
- Acronym / sponsor ID
- IRB2026-YX-129-01
- Conditions
- Intrahepatic Cholestasis of Pregnancy
- Keywords
- esketamine, pruritus
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Tianjin Medical University General HospitalUniversity, hospital or other
- Study start
- 5 May 2026 (estimated)
- Primary completion
- 5 May 2027 (estimated)
- Study completion
- 11 Aug 2027 (estimated)
- First posted
- 1 May 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.
To explore the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with intrahepatic cholestasis of pregnancy.
Detailed description
Intrahepatic cholestasis of pregnancy (ICP) is an important obstetric complication that occurs in the middle and late stages of pregnancy, characterized mainly by pruritus and elevated serum total bile acid (TBA) levels.
Pruritus usually begins on the palms and soles of the feet and can gradually spread. It typically shows a 'lighter during the day and heavier at night' pattern, severely affecting the patient's quality of life. It can also lead to physical and psychological disorders, and even cause mental abnormalities and self-harming behaviors in patients.
Esketamine is the right-handed isomer of ketamine and is a non-competitive N-methyl-D-aspartate (NMDA) receptor antagonist. It has the effects of rapid pain relief, rapid antidepressant action, sedation, and improvement of sleep. Relevant studies have shown that the NMDA receptor may play an important role in the transmission of non-histaminergic itching. Eslicarbazepine acetate, as a highly selective NMDA receptor antagonist, may alleviate the transmission and propagation of itching. However, there are no reports on whether a single intravenous injection of esketamine can alleviate the pruritus symptoms of patients with pregnancy-induced intrahepatic cholestasis. This experiment aims to investigate the effect of a single intravenous injection of esketamine during cesarean section on postoperative pruritus in patients with pregnancy-induced intrahepatic cholestasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo group of parturients with ICP and pruritus received normal saline | Placebo comparator | Drug: Normal Saline (0.9% NaCl)The equal volume of normal saline was injected intravenously after fetal delivery during the operation |
| Group of parturients with ICP and pruritus received esketamine 0.3mg/kg | Active comparator | Drug: Esketamine 0.3mg/kgEsketamine 0.3mg/kg was injected intravenously after fetal delivery during the operation |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy.
- Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up.
- Meet the diagnostic criteria of the "Clinical Diagnosis, Treatment and Management Guidelines for Intrahepatic Cholestasis of Pregnancy (2024 Edition)" : fasting serum TBA≥10 μmol/L or postprandial serum TBA≥19 μmol/L.
- Reporting pruritus NRS ≥ 4 points twice within one week.
- Planned to undergo cesarean section under intraspinal anesthesia.
Key exclusion criteria (11 listed)
- Those who are known to be allergic to the drug components or have an allergic constitution.
- Related to the safe use of esketamine: history of mental illness; uncontrolled hypertension; uncontrolled hyperthyroidism; increased intracranial pressure, increased intraocular pressure; long-term alcohol consumption or drug abuse history.
- Those with severe organic diseases and liver diseases.
- Those with malignant tumors.
- Other pruritic diseases: uremic pruritus, true erythrocytosis, cutaneous T-cell lymphoma, eosinophilia, drug rash and drug-induced pruritus, and other pruritic diseases that are easily confused, such as atopic dermatitis, pemphigus, scabies, parasitic delusionism, artificial dermatitis, etc.
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 |
|---|---|---|
| Normal Saline (0.9% NaCl)The same volume of normal saline was injected after fetal delivery during the operation | Drug | Placebo group of parturients with ICP and pruritus received normal saline |
| Esketamine 0.3mg/kgEsketamine 0.3mg/kg was given intravenously after fetal delivery during the operation | Drug | Group of parturients with ICP and pruritus received esketamine 0.3mg/kg |
Primary outcome
NRS pruritus score at 24 hours after surgery
Time frame: 24 hours after the surgery
The patient evaluated the intensity of pruritus with 11 numbers ranging from 0 to 10, and the higher the number, the more severe the condition. The higher the number, the more severe the itching. 0: No sensation. 1-3: Mild itching. 4-6: Moderate itching. 7-9: Severe itching. 10: Extremely severe itching.
14 secondary outcomes
5-D itch scale at 72 hours after surgery
Time frame: 72 hours after surgery
NRS pruritus score at 6 hours、12 hours、48 hours、72h ours and the seventh day after surgery
Time frame: 6 hours、12 hours、48 hours、72 hours and the seventh day after surgery
The incidence of pruritus on the 24 hours after surgery
Time frame: 24 hours after surgery
Total bile acid at 24 hours after surgery
Time frame: 24 hours after surgery
Pain Score (NRS)
Time frame: 6 hours, 12 hours, 24 hours, 48 hours, 72 hours after the surgery
The incidence of postoperative sleep disturbance on the first、second and third postoperative nights
Time frame: the first、second and third nights after surgery
Postoperative anxiety
Time frame: 72 hours after the surgery
Postoperative depression
Time frame: 72 hours after the surgery
Key time points of the surgery
Time frame: Perioperative period
Intraoperative average blood pressure（mmHg）
Time frame: Perioperative period
Intraoperative average heart rate（times per minute）
Time frame: Perioperative period
Intraoperative average blood oxygen saturation（%）
Time frame: Perioperative period
Intraoperative adverse reactions ( elevated blood pressure, tachycardia, hallucinations, nausea, vomiting, etc.)
Time frame: Perioperative period
Adverse event
Time frame: Within 72 hours after the surgery
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 1 May 2026.
- Individual participant dataSharing planned: No
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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.
Guolin Wang study director
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal Saline (0.9% NaCl) and Esketamine 0.3mg/kg in people with Intrahepatic Cholestasis of Pregnancy, run by Tianjin Medical University General 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 6 inclusion and 11 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 1 May 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 Guolin Wang (+8615822855556, wangguolinghad@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
NRS pruritus score at 24 hours after surgery (time frame: 24 hours after the surgery). 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 1 May 2026.