One shot during c-section may stop unbearable itching for moms with liver condition
NCT ID NCT07560722
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether giving a single intravenous dose of esketamine during a C-section can reduce the intense itching that often follows surgery in women with intrahepatic cholestasis of pregnancy. 160 women will be randomly assigned to receive either esketamine or a placebo (saline) right after delivery. The main goal is to see if itching scores drop within 24 hours, with follow-up at 72 hours.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Esketamine (a fast-acting anesthetic drug given by IV)
- What this could lead to
- If it works, this could offer a new way to ease severe itching after C-section for women with this liver condition, improving comfort without strong side effects.
- What could go wrong
- This is a small, early-stage trial with only 160 participants, so results may not apply to everyone. Esketamine can cause dizziness, nausea, or temporary dissociation, and the benefit over placebo is uncertain.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 40 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age: 18 - 40 years old; Gestational age: ≥ 35 weeks; Singleton pregnancy. 2. Clear consciousness, able to cooperate with NRS scoring, laboratory tests and follow-up. 3. 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. 4. Reporting pruritus NRS ≥ 4 points twice within one week. 5. Planned to undergo cesarean section under intraspinal anesthesia. 6. ASA classification: I - III grade. Exclusion Criteria: 1. Those who are known to be allergic to the drug components or have an allergic constitution. 2. 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. 3. Those with severe organic diseases and liver diseases. 4. Those with malignant tumors. 5. 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. 6. Eclampsia and pre-eclampsia, HELLP syndrome; fetal developmental abnormalities, multiple pregnancies. 7. ASA classification as grade IV. 8. Those with poor compliance and unable to complete the trial according to the research protocol. 9. Those who have participated in other drug clinical trials within the past 4 weeks. 10. Due to any reason, the researchers consider that there is any situation that is not suitable for inclusion. \-
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tianjin Medical University General Hospital
Tianjin, 300052, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can an experimental drug ease a pregnancy liver condition?
- New study seeks clues to mysterious pregnancy itching disorder
- Could bile acid fingerprints prevent stillbirths in pregnancy cholestasis?
- Could bile acids cause baby lung issues? new study investigates
- New hope for Moms-to-Be: drug targets dangerous pregnancy itch