Acupuncture-style thumbtack needles may ease severe morning sickness

NCT ID NCT06566274

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Expanded access (not trials)

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First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether tiny thumbtack needles placed on the skin can safely reduce nausea and vomiting in pregnant women. About 320 women with moderate to severe symptoms in early pregnancy will receive the treatment. Researchers will measure symptom changes and quality of life over 15 days.

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Study facts

What this study's own registry entry says, in plain language.

Phase

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

About 320 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2028

An estimate. End dates often move.

Lead sponsor

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

20 to 45 years

Sex

Female participants only

Healthy volunteers

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

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * The mother\&#39;s age is 20 \~ 45 years old, the gestational age is 6 \~ 12 weeks, and the ultrasound confirms that it is an intrauterine single or multiple pregnancy, and the weight loss is less than 10% compared with before pregnancy. * Women diagnosed with moderate to severe NVP in the first trimester: the severity of NVP was determined by the PUQE score (see Table 1), and the PUQE score ranged from 3 \~ 15, \< 6 was mild NVP, 6 \~ 12 was moderate NVP, and ≥13 was severe NVP. PUQE score ≥ 6 may be included in this study. * Women voluntarily sign the informed consent form. Exclusion Criteria: * Age \>20 years, and \<45 years. * Gestational \> 6 weeks, or \<12 weeks. * PUQE score \<6. * frequent nausea and vomiting, weight loss of \>10% compared with before pregnancy; or symptoms such as listlessness, paleness, dry skin, sunken eye sockets, and a marked decrease in urine output (less than 400ml of urine in 24 hours or less than 5 times and a small amount of urine in 24 hours). * At rest, body temperature \> 38°C, systolic blood pressure \< 90 mmHg or \> 140 mmHg, diastolic blood pressure \< 60 mmHg or \> 90 mmHg, heart rate ≥ 100 beats per minute, or oxygen saturation \< 95%. * Urinalysis: urine ketones: +++ and above; or (and) urine protein: ++ and above. * Blood biochemistry: serum potassium≤3.0mmol/L, serum sodium≤130mmol/L; or abnormal liver function: elevated liver enzymes ≥ 2 times the upper limit of normal; or renal dysfunction: elevated serum creatinine and urea nitrogen. * Other digestive diseases that cause nausea and vomiting, such as gastrointestinal infections (with diarrhea), gastric ulcers (with epigastric pain or hematemesis), cholecystitis, biliary roundworms, pancreatitis (with abdominal pain, plasma amylase levels rise to 5 \~ 10 times normal), viral hepatitis (positive hepatitis virology, liver enzyme levels ≥ 1 000 U/L) or acute fatty liver during pregnancy, tumors of the digestive tract. * Suffering from immune diseases such as systemic lupus erythematosus, scleroderma, dermatomyositis, IgG4-related diseases, immune nephropathy, etc. * Have uncorrected diseases of the endocrine system, such as diabetes, Addison's disease, hyperthyroidism, hypothyroidism, thyroid tumors, adrenal tumors, etc. * Suffering from neurological diseases such as migraine, neuromyelitis optica, epilepsy, neurologic tumors, etc. * In the past 1 week, have taken antiemetic drugs such as ondansetron, metoclopramide (metoclopramide), promethazine, anti-vomiting Chinese medicine, etc. * Monoamine oxidase inhibitors are used. * Have received TN treatment in recent 3 months. * Unwilling to sign the informed consent of this study.

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Conditions

The condition(s) this trial relates to.

Nausea

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.

  1. The places running it

    13 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Aksu Prefecture Maternal and Child Health Hospital

    RECRUITING

    Aksu, Xinjiang, 843099, China

  • Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

    RECRUITING

    Wuhan, Hubei, 430030, China

  • Dongchangfu District Maternal and Child Health Care Hospital of Liaocheng City

    RECRUITING

    Liaocheng, Shandong, 252004, China

  • Jingzhou Hospital of Traditional Chinese Medicine

    RECRUITING

    Jingzhou, Hubei, 434300, China

  • Nanzhang County Traditional Chinese Medicine Hospital

    RECRUITING

    Nanzhang Chengguanzhen, Hubei, 441500, China

  • Qianjiang Central Hospital

    RECRUITING

    Qianjiang, Hubei, 433100, China

  • Qianjiang Maternal and Child Health Care Hospital

    RECRUITING

    Qianjiang, Hubei, 433199, China

  • Shiyan People's Hospital

    RECRUITING

    Shiyan, Hubei, 442099, China

  • Suizhou Maternal and Child Health Care Hospital

    RECRUITING

    Suizhou, Hubei, 441399, China

  • Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine

    RECRUITING

    Wuhan, Hubei, 430014, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, 441106, China

  • Xiangyang Hospital of Traditional Chinese Medicine

    RECRUITING

    Xiangyang, Hubei, 441001, China

  • Xiaogan Maternal and Child Health Care Hospital

    RECRUITING

    Xiaogan, Hubei, 432001, China

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