Thumbtack needle treatment for nausea and vomiting in early pregnancy
Official title: Clinical Efficacy and Safety Evaluation of Thumbtack Needle in Nausea and Vomiting in Pregnancy: a Randomized Controlled Clinical Trial
Run by Huazhong University of Science and Technology · NCT06566274 · Data updated 2026-11-12
This trial will test whether thumbtack needles can reduce nausea and vomiting in pregnant women during their first trimester with moderate to severe symptoms.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 20 Years to 45 Years |
| Sex | Women only |
| Enrollment | 320 (estimated) |
| Sponsor | Huazhong University of Science and Technology Academic / other |
| Locations | 13 sites (Jingzhou, Hubei and 12 other locations) |
| Status | Recruiting |
| Started | October 1, 2024 |
| Main results expected | October 1, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | January 8, 2026 |
| Trial ID | NCT06566274 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Pregnant women aged 20–45, 6–12 weeks gestation, with a confirmed intrauterine pregnancy, PUQE score ≥6, and less than 10% pre-pregnancy weight loss are ideal candidates.
✕Probably not a fit
Women with mild symptoms (PUQE <6), significant weight loss or dehydration (>10% weight loss or clinical signs of hypovolemia), or who are outside the 6–12 week gestational window are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a multi-center, randomized, blinded, controlled trial comparing thumbtack needle (a shallow intradermal, long-retention needle) to a sham thumbtack needle for pregnant women with PUQE scores ≥6 between 6 and 12 weeks' gestation. Participants will receive the assigned intervention at specified acupoints and be followed for changes in PUQE score, safety, tolerability, and quality-of-life measures. The thumbtack needle is intended to deliver continuous low-level stimulation with fewer clinic visits than traditional millineedle acupuncture. The trial enrolls a large sample across three hospitals in Hubei, China with predefined inclusion and exclusion criteria and routine adverse-event monitoring.
Why it matters
Potential benefit: If successful, the intervention could reduce nausea and vomiting severity and improve quality of life while offering a low-cost, low-drug option for early pregnancy.
How similar studies have gone: Traditional acupuncture with millineedles has shown effectiveness for NVP, but thumbtack needle is a less-studied intradermal variant and lacks large randomized trial data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * The mother\'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.
Where it's running
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Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, China Recruiting -
Nanzhang County Traditional Chinese Medicine Hospital
Nanzhang Chengguanzhen, Hubei, China Recruiting -
Qianjiang Central Hospital
Qianjiang, Hubei, China Recruiting -
Qianjiang Maternal and Child Health Care Hospital
Qianjiang, Hubei, China Recruiting -
Shiyan People's Hospital
Shiyan, Hubei, China Recruiting -
Suizhou Maternal and Child Health Care Hospital
Suizhou, Hubei, China Recruiting
Show 7 more locations
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Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine
Wuhan, Hubei, China Recruiting -
Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China Recruiting -
Xiangyang Hospital of Traditional Chinese Medicine
Xiangyang, Hubei, China Recruiting -
Xiangyang Central Hospital
Xiangyang, Hubei, China Recruiting -
Xiaogan Maternal and Child Health Care Hospital
Xiaogan, Hubei, China Recruiting -
Dongchangfu District Maternal and Child Health Care Hospital of Liaocheng City
Liaocheng, Shandong, China Recruiting -
Aksu Prefecture Maternal and Child Health Hospital
Aksu, Xinjiang, China Recruiting
Study contacts
- Principal investigator: Dongmei Huang, Doctor — Huazhong University of Science and Technology
- Study coordinator: Dongmei Huang, Doctor
- Email: hdmjcr@qq.com
- Phone: 86 13971578190
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.