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Thumbtack needle treatment for nausea and vomiting in early pregnancy

Clinical Efficacy and Safety Evaluation of Thumbtack Needle in Nausea and Vomiting in Pregnancy: a Randomized Controlled Clinical Trial

Not applicable Interventional Huazhong University of Science and Technology · NCT06566274

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

PhaseNot applicable
Study typeInterventional
Enrollment320 (estimated)
Ages20 Years to 45 Years
SexFemale
SponsorHuazhong University of Science and Technology Academic / other
Locations13 sites (Jingzhou, Hubei and 12 other locations)
Trial IDNCT06566274 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Traditional acupuncture with millineedles has shown effectiveness for NVP, but thumbtack needle is a less-studied intradermal variant and lacks large randomized trial data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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.

Where this trial is running

Jingzhou, Hubei and 12 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Nausea and Vomiting in PregnancyNausea and vomiting in pregnancyThumbtack needle
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.