Thumbtack Needle in the Treatment of NVP

Recruiting now · Not applicable · Has a placebo group

Conditions studied: Nausea and Vomiting in Pregnancy (NVP)

In brief

This project intends to use multi-center, large-sample, randomized, controlled, blinded clinical trials to observe the clinical efficacy and safety of thumbtack needle (TN) on nausea and vomiting in pregnancy (NVP).

Key facts

Study ID

NCT06566274

Run by

Dongmei Huang

People needed

320

Starts

2024-10-01

Expected to finish

2028-12-31

Last updated by the study team

2026-01-08

Who can join

Age: 20 and older, up to 45. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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 is running

• Jingzhou Hospital of Traditional Chinese Medicine — Jingzhou, Hubei, China (enrolling)
• Nanzhang County Traditional Chinese Medicine Hospital — Nanzhang Chengguanzhen, Hubei, China (enrolling)
• Qianjiang Central Hospital — Qianjiang, Hubei, China (enrolling)
• Qianjiang Maternal and Child Health Care Hospital — Qianjiang, Hubei, China (enrolling)
• Shiyan People's Hospital — Shiyan, Hubei, China (enrolling)
• Suizhou Maternal and Child Health Care Hospital — Suizhou, Hubei, China (enrolling)
• Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine — Wuhan, Hubei, China (enrolling)
• Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (enrolling)
• Xiangyang Hospital of Traditional Chinese Medicine — Xiangyang, Hubei, China (enrolling)
• Xiangyang Central Hospital — Xiangyang, Hubei, China (enrolling)
• Xiaogan Maternal and Child Health Care Hospital — Xiaogan, Hubei, China (enrolling)
• Dongchangfu District Maternal and Child Health Care Hospital of Liaocheng City — Liaocheng, Shandong, China (enrolling)
• Aksu Prefecture Maternal and Child Health Hospital — Aksu, Xinjiang, China (enrolling)

Full record on ClinicalTrials.gov

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