Status:
RECRUITING
Thumbtack Needle in the Treatment of NVP
Lead Sponsor:
Dongmei Huang
Conditions:
Nausea and Vomiting in Pregnancy (NVP)
Eligibility:
FEMALE
20-45 years
Phase:
NA
Brief Summary
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 p...
Detailed Description
Nausea and vomiting in pregnancy (NVP) is the most common and intractable problem in the first trimester and is the second most common presentation during pregnancy. All types of NVP affect the qualit...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT06566274
Start Date
October 1 2024
End Date
December 31 2028
Last Update
January 8 2026
Active Locations (13)
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1
Jingzhou Hospital of Traditional Chinese Medicine
Jingzhou, Hubei, China, 434300
2
Nanzhang County Traditional Chinese Medicine Hospital
Nanzhang Chengguanzhen, Hubei, China, 441500
3
Qianjiang Central Hospital
Qianjiang, Hubei, China, 433100
4
Qianjiang Maternal and Child Health Care Hospital
Qianjiang, Hubei, China, 433199