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Clinical efficacy and safety evaluation of thumbtack needle in NVP: a randomized controlled clinical trial

Clinical efficacy and safety evaluation of thumbtack needle in nausea and vomiting in pregnancy: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000231
Enrollment
Unknown
Registered
2024-08-13
Start date
2024-10-08
Completion date
Unknown
Last updated
2024-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

nausea and vomiting of pregnancy

Interventions

TTN group:thumbtack needle
sham TTN group:sham TTN

Sponsors

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1.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 1.single or multiple pregnancy and the weight loss is less than 10% compared with before pregnancy. 2.Women diagnosed with moderate to severe NVP in the first trimester: the severity of NVP was determined by the PUQE score 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. 3.Women voluntarily sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Age 45 years. 2. Gestational age 12 weeks. 3. PUQE score 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). 5. At rest body temperature > 38°C systolic blood pressure 140 mmHg diastolic blood pressure 90 mmHg heart rate = 100 beats per minute or oxygen saturation < 95%. 6. Urinalysis: urine ketones: +++ and above; or (and) urine protein: ++ and above. 7. 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. 8. 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. 9. Suffering from immune diseases such as systemic lupus erythematosus scleroderma dermatomyositis IgG4-related diseases immune nephropathy etc. 10. Have uncorrected diseases of the endocrine system such as diabetes Addison's disease hyperthyroidism hypothyroidism thyroid tumors adrenal tumors etc. 11. Suffering from neurological diseases such as migraine neuromyelitis optica epilepsy neurologic tumors etc. 12. In the past 1 week have taken antiemetic drugs such as ondansetron metoclopramide (metoclopramide) promethazine anti-vomiting Chinese medicine etc. 13. Monoamine oxidase inhibitors are used. 14. Have received TN treatment in recent 3 months. 15. Unwilling to sign the informed consent of this study.

Design outcomes

Primary

MeasureTime frame
the change of PUQE score on day 15 at the end of the treatment when compared with the baseline;

Secondary

MeasureTime frame
Hospital admission during treatment;thyroid function;Pregnancy outcomes;arterial blood gas analysis (carbon dioxide conbining power);kidney function;changes of the weight;changes in electrolytes (sodium, potassium, chloride) in the blood;Adverse events;Pregnancy complications;Treatment compliance of the patients;Patient's satisfaction with treatment;Offspring outcomes;serious adverse events;intravenous fluid therapy;liver function;

Countries

China

Contacts

Public ContactHuang Dongmei

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

hdmjcr@qq.com13971578190

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026