ITMCTR2024000231尚未招募Unknown
Clinical efficacy and safety evaluation of thumbtack needle in nausea and vomiting in pregnancy: a randomized controlled clinical trial
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology0 个研究点开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 至 45（—）
- 性别
- Female
入选标准
- •3.1.1.1The 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 (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.
- •3.Women voluntarily sign the informed consent form.
排除标准
- •1. Age < 20 years, or > 45 years.
- •2. Gestational age < 6 weeks, or > 12 weeks.
- •3. PUQE score < 6.
- •4. 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).
- •5. Vital signs are unstable, blood pressure drops, and heart rate = 120 beats per minute at rest.
- •6. Urinalysis: urine ketones greater than ++ or (and) protein positive in the urine.
- •7. Blood biochemistry: decreased serum potassium, sodium, and chloride levels; or abnormal liver function: elevated liver enzymes = 2 times the upper limit of normal; or renal dysfunction: elevated serum creatinine and urea nitrogen.
- •8. Arterial blood gas analysis: carbon dioxide binding capacity decreased to < 22 mmol/L.
- •9. Other 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), urinary tract infections (with dysuria or low back pain), viral hepatitis (positive hepatitis virology, liver enzyme levels = 1 000 U/L) or preconception diseases (such as ketoacidosis due to diabetes, Addison disease), acute fatty liver during pregnancy, diseases that can cause vomiting, such as trophoblastic disorders.
- •10. Presence of a psychiatric disorder or psychological disorder.
- •11. In the past 1 week, he has taken antiemetic drugs such as vitamin B6, ondansetron, metoclopramide, prednisone, anti-vomiting Chinese medicine, etc.
- •12. Monoamine oxidase inhibitors are used.
- •13. Have a serious illness or chronic illness.
- •14. Had TTN treatment in recent 3 months.
- •15. Unwilling to sign the informed consent of this study.
研究者
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