Clinical Efficacy and Safety Evaluation of Thumbtack Needle in Nausea and Vomiting in Pregnancy: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 320
- 试验地点
- 13
- 主要终点
- Score change of pregnancy unique quantification of emesis (PUQE) scale from baseline to day 15.
研究概览
简要总结
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).
详细描述
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 quality of life of pregnant women, and the intensity of influence increases with the frequency of symptoms. Due to the lack of awareness of NVP and the concern about the teratogenicity of drugs to embryos, the treatment of NVP is always insufficient, and the choice of drug regimen is conservative.
Acupuncture using traditional millineedle is effective on NVP, however, it is generally painful when the millineedle is inserted into the body, and the needling sensation of soreness, numbness, swelling and pain during acupuncture is sometimes beyond patient's acceptability, or even produce adverse effects on pregnancy. Moreover, patients may have to visit acupuncturist daily using millineedle, which may causes high financial costs and reduce the medial adherence. Therefore, although acupuncture with millineedle is effective on NVP, its application in clinical practice is still very limited.
As a kind of intradermal needle, thumbtack needle (TN) is a method of shallow puncture and long-term retention needle. Although the amount of stimulation of TN is weaker than that of millineedle, it has a much longer effect and can produce continuous and stable stimulation, and therefore, its cumulative effect is often better than that of traditional millineedle acupuncture. Moreover, due to the tiny needle body of TN (the diameter of the needle body is only 0.15 ~ 0.25mm, and the length of the needle body is only 1.2 ~ 2.5mm), it will not hurt the subcutaneous nerves, blood vessels, viscera and other tissues, which is very comfortable and safe to treat, and overcomes the needle sting pain of traditional millineedles. However, up to now, it is unknown whether TN can produce the same effect as the acupuncture in NVP.
This project is a multi-center, large-sample and blinded RCT designed to collect the highest quality evidence of complete data, including nausea and vomiting, quality of life, anxiety and depression, weight change, blood electrolyte levels, liver and kidney function, thyroid function, intravenous fluid treatment, use of additional drugs, hospital admission, pregnancy complications (gestational diabetes and hypertensive diseases), pregnancy outcomes and neonatal outcomes in women with VNP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Age >20 years, and <45 years.
- •Gestational > 6 weeks, or <12 weeks.
- •PUQE score <
- •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.
研究组 & 干预措施
thumbtack needle (TN) group
The main acupoints of treatment are Zhongwan (CV12), bilateral Neiguan (SP6), and bilateral Zusanli (ST36), with a total of 5 acupoints. patients with Qi stagnation should be added Danzhong (CV17) or Ashi acupoint (the most prominent tender point between CV 17 and CV12), patients with liver and stomach disharmony should be added bilateral BL17, patients with phlegm-dampness obstruction should be added bilateral ST40, and patients with weak spleen and stomach should be added bilateral BL21. The above acupoints are treated with TN. The TN will be reserved in the acupoints for 3 days. During the 3-day retention of TN, the patient presses the TN 3 times a day and half a minute per time per acupoint. After 3 days of retention of TN, the patient is instructed to go to the hospital and receive the next TN treatment. A total of 5 treatments were applied for a duration of 15 days.
干预措施: thumbtack needle (Device)
sham TN group
The acupoints of sham TN group are the same as those of TN group. The use of sham TN was the same as that of the TN group. During the 3-day retention of sham TN, the patients are asked not to press them. After 3 days retention of sham TN, the patient was instructed to go to the hospital, where the doctor removed the sham TN, and conducted the next treatment after local skin disinfection. A total of 5 treatments were given for a duration of 15 days.
干预措施: sham thumbtack needle (Device)
结局指标
主要结局
Score change of pregnancy unique quantification of emesis (PUQE) scale from baseline to day 15.
时间窗: Baseline to day 15
PUQE scores ranged 3 to 15, with higher scores indicating a worse outcome. PUQE scores were evaluated before treatment and on days 3, 6, 9, 12, and 15 of treatment. The primary outcome measure was the change of PUQE score from baseline to day 15.
次要结局
- Anxiety status survey: Zung-SAS(Baseline to day 15)
- Number of participants with neonatal mortality(Data collected from baseline to 42 days after postpartum.)
- The Nausea and Vomiting of Pregnancy Quality of Life (NVPQOL) questionnaire(Baseline to day 15)
- Sleep status survey: The Pittsburgh sleep quality index (PSQI)(Baseline to day 15)
- Change of electrolyte index (phosphorus)(Baseline to day 15)
- Change of AST(Baseline to day 15)
- Change of ALT(Baseline to day 15)
- Change of urea(Baseline to day 15)
- Pregnancy complications(Data collected from baseline up to 42 days after parturition)
- Carbon dioxide combining power in the blood(Baseline to day 15)
- Change of arginine vasopressin plasma(Baseline to day 15)
- Change of GDF 15(Baseline to day 15)
- Change of IGFBP 7(Baseline to day 15)
- Number of participants with concomitant treatment(Baseline to day 15)
- Change of free thyroxine(Baseline to day 15)
- Change of leptin(Baseline to day 15)
- Change of 5-hydroxytryptamine(Baseline to day 15)
- Patient's satisfaction with treatment(Baseline to day 15)
- Adverse events and serious adverse events(Baseline to the end of follow-up (four weeks after the end of treatment))
- Depression status survey: Zung-SDS(Baseline to day 15)
- Change of electrolyte index (sodium)(Baseline to day 15)
- Change of electrolyte index (zinc)(Baseline to day 15)
- Change of maternal weight from baseline to last visit(Baseline to day 15)
- Change of electrolyte index (potassium)(Baseline to day 15)
- Change of electrolyte index (magnesium)(Baseline to day 15)
- Change of electrolyte index (iron)(Baseline to day 15)
- Change of TSH(Baseline to day 15)
- Change of free triiodothyronine(Baseline to day 15)
- Change of cortisol(Baseline to day 15)
- Change of ghrelin(Baseline to day 15)
- Change of electrolyte index (calcium)(Baseline to day 15)
- Change of electrolyte index (chlorine)(Baseline to day 15)
- Change of ALP(Baseline to day 15)
- Change of creatinine(Baseline to day 15)
- Change of substance P(Baseline to day 15)
- Number of participants with intravenous fluid treatment during treatment(Baseline to day 15)
- Number of participants with hospital admission during treatment(Baseline to day 15)
- Number of participants with termination of pregnancy(Data collected from baseline to 1 week after termination of pregnancy)
- Number of participants with preterm birth(Data collected from baseline to 42 days after postpartum)
- Delivery outcomes(Data collected from baseline to 42 days after postpartum)
- Number of participants with neonatal congenital anomalies(Data collected from baseline to 42 days after postpartum.)
- Number of participants with neonatal hypoglycemia(From baseline to 42 days after postpartum.)
- Number of participants with neonatal NICU admission.(From baseline to 42 days after postpartum.)
- Patient's compliance with treatment(Baseline to 42 days after postpartum.)
研究者
Dongmei Huang
associate professor
Huazhong University of Science and Technology