Thumbtack Needle in the Treatment of NVP
- Conditions
- Nausea and Vomiting in Pregnancy (NVP)
- Interventions
- Device: sham thumbtack needleDevice: thumbtack needle
- Registration Number
- NCT06566274
- Lead Sponsor
- Dongmei Huang
- Brief Summary
This project intends to use multi-center, large-sample, randomized, controlled, double-blind clinical trials to observe the clinical efficacy and safety of thumbtack needle (TTN) on nausea and vomiting in pregnancy (NVP).
- 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 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 (TTN) is a method of shallow puncture and long-term retention needle. Although the amount of stimulation of TTN 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 TTN (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 TTN can produce the same effect as the acupuncture in NVP.
This project is a multi-center, large-sample and double 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- Female
- Target Recruitment
- 483
- 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.
- Age < 20 years, or > 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).
- Vital signs are unstable, blood pressure drops, and heart rate ≥ 120 beats per minute at rest.
- Urinalysis: urine ketones greater than ++ or (and) protein positive in the urine.
- 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.
- Arterial blood gas analysis: carbon dioxide binding capacity decreased to < 22 mmol/L.
- 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.
- Presence of a psychiatric disorder or psychological disorder.
- In the past 1 week, he has taken antiemetic drugs such as vitamin B6, ondansetron, metoclopramide, prednisone, anti-vomiting Chinese medicine, etc.
- Monoamine oxidase inhibitors are used.
- Have a serious illness or chronic illness.
- Had TTN treatment in recent 3 months.
- Unwilling to sign the informed consent of this study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham TTN group sham thumbtack needle The acupoints of sham TTN group are the same as those of TTN group. The use of sham TTN was the same as that of the TTN group. After 3 days retention of sham NNT, the patient was instructed to go to the hospital, where the doctor removed the sham TTN, and conducted the next treatment after local skin disinfection. A total of 5 treatments were given for a duration of 15 days. thumbtack needle (TTN) group thumbtack needle The main acupoints of treatment are CV1, SP, and bilateral ST36, with a total of 5 acupoints. 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 TTN. The TTN will be reserved in the acupoints for 3 days. After 3 days of retention of TTN, the patient is instructed to go to the hospital and receive the next TTN treatment. A total of 5 treatments were applied for a duration of 15 days.
- Primary Outcome Measures
Name Time Method Score change of pregnancy unique quantification of emesis (PUQE) scale from baseline to day 15. 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.
- Secondary Outcome Measures
Name Time Method Anxiety status survey: Zung-SAS Baseline to day 15 Zung-SAS range 25-100, with higher scores means more severe anxiety
Depression status survey: Zung-SDS Baseline to day 15 Zung-SDS range 20-80, with higher scores means more severe depression
Change of electrolyte index (sodium) Baseline to day 15 Value changes from baseline to the last visit. Unit: mmol/L
Change of electrolyte index (zinc) Baseline to day 15 Value changes from baseline to the last visit. Unit: μmol/L
The Nausea and Vomiting of Pregnancy Quality of Life (NVPQOL) questionnaire Baseline to day 15 The NVPQOL range 30-210, with higher scores means a worse quality of life
Sleep status survey: The Pittsburgh sleep quality index (PSQI) Baseline to day 15 PSQI range 0-21, with higher scores means poorer sleep status
Change of electrolyte index (phosphorus) Baseline to day 15 Value changes from baseline to the last visit. Unit: mmol/L
Change of AST Baseline to day 15 Value changes from baseline to the last visit. Unit: U/L
Change of ALT Baseline to day 15 Value changes from baseline to the last visit. Unit: U/L
Change of urea Baseline to day 15 Value changes from baseline to the last visit. Unit: mmol/L
Change of maternal weight from baseline to last visit Baseline to day 15 Change of maternal weight from baseline to the last visit
Change of electrolyte index (potassium) Baseline to day 15 Value changes from baseline to the last visit. Unit: mmol/L
Change of electrolyte index (magnesium) Baseline to day 15 Value changes from baseline to the last visit. Unit: mmol/L
Change of electrolyte index (iron) Baseline to day 15 Value changes from baseline to the last visit. Unit: μmol/L
Change of TSH Baseline to day 15 Value changes from baseline to the last visit. Unit: mIU/L
Change of free triiodothyronine Baseline to day 15 Value changes from baseline to last visit. Unit: pmol/L
Change of cortisol Baseline to day 15 Value changes from baseline to the last visit. Unit: ug/dL
Change of ghrelin Baseline to day 15 Value changes from baseline to the last visit. Unit: ng/ml
Pregnancy complications Data collected from baseline up to 42 days after parturition Pregnancy complications including miscarriage (in the first trimester and in the second trimester), hypertensive disorders, gestational diabetes and so on.
Change of electrolyte index (calcium) Baseline to day 15 Value changes from baseline to the last visit. Unit: mmol/L
Change of electrolyte index (chlorine) Baseline to day 15 Value changes from baseline to the last visit. Unit: mmol/L
Carbon dioxide combining power in the blood Baseline to day 15 carbon dioxide conbining power in the artery blood. Unit: mmol/L
Change of ALP Baseline to day 15 Value changes from baseline to the last visit. Unit: U/L
Change of creatinine Baseline to day 15 Value changes from baseline to the last visit. Unit: μmol/L
Change of arginine vasopressin plasma Baseline to day 15 Value changes from baseline to the last visit. Unit: pg/ml
Change of GDF 15 Baseline to day 15 Value changes from baseline to the last visit. Unit: pg/ml
Change of IGFBP 7 Baseline to day 15 Value changes from baseline to the last visit. Unit: ng/ml
Number of participants with concomitant treatment Baseline to day 15 How many participants with concomitant treatment
Change of free thyroxine Baseline to day 15 Value changes from baseline to the last visit. Unit: pmol/L
Change of leptin Baseline to day 15 Value changes from baseline to the last visit. Unit: ng/ml
Change of 5-hydroxytryptamine Baseline to day 15 Value changes from baseline to the last visit. Unit: ng/ml
Change of substance P Baseline to day 15 Value changes from baseline to the last visit. Unit: pg/ml
Number of participants with intravenous fluid treatment during treatment Baseline to day 15 If the patient suffers from dehydration or electrolyte imbalances, intravenous fluid treatment will be done.
Number of participants with hospital admission during treatment Baseline to day 15 If the patient suffers from further aggravation of neasua and vomiting or hyperemesis gravidarum, hospital admission will be done.
Number of participants with termination of pregnancy Data collected from baseline to 1 week after termination of pregnancy If the patient suffers from further aggravation of hyperemesis gravidarum, the termination of a wanted pregnancy will be done due to life in danger. Or if congenital anomalies are found by ultrasound, the termination of a wanted pregnancy will be done.
Number of participants with preterm birth Data collected from baseline to 42 days after postpartum How many participants with preterm birth
Delivery outcomes Data collected from baseline to 42 days after postpartum Delivery outcomes including live birth, vaginal birth, caesarean section, gestational age, etc.
Number of participants with neonatal congenital anomalies Data collected from baseline to 42 days after postpartum. Participants with neonatal congenital anomalies
Number of participants with neonatal mortality Data collected from baseline to 42 days after postpartum. Participants with neonatal mortality
Number of participants with neonatal hypoglycemia From baseline to 42 days after postpartum. Participants with neonatal hypoglycemia.
Number of participants with neonatal NICU admission. From baseline to 42 days after postpartum. Participants with neonatal NICU admission.
Patient's satisfaction with treatment Baseline to day 15 Questionnaire such as loss of confidence, doubt of the efficacy or intolerance to the treatment of TTN and so on. The answer is "yes" or "no".
Adverse events and serious adverse events Baseline to the end of follow-up (four weeks after the end of treatment) The percentage of adverse events and serious adverse events
Patient's compliance with treatment Baseline to 42 days after postpartum. The percentage of the participants which finish the treatment and the follow-up.