Clinical trial NCT06566274: Thumbtack Needle in the Treatment of NVP
Official title: Clinical Efficacy and Safety Evaluation of Thumbtack Needle in Nausea and Vomiting in Pregnancy: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Nausea and Vomiting in Pregnancy (NVP)
Keywords: Nausea and vomiting in pregnancy
Thumbtack needle
Lead sponsor: Huazhong University of Science and Technology
Sponsor class: OTHER
First posted: 2024-08-22
Enrollment: 320
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 (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 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.

Eligibility criteria: Inclusion Criteria:

* The mother\&#39;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, \&lt; 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 Criteria:

* Age \&lt; 20 years, or \&gt; 45 years.
* Gestational \&lt; 6 weeks, or \&gt; 12 weeks.
* PUQE score \&lt; 6.
* frequent nausea and vomiting, weight loss of \&gt;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 \&gt; 38°C, systolic blood pressure \&lt; 90 mmHg or \&gt; 140 mmHg, diastolic blood pressure \&lt; 60 mmHg or \&gt;90 mmHg, heart rate ≥ 100 beats per minute, or oxygen saturation \&lt; 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\&#39;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 TTN treatment in recent 3 months.
* Unwilling to sign the informed consent of this study.

Primary outcomes:
measure: Score change of pregnancy unique quantification of emesis (PUQE) scale from baseline to day 15.
timeFrame: Baseline to day 15
Secondary outcomes:
measure: The Nausea and Vomiting of Pregnancy Quality of Life (NVPQOL) questionnaire
timeFrame: Baseline to day 15
measure: Anxiety status survey: Zung-SAS
timeFrame: Baseline to day 15
measure: Depression status survey: Zung-SDS
timeFrame: Baseline to day 15
measure: Sleep status survey: The Pittsburgh sleep quality index (PSQI)
timeFrame: Baseline to day 15
measure: Change of maternal weight from baseline to last visit
timeFrame: Baseline to day 15
measure: Change of electrolyte index (sodium)
timeFrame: Baseline to day 15
measure: Change of electrolyte index (potassium)
timeFrame: Baseline to day 15
measure: Change of electrolyte index (calcium)
timeFrame: Baseline to day 15
measure: Change of electrolyte index (chlorine)
timeFrame: Baseline to day 15
measure: Change of electrolyte index (phosphorus)
timeFrame: Baseline to day 15
measure: Change of electrolyte index (magnesium)
timeFrame: Baseline to day 15
measure: Change of electrolyte index (iron)
timeFrame: Baseline to day 15
measure: Change of electrolyte index (zinc)
timeFrame: Baseline to day 15
measure: Carbon dioxide combining power in the blood
timeFrame: Baseline to day 15
measure: Change of AST
timeFrame: Baseline to day 15
measure: Change of ALT
timeFrame: Baseline to day 15
measure: Change of ALP
timeFrame: Baseline to day 15
measure: Change of creatinine
timeFrame: Baseline to day 15
measure: Change of urea
timeFrame: Baseline to day 15
measure: Change of TSH
timeFrame: Baseline to day 15
measure: Change of free triiodothyronine
timeFrame: Baseline to day 15
measure: Change of free thyroxine
timeFrame: Baseline to day 15
measure: Change of cortisol
timeFrame: Baseline to day 15
measure: Change of ghrelin
timeFrame: Baseline to day 15
measure: Change of leptin
timeFrame: Baseline to day 15
measure: Change of 5-hydroxytryptamine
timeFrame: Baseline to day 15
measure: Change of substance P
timeFrame: Baseline to day 15
measure: Change of arginine vasopressin plasma
timeFrame: Baseline to day 15
measure: Change of GDF 15
timeFrame: Baseline to day 15
measure: Change of IGFBP 7
timeFrame: Baseline to day 15
measure: Number of participants with intravenous fluid treatment during treatment
timeFrame: Baseline to day 15
measure: Number of participants with concomitant treatment
timeFrame: Baseline to day 15
measure: Number of participants with hospital admission during treatment
timeFrame: Baseline to day 15
measure: Number of participants with termination of pregnancy
timeFrame: Data collected from baseline to 1 week after termination of pregnancy
measure: Pregnancy complications
timeFrame: Data collected from baseline up to 42 days after parturition
measure: Number of participants with preterm birth
timeFrame: Data collected from baseline to 42 days after postpartum
measure: Delivery outcomes
timeFrame: Data collected from baseline to 42 days after postpartum
measure: Number of participants with neonatal congenital anomalies
timeFrame: Data collected from baseline to 42 days after postpartum.
measure: Number of participants with neonatal mortality
timeFrame: Data collected from baseline to 42 days after postpartum.
measure: Number of participants with neonatal hypoglycemia
timeFrame: From baseline to 42 days after postpartum.
measure: Number of participants with neonatal NICU admission.
timeFrame: From baseline to 42 days after postpartum.
measure: Patient's satisfaction with treatment
timeFrame: Baseline to day 15
measure: Patient's compliance with treatment
timeFrame: Baseline to 42 days after postpartum.
measure: Adverse events and serious adverse events
timeFrame: Baseline to the end of follow-up (four weeks after the end of treatment)
Other outcomes:
Locations:
Study officials:
affiliation: Huazhong University of Science and Technology
name: Dongmei Huang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: