Thumbtack Needle in the Treatment of NVP

Dongmei Huang320 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

320

Conditions

Nausea and Vomiting in Pregnancy (NVP)

Interventions

thumbtack needleDEVICE

As a kind of intradermal needle, thumbtack needle (TN) is a method of shallow puncture and long-term needle.After the TN is attached into the acupoints, it will be reserved in the acupoints for 3 days. After 3 days of retention of TN, the patient is instructed to go to the hospital, where the doctor removes the needle, disinfect the local skin of acupoints and conducts the next TN treatment. A total of 5 treatments were applied for a duration of 15 days.

sham thumbtack needleDEVICE

The sham TN used in the sham TN group has no needle body and its appearance and shape are similar to the real TN. But it does not produce a needle-like effect. The acupoints of sham TN group are the same as those of TN group. The use of sham TN is the same as that of the TN group. After 3 days retention of sham TN, the patient will be instructed to go to the hospital, where the doctor remove the sham TN, and conduct the next treatment after local skin disinfection. A total of 5 treatments will be applied for a duration of 15 days.

Eligibility

Sex: FEMALEMin age: 20 YearsMax age: 45 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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. Exclusion Criteria: * Age \>20 years, and \<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). * 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.

Locations (13)

Jingzhou Hospital of Traditional Chinese Medicine

Jingzhou, Hubei, China

RECRUITING

Nanzhang County Traditional Chinese Medicine Hospital

Nanzhang Chengguanzhen, Hubei, China

Outcomes

Primary Outcomes

Score change of pregnancy unique quantification of emesis (PUQE) scale from 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.

Time frame: Baseline to day 15

Secondary Outcomes

The Nausea and Vomiting of Pregnancy Quality of Life (NVPQOL) questionnaire

The NVPQOL range 30-210, with higher scores means a worse quality of life

Time frame: Baseline to day 15

Anxiety status survey: Zung-SAS

Zung-SAS range 25-100, with higher scores means more severe anxiety

Time frame: Baseline to day 15

Depression status survey: Zung-SDS

Zung-SDS range 20-80, with higher scores means more severe depression

Time frame: Baseline to day 15

Sleep status survey: The Pittsburgh sleep quality index (PSQI)

PSQI range 0-21, with higher scores means poorer sleep status

Time frame: Baseline to day 15

Change of maternal weight from baseline to last visit

Change of maternal weight from baseline to the last visit

Time frame: Baseline to day 15

Change of electrolyte index (sodium)

Value changes from baseline to the last visit. Unit: mmol/L

Time frame: Baseline to day 15

Central Contacts

Dongmei Huang, Doctor

CONTACT

86 13971578190 hdmjcr@qq.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Qianjiang Central Hospital

Qianjiang, Hubei, China

RECRUITING

Qianjiang Maternal and Child Health Care Hospital

Qianjiang, Hubei, China

RECRUITING

Shiyan People's Hospital

Shiyan, Hubei, China

RECRUITING

Suizhou Maternal and Child Health Care Hospital

Suizhou, Hubei, China

RECRUITING

Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine

Wuhan, Hubei, China

RECRUITING

Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

RECRUITING

Xiangyang Hospital of Traditional Chinese Medicine

Xiangyang, Hubei, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, China

RECRUITING

...and 3 more locations

Change of electrolyte index (potassium)

Value changes from baseline to the last visit. Unit: mmol/L

Time frame: Baseline to day 15

Change of electrolyte index (calcium)

Value changes from baseline to the last visit. Unit: mmol/L

Time frame: Baseline to day 15

Change of electrolyte index (chlorine)

Value changes from baseline to the last visit. Unit: mmol/L

Time frame: Baseline to day 15

Change of electrolyte index (phosphorus)

Value changes from baseline to the last visit. Unit: mmol/L

Time frame: Baseline to day 15

Change of electrolyte index (magnesium)

Value changes from baseline to the last visit. Unit: mmol/L

Time frame: Baseline to day 15

Change of electrolyte index (iron)

Value changes from baseline to the last visit. Unit: μmol/L

Time frame: Baseline to day 15

Change of electrolyte index (zinc)

Value changes from baseline to the last visit. Unit: μmol/L

Time frame: Baseline to day 15

Carbon dioxide combining power in the blood

carbon dioxide conbining power in the artery blood. Unit: mmol/L

Time frame: Baseline to day 15

Change of AST

Value changes from baseline to the last visit. Unit: U/L

Time frame: Baseline to day 15

Change of ALT

Value changes from baseline to the last visit. Unit: U/L

Time frame: Baseline to day 15

Change of ALP

Value changes from baseline to the last visit. Unit: U/L

Time frame: Baseline to day 15

Change of creatinine

Value changes from baseline to the last visit. Unit: μmol/L

Time frame: Baseline to day 15

Change of urea

Value changes from baseline to the last visit. Unit: mmol/L

Time frame: Baseline to day 15

Change of TSH

Value changes from baseline to the last visit. Unit: mIU/L

Time frame: Baseline to day 15

Change of free triiodothyronine

Value changes from baseline to last visit. Unit: pmol/L

Time frame: Baseline to day 15

Change of free thyroxine

Value changes from baseline to the last visit. Unit: pmol/L

Time frame: Baseline to day 15

Change of cortisol

Value changes from baseline to the last visit. Unit: ug/dL

Time frame: Baseline to day 15

Change of ghrelin

Value changes from baseline to the last visit. Unit: ng/ml

Time frame: Baseline to day 15

Change of leptin

Value changes from baseline to the last visit. Unit: ng/ml

Time frame: Baseline to day 15

Change of 5-hydroxytryptamine

Value changes from baseline to the last visit. Unit: ng/ml

Time frame: Baseline to day 15

Change of substance P

Value changes from baseline to the last visit. Unit: pg/ml

Time frame: Baseline to day 15

Change of arginine vasopressin plasma

Value changes from baseline to the last visit. Unit: pg/ml

Time frame: Baseline to day 15

Change of GDF 15

Value changes from baseline to the last visit. Unit: pg/ml

Time frame: Baseline to day 15

Change of IGFBP 7

Value changes from baseline to the last visit. Unit: ng/ml

Time frame: Baseline to day 15

Number of participants with intravenous fluid treatment during treatment

If the patient suffers from dehydration or electrolyte imbalances, intravenous fluid treatment will be done.

Time frame: Baseline to day 15

Number of participants with concomitant treatment

How many participants with concomitant treatment

Time frame: Baseline to day 15

Number of participants with hospital admission during treatment

If the patient suffers from further aggravation of neasua and vomiting or hyperemesis gravidarum, hospital admission will be done.

Time frame: Baseline to day 15

Number of participants with 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.

Time frame: Data collected from baseline to 1 week after termination of pregnancy

Pregnancy complications

Pregnancy complications including miscarriage (in the first trimester and in the second trimester), hypertensive disorders, gestational diabetes and so on.

Time frame: Data collected from baseline up to 42 days after parturition

Number of participants with preterm birth

How many participants with preterm birth

Time frame: Data collected from baseline to 42 days after postpartum

Delivery outcomes

Delivery outcomes including live birth, vaginal birth, caesarean section, gestational age, etc.

Time frame: Data collected from baseline to 42 days after postpartum

Number of participants with neonatal congenital anomalies

Participants with neonatal congenital anomalies

Time frame: Data collected from baseline to 42 days after postpartum.

Number of participants with neonatal mortality

Participants with neonatal mortality

Time frame: Data collected from baseline to 42 days after postpartum.

Number of participants with neonatal hypoglycemia

Participants with neonatal hypoglycemia.

Time frame: From baseline to 42 days after postpartum.

Number of participants with neonatal NICU admission.

Participants with neonatal NICU admission.

Time frame: From baseline to 42 days after postpartum.

Patient's satisfaction with treatment

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".

Time frame: Baseline to day 15

Patient's compliance with treatment

The percentage of the participants which finish the treatment and the follow-up.

Time frame: Baseline to 42 days after postpartum.

Adverse events and serious adverse events

The percentage of adverse events and serious adverse events

Time frame: Baseline to the end of follow-up (four weeks after the end of treatment)