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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| thumbtack needle (TN) group | Active Comparator | 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. |
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| sham TN group | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| thumbtack needle | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline to day 15 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline to day 15 |
| Anxiety status survey: Zung-SAS |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dongmei Huang, Doctor | Contact | 86 13971578190 | 86 27 83663237 | hdmjcr@qq.com |
| Name | Affiliation | Role |
|---|---|---|
| Dongmei Huang, Doctor | Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jingzhou Hospital of Traditional Chinese Medicine | Recruiting | Jingzhou | Hubei | 434300 | China |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 15, 2024 | Jan 5, 2026 | Prot_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2024 | Jan 5, 2026 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009325 | Nausea |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| sham thumbtack needle | Device | 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. |
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Zung-SAS range 25-100, with higher scores means more severe anxiety
| Baseline to day 15 |
| Depression status survey: Zung-SDS | Zung-SDS range 20-80, with higher scores means more severe depression | Baseline to day 15 |
| Sleep status survey: The Pittsburgh sleep quality index (PSQI) | PSQI range 0-21, with higher scores means poorer sleep status | Baseline to day 15 |
| Change of maternal weight from baseline to last visit | Change of maternal weight from baseline to the last visit | Baseline to day 15 |
| Change of electrolyte index (sodium) | Value changes from baseline to the last visit. Unit: mmol/L | Baseline to day 15 |
| Change of electrolyte index (potassium) | Value changes from baseline to the last visit. Unit: mmol/L | Baseline to day 15 |
| Change of electrolyte index (calcium) | Value changes from baseline to the last visit. Unit: mmol/L | Baseline to day 15 |
| Change of electrolyte index (chlorine) | Value changes from baseline to the last visit. Unit: mmol/L | Baseline to day 15 |
| Change of electrolyte index (phosphorus) | Value changes from baseline to the last visit. Unit: mmol/L | Baseline to day 15 |
| Change of electrolyte index (magnesium) | Value changes from baseline to the last visit. Unit: mmol/L | Baseline to day 15 |
| Change of electrolyte index (iron) | Value changes from baseline to the last visit. Unit: μmol/L | Baseline to day 15 |
| Change of electrolyte index (zinc) | Value changes from baseline to the last visit. Unit: μmol/L | Baseline to day 15 |
| Carbon dioxide combining power in the blood | carbon dioxide conbining power in the artery blood. Unit: mmol/L | Baseline to day 15 |
| Change of AST | Value changes from baseline to the last visit. Unit: U/L | Baseline to day 15 |
| Change of ALT | Value changes from baseline to the last visit. Unit: U/L | Baseline to day 15 |
| Change of ALP | Value changes from baseline to the last visit. Unit: U/L | Baseline to day 15 |
| Change of creatinine | Value changes from baseline to the last visit. Unit: μmol/L | Baseline to day 15 |
| Change of urea | Value changes from baseline to the last visit. Unit: mmol/L | Baseline to day 15 |
| Change of TSH | Value changes from baseline to the last visit. Unit: mIU/L | Baseline to day 15 |
| Change of free triiodothyronine | Value changes from baseline to last visit. Unit: pmol/L | Baseline to day 15 |
| Change of free thyroxine | Value changes from baseline to the last visit. Unit: pmol/L | Baseline to day 15 |
| Change of cortisol | Value changes from baseline to the last visit. Unit: ug/dL | Baseline to day 15 |
| Change of ghrelin | Value changes from baseline to the last visit. Unit: ng/ml | Baseline to day 15 |
| Change of leptin | Value changes from baseline to the last visit. Unit: ng/ml | Baseline to day 15 |
| Change of 5-hydroxytryptamine | Value changes from baseline to the last visit. Unit: ng/ml | Baseline to day 15 |
| Change of substance P | Value changes from baseline to the last visit. Unit: pg/ml | Baseline to day 15 |
| Change of arginine vasopressin plasma | Value changes from baseline to the last visit. Unit: pg/ml | Baseline to day 15 |
| Change of GDF 15 | Value changes from baseline to the last visit. Unit: pg/ml | Baseline to day 15 |
| Change of IGFBP 7 | Value changes from baseline to the last visit. Unit: ng/ml | 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. | Baseline to day 15 |
| Number of participants with concomitant treatment | How many participants with concomitant treatment | 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. | 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. | 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. | Data collected from baseline up to 42 days after parturition |
| Number of participants with preterm birth | How many participants with preterm birth | Data collected from baseline to 42 days after postpartum |
| Delivery outcomes | Delivery outcomes including live birth, vaginal birth, caesarean section, gestational age, etc. | Data collected from baseline to 42 days after postpartum |
| Number of participants with neonatal congenital anomalies | Participants with neonatal congenital anomalies | Data collected from baseline to 42 days after postpartum. |
| Number of participants with neonatal mortality | Participants with neonatal mortality | Data collected from baseline to 42 days after postpartum. |
| Number of participants with neonatal hypoglycemia | Participants with neonatal hypoglycemia. | From baseline to 42 days after postpartum. |
| Number of participants with neonatal NICU admission. | Participants with neonatal NICU admission. | 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". | Baseline to day 15 |
| Patient's compliance with treatment | The percentage of the participants which finish the treatment and the follow-up. | Baseline to 42 days after postpartum. |
| Adverse events and serious adverse events | The percentage of adverse events and serious adverse events | Baseline to the end of follow-up (four weeks after the end of treatment) |
| Nanzhang County Traditional Chinese Medicine Hospital | Recruiting | Nanzhang Chengguanzhen | Hubei | 441500 | China |
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| Qianjiang Central Hospital | Recruiting | Qianjiang | Hubei | 433100 | China |
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| Qianjiang Maternal and Child Health Care Hospital | Recruiting | Qianjiang | Hubei | 433199 | China |
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| Shiyan People's Hospital | Recruiting | Shiyan | Hubei | 442099 | China |
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| Suizhou Maternal and Child Health Care Hospital | Recruiting | Suizhou | Hubei | 441399 | China |
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| Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine | Recruiting | Wuhan | Hubei | 430014 | China |
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| Department of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology | Recruiting | Wuhan | Hubei | 430030 | China |
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| Xiangyang Hospital of Traditional Chinese Medicine | Recruiting | Xiangyang | Hubei | 441001 | China |
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| Xiangyang Central Hospital | Recruiting | Xiangyang | Hubei | 441106 | China |
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| Xiaogan Maternal and Child Health Care Hospital | Recruiting | Xiaogan | Hubei | 432001 | China |
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| Dongchangfu District Maternal and Child Health Care Hospital of Liaocheng City | Recruiting | Liaocheng | Shandong | 252004 | China |
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| Aksu Prefecture Maternal and Child Health Hospital | Recruiting | Aksu | Xinjiang | 843099 | China |
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