An interventional study of thumbtack needle and sham thumbtack needle in Nausea and Vomiting in Pregnancy (NVP), sponsored by Dongmei Huang. Recruiting at 13 sites in China. Open to female participants aged 20 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-01-08.
Sponsored by Dongmei Huang · Not applicable, Interventional, and Treatment
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.
644 studies on the registry are indexed under Nausea; 85 are open to participants now.
This study's planned enrollment of 320 is above the median of 96 across 544 interventional studies indexed under Nausea.
Browse Nausea studies →Dongmei Huang is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: thumbtack needle
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.
Device: sham thumbtack needle
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.
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.
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
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
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)
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Started Oct 2024 (actual). Primary completion is estimated for Oct 2028, 48 months after the start.
Of 120 non-industry interventional studies with no phase under Nausea, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 28. This study's planned 48 months is above that.
Counting every sponsor, half of 126 studies reached it within 13 months; a quarter within 5 and three quarters within 28.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Dongmei Huang