Thumbtack Needle in the Treatment of NVP

NCT06566274 | Recruiting

• 1 other identifier: TN-NVP
• Study Type: interventional
• Target: 320
• Locations: 1 country
• Sites: 13

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 (TN) on nausea and vomiting in pregnancy (NVP).

Conditions

Nausea and Vomiting in Pregnancy (NVP)

Keywords

Nausea and vomiting in pregnancy; Thumbtack needle

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (44)

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

  Baseline to day 15

• Anxiety status survey: Zung-SAS

  Baseline to day 15

• Depression status survey: Zung-SDS

  Baseline to day 15

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

  Baseline to day 15

• Change of maternal weight from baseline to last visit

  Baseline to day 15

Study Arms (2)

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.

Device: thumbtack needle

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.

Device: sham thumbtack needle

Interventions

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.

thumbtack needle (TN) group

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.

sham TN group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dongmei Huang: lead

Study Sites (13)

Jingzhou Hospital of Traditional Chinese Medicine

Jingzhou, Hubei, 434300, China

RECRUITING

Nanzhang County Traditional Chinese Medicine Hospital

Nanzhang Chengguanzhen, Hubei, 441500, China

RECRUITING

Qianjiang Central Hospital

Qianjiang, Hubei, 433100, China

RECRUITING

Qianjiang Maternal and Child Health Care Hospital

Qianjiang, Hubei, 433199, China

RECRUITING

Shiyan People's Hospital

Shiyan, Hubei, 442099, China

RECRUITING

Suizhou Maternal and Child Health Care Hospital

Suizhou, Hubei, 441399, China

RECRUITING

Wuhan Jinxin Gynecology and Obstetrics Hospital of Integrative Medicine

Wuhan, Hubei, 430014, China

RECRUITING

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

Wuhan, Hubei, 430030, China

RECRUITING

Xiangyang Hospital of Traditional Chinese Medicine

Xiangyang, Hubei, 441001, China

RECRUITING

Xiangyang Central Hospital

Xiangyang, Hubei, 441106, China

RECRUITING

Xiaogan Maternal and Child Health Care Hospital

Xiaogan, Hubei, 432001, China

RECRUITING

Dongchangfu District Maternal and Child Health Care Hospital of Liaocheng City

Liaocheng, Shandong, 252004, China

RECRUITING

Aksu Prefecture Maternal and Child Health Hospital

Aksu, Xinjiang, 843099, China

RECRUITING

MeSH Terms

Conditions

Nausea

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Dongmei Huang, Doctor

  Huazhong University of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongmei Huang, Doctor

CONTACT

86 13971578190; hdmjcr@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 22, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): October 1, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

CN (13)