Clinical efficacy and safety evaluation of thumbtack needle in NVP: a randomized controlled clinical trial

Recruitment & Eligibility

Status: Pending

Sex: Female

Target Recruitment: Not specified

Inclusion Criteria

3.1.1.1The mother's age is 20 ~ 45 years old, the gestational age is 6 ~ 12 weeks, and the ultrasound confirms that it is an intrauterine 1.single or multiple pregnancy, and the weight loss is less than 10% compared with before pregnancy.
2.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.
3.Women voluntarily sign the informed consent form.

Exclusion Criteria

1. Age < 20 years, or > 45 years.
2. Gestational age < 6 weeks, or > 12 weeks.
3. PUQE score < 6.
4. 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).
5. Vital signs are unstable, blood pressure drops, and heart rate = 120 beats per minute at rest.
6. Urinalysis: urine ketones greater than ++ or (and) protein positive in the urine.
7. Blood biochemistry: decreased serum potassium, sodium, and chloride levels; or abnormal liver function: elevated liver enzymes = 2 times the upper limit of normal; or renal dysfunction: elevated serum creatinine and urea nitrogen.
8. Arterial blood gas analysis: carbon dioxide binding capacity decreased to < 22 mmol/L.
9. Other 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), urinary tract infections (with dysuria or low back pain), viral hepatitis (positive hepatitis virology, liver enzyme levels = 1 000 U/L) or preconception diseases (such as ketoacidosis due to diabetes, Addison disease), acute fatty liver during pregnancy, diseases that can cause vomiting, such as trophoblastic disorders.
10. Presence of a psychiatric disorder or psychological disorder.
11. In the past 1 week, he has taken antiemetic drugs such as vitamin B6, ondansetron, metoclopramide, prednisone, anti-vomiting Chinese medicine, etc.
12. Monoamine oxidase inhibitors are used.
13. Have a serious illness or chronic illness.
14. Had TTN treatment in recent 3 months.
15. Unwilling to sign the informed consent of this study.

Study & Design

Study Type: Interventional study

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
the change of PUQE score on day 15 at the end of the treatment when compared with the baseline;

Secondary Outcome Measures

Name	Time	Method
Hospital admission during treatment;blood IGFBP 7;blood 5-hydroxytryptamine;thyroid function;Pregnancy outcomes;arterial blood gas analysis (carbon dioxide conbining power);blood substance P;kidney function;changes of the weight;blood cortisol;blood leptin;blood arginine vasopressin;changes in electrolytes (sodium, potassium, chloride) in the blood;Adverse events;Pregnancy complications;blood GDF15;Treatment compliance of the patients;blood ghrelin;Patient's satisfaction with treatment;Offspring outcomes;serious adverse events;intravenous fluid therapy;liver function;