Thumbtack Needle in the Treatment of NVP
NCT Number: NCT06566274
Acronym: TTN-NVP
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Nausea and Vomiting in Pregnancy (NVP)
Interventions: DEVICE: thumbtack needle|DEVICE: sham thumbtack needle|OTHER: black control
Sponsor: Dongmei Huang
Sex: FEMALE
Age: ADULT
Enrollment: 483
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-20
Completion Date: 2028-12-31

Summary:
This project intends to use multi-center, large-sample, randomized, controlled, double-blind clinical trials to observe the clinical efficacy and safety of thumbtack needle (TTN) on nausea and vomiting in pregnancy (NVP).

Primary Outcome Measures: 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 Outcome Measures: 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, 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)