Ignite Creation Date:
2024-10-25 @ 7:57 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06566274
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
Thumbtack Needle in the Treatment of NVP
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Clinical Efficacy and Safety Evaluation of Thumbtack Needle in Nausea and Vomiting in Pregnancy a Randomized Controlled Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TTN-NVP
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 TTN on nausea and vomiting in pregnancy NVP
Detailed Description:
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 patients 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 TTN is a method of shallow puncture and long-term retention needle Although the amount of stimulation of TTN 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 TTN the diameter of the needle body is only 015 025mm and the length of the needle body is only 12 25mm 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 TTN 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
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 patients 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 TTN is a method of shallow puncture and long-term retention needle Although the amount of stimulation of TTN 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 TTN the diameter of the needle body is only 015 025mm and the length of the needle body is only 12 25mm 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 TTN 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None