Assessment of usability of tissue hardness tester using acoustic waves

JRCT ID: jRCTs022190005

Registered date:12/07/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: threatened premature labor
• Date of first enrollment: 07/10/2019
• Target sample size: 130
• Study type: Other
• Intervention(s): none

Outcome(s)

• Primary Outcome: Clinical effectiveness of preterm birth risk assessment by hardness tester
• Secondary Outcome: none

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 44age old
• Gender: Female

Include criteria

1) Age: 20 to 44 years old
2) 30 pregnant women of 22 to 36 weeks gestation diagnosed with threatened premature delivery managed in hospital or outpatient in our department
3) 30 pregnant women at 22 to 36 weeks of gestation with no signs of threatened premature delivery managed in outpatient (control group)
4) 70 pregnant women after 37 weeks gestation scheduled for delivery in our department

• Exclude criteria: 1) If not gain consent

Related Information

• Primary Sponsor: Terada Yukihiro
• Source(s) of Monetary Support: Higashiyama Film Co., Ltd.,KAKENHI, Grants-in-Aid for Scientific Research