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A prospective, multicenter, randomized controlled clinical trial for the efficacy and safety of uterine stents in the prevention and treatment of intrauterine adhesions

A prospective, multicenter, randomized controlled clinical trial for the efficacy and safety of uterine stents in the prevention and treatment of intrauterine adhesions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023728
Enrollment
Unknown
Registered
2019-06-09
Start date
2017-12-31
Completion date
Unknown
Last updated
2019-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

intrauterine adhesions

Interventions

Experimental group:Put the uterine stent into the uterine cavity after adhesiolysis
Control group:Put the IUD into the uterine cavity after adhesiolysis

Sponsors

The Third Xiangya Hospital of Central South University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: (1) Clinical diagnosis of uterine adhesions with surgical indications (referring to those with fertility requirements or obstructed menstrual blood); (2) Women between the ages of 20 and 40 years; (3) Subjects volunteered to participate in the experiment and signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Abnormal shape of uterine cavity after adhesiolysis; normal uterine cavity can not be clearly separated (bilateral or unilateral oviduct outlet is not visible); genital malformations and uterine cavity too large or too small;Recent uterine perforation; cervical incompetence; (2) Previous treatment of intrauterine adhesions; (3) Endometrial tuberculosis or suspected endometrial tuberculosis; (4) Adenomyosis or the diameter of uterine leiomyoma exceeds 4 cm; (5) Malignancy or suspect malignancy; (6) Acute uterine infection and genital infection; (7) Unknown vaginal bleeding or suspected malignant uterine lesions; (8) Severe anemia and coagulopathy; thrombosis disease; (9) Acute or severe systemic diseases; (10) Severe mental illness and intolerance of surgery; (11) Severe heart, liver and kidney diseases; (12) Anesthesia or surgical contraindications; (13) Participated in other clinical trials within 3 months; (14) Researchers don't think it's appropriate.

Design outcomes

Primary

MeasureTime frame
American fertility society classification 1988;

Secondary

MeasureTime frame
menstrual blood volume;adhesion reformation rate;

Countries

China

Contacts

Public ContactXue Min

The Third Xiangya Hospital of Central South University

xuemin5908@sina.com+86 13687354678

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026