Clinical Study on a Novel Anti-adhesion Barrier Film (NCT05888545) | Clinical Trial Compass
UnknownNot Applicable
Clinical Study on a Novel Anti-adhesion Barrier Film
China1,176 participantsStarted 2023-04-01
Plain-language summary
The aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions.
Who can participate
Age range18 Years – 40 Years
SexFEMALE
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Inclusion Criteria:
* Voluntarily participate in this trial and sign a written informed consent;
* Women aged 18 ≤ age ≤ 40 years;
* Those who had an abortion in early pregnancy, and those who had a cleanse.
Exclusion Criteria:
* Patients with scars;
* Patients with allergies;
* Patients with acute genitourinary tract infections;
* Patients with abnormalities of reproductive organs and abnormal uterine flexion after cesarean section;
* Patients with decreased menstrual flow after previous curettage;
* Patients with previous suspected or diagnosed uterine adhesions;
* Patients on immunosuppressive drugs;
* Patients with long-term use of antibiotics;
* Patients with malignant tumors of the reproductive organs;
* Patients with uterine adenomyosis, endometriosis, and uterine fibroids;
* Patients with severe systemic diseases;
* Patients with other conditions that are not suitable.
What they're measuring
1
Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.
Timeframe: one week before the third menstrual cycle post-index procedure
Trial details
NCT IDNCT05888545
SponsorThe Fourth Affiliated Hospital of Zhejiang University School of Medicine