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 range

18 Years – 40 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-01

Contact for this trial

Jian Xu, PhD

18867961080 xuj@zju.edu.cn

View on ClinicalTrials.gov More Intrauterine Adhesion trials