Testing a new film to prevent intrauterine adhesions after abortion

A Randomized Controlled Study on an Anti-adhesion Diaphragm in Preventing Intrauterine Adhesions

This study is testing a new device to see if it can help prevent scar tissue from forming in the uterus after an early pregnancy abortion.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 1176 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine (Academic / other)
• Locations: 8 sites (Hangzhou, Zhejiang and 7 other locations)
• Trial ID: NCT05888545 on ClinicalTrials.gov

What this trial studies

This clinical study aims to evaluate the effectiveness and safety of a novel anti-adhesion diaphragm designed to prevent intrauterine adhesions following early pregnancy abortion. Participants will be randomly assigned to either receive the anti-adhesion diaphragm for 3-7 days post-abortion or conventional treatment without additional interventions. The study will compare the outcomes of both groups to determine the efficacy of the diaphragm in clinical practice.

Who should consider this trial

Good fit: Ideal candidates for this study are women aged 18 to 40 who have undergone an early pregnancy abortion.

Not a fit: Patients with existing uterine conditions or those on immunosuppressive therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of intrauterine adhesions, improving reproductive health outcomes for women.

How similar studies have performed: While the approach of using an anti-adhesion barrier film is innovative, similar studies have shown promise in reducing adhesions in other surgical contexts.

Eligibility criteria

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.

Where this trial is running

Hangzhou, Zhejiang and 7 other locations

• The Affiliated Hospital of Hangzhou Normal University — Hangzhou, Zhejiang, China (Not_yet_recruiting)
• Lishui Hospital of TCM — Lishui, Zhejiang, China (Not_yet_recruiting)
• Lishui People's Hospital — Lishui, Zhejiang, China (Not_yet_recruiting)
• Quzhou People's Hospital — Quzhou, Zhejiang, China (Not_yet_recruiting)
• The Second People's Hospital Of Quzhou, Zhejiang — Quzhou, Zhejiang, China (Not_yet_recruiting)
• Wenzhou Central Hospital — Wenzhou, Zhejiang, China (Not_yet_recruiting)
• The Fourth Affiliated Hospital Zhejiang University School of Medicine — Yiwu, Zhejiang, China (Recruiting)
• Yuyao People's Hospital of Zhejiang Province — Yuyao, Zhejiang, China (Not_yet_recruiting)

Study contacts

• Study coordinator: Jian Xu, PhD

Conditions Intrauterine Adhesion; Induced abortion; IUA; anti-adhesion barrier film