Clinical trial NCT05888545: Clinical Study on a Novel Anti-adhesion Barrier Film
Official title: A Randomized Controlled Study on an Anti-adhesion Diaphragm in Preventing Intrauterine Adhesions
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Intrauterine Adhesion
Keywords: Induced abortion
IUA
anti-adhesion barrier film
Lead sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
Sponsor class: OTHER
First posted: 2023-06-05
Enrollment: 1176
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions.

Detailed description: The main questions it aims to answer are

* The efficacy of the anti-adhesion diaphragm in preventing intrauterine adhesions;
* The duration of placement of the anti-adhesion septum in the uterus. Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure. The control group will receive conventional treatment with no other interventions.

The researchers will compare the two groups to see if it is effective in clinical practice.

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.

Primary outcomes:
measure: Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.
timeFrame: one week before the third menstrual cycle post-index procedure
Secondary outcomes:
measure: bleeding volume (Normal, decrease, increase)
timeFrame: two week, three months (third menstrual cycle) post-index procedure
measure: Postoperative Menstrual time（days）
timeFrame: two week, three months (third menstrual cycle) post-index procedure
measure: Abdominal pain
timeFrame: two week, three months (third menstrual cycle) post-index procedure
measure: Physician satisfaction checklist
timeFrame: three months (third menstrual cycle) post-index procedure
measure: Patient acceptance chaecklist
timeFrame: three months (third menstrual cycle) post-index procedure
measure: Patient comfort after placement checklist
timeFrame: three months (third menstrual cycle) post-index procedure
Other outcomes:
measure: Number of Participants With Abnormal Laboratory Values
timeFrame: three months (third menstrual cycle) post-index procedure
measure: body temperature ( ℃)
timeFrame: three months (third menstrual cycle) post-index procedure
measure: breathing (Times/minute)
timeFrame: three months (third menstrual cycle) post-index procedure
measure: blood pressure (mmHg)
timeFrame: three months (third menstrual cycle) post-index procedure
measure: heart rate ( Times/minute)
timeFrame: three months (third menstrual cycle) post-index procedure
measure: adverse reactions or adverse events
timeFrame: three months (third menstrual cycle) post-index procedure
Locations:
city: Hangzhou
country: China
facility: The Affiliated Hospital of Hangzhou Normal University
state: Zhejiang
city: Lishui
country: China
facility: Lishui Hospital of TCM
state: Zhejiang
city: Lishui
country: China
facility: Lishui People's Hospital
state: Zhejiang
city: Quzhou
country: China
facility: Quzhou People's Hospital
state: Zhejiang
city: Quzhou
country: China
facility: The Second People's Hospital Of Quzhou, Zhejiang
state: Zhejiang
city: Wenzhou
country: China
facility: Wenzhou Central Hospital
state: Zhejiang
city: Yiwu
country: China
facility: The Fourth Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
city: Yuyao
country: China
facility: Yuyao People's Hospital of Zhejiang Province
state: Zhejiang
Study officials:
affiliation: The Fourth Affiliated Hospital Zhejiang University School of Medicine
name: Jian Xu, PhD
role: STUDY_CHAIR
References:
citation: Hooker AB, de Leeuw RA, Twisk JWR, Brolmann HAM, Huirne JAF. Reproductive performance of women with and without intrauterine adhesions following recurrent dilatation and curettage for miscarriage: long-term follow-up of a randomized controlled trial. Hum Reprod. 2021 Jan 1;36(1):70-81. doi: 10.1093/humrep/deaa289.
citation: Dreisler E, Kjer JJ. Asherman's syndrome: current perspectives on diagnosis and management. Int J Womens Health. 2019 Mar 20;11:191-198. doi: 10.2147/IJWH.S165474. eCollection 2019.
citation: Lemmers M, Verschoor MA, Hooker AB, Opmeer BC, Limpens J, Huirne JA, Ankum WM, Mol BW. Dilatation and curettage increases the risk of subsequent preterm birth: a systematic review and meta-analysis. Hum Reprod. 2016 Jan;31(1):34-45. doi: 10.1093/humrep/dev274. Epub 2015 Nov 2.