Clinical Study on a Novel Anti-adhesion Barrier Film

Intrauterine Adhesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888545
• Other study ID #: K2023016
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Contact: Jian Xu, PhD
• Phone: 18867961080
• Email: xuj[@]zju.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1176
• Est. completion date: December 31, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Intrauterine Adhesion
• Tissue Adhesions

Intervention

Device:
• anti-adhesion diaphragm
Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.

Locations

Country	Name	City	State
China	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang
China	Lishui Hospital of TCM	Lishui	Zhejiang
China	Lishui People's Hospital	Lishui	Zhejiang
China	Quzhou People's Hospital	Quzhou	Zhejiang
China	The Second People's Hospital Of Quzhou, Zhejiang	Quzhou	Zhejiang
China	Wenzhou Central Hospital	Wenzhou	Zhejiang
China	The Fourth Affiliated Hospital Zhejiang University School of Medicine	Yiwu	Zhejiang
China	Yuyao People's Hospital of Zhejiang Province	Yuyao	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Abnormal Laboratory Values	Abnormal Laboratory Values	three months (third menstrual cycle) post-index procedure
Other	body temperature ( ?)	Vital signs	three months (third menstrual cycle) post-index procedure
Other	breathing (Times/minute)	Vital signs	three months (third menstrual cycle) post-index procedure
Other	blood pressure (mmHg)	Vital signs	three months (third menstrual cycle) post-index procedure
Other	heart rate ( Times/minute)	Vital signs	three months (third menstrual cycle) post-index procedure
Other	adverse reactions or adverse events	adverse events	three months (third menstrual cycle) post-index procedure
Primary	Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.	The incidence of uterine adhesions was defined as the incidence of uterine adhesions in the control group of subjects with the uterine anti-adhesion septum placed to block the anterior and posterior uterine wall contact, and the incidence of adhesions in both groups was evaluated by ultrasound and/or hysteroscopy in the 3rd postoperative menstrual cycle.	one week before the third menstrual cycle post-index procedure
Secondary	bleeding volume (Normal, decrease, increase)	Menstruation	two week, three months (third menstrual cycle) post-index procedure
Secondary	Postoperative Menstrual time(days)	Postoperative Menstrual time(days)	two week, three months (third menstrual cycle) post-index procedure
Secondary	Abdominal pain	Abdominal pain due to postoperative menstruation	two week, three months (third menstrual cycle) post-index procedure
Secondary	Physician satisfaction checklist	classified as very satisfied, satisfied, general and unsatisfied;	three months (third menstrual cycle) post-index procedure
Secondary	Patient acceptance chaecklist	willingness to use again and to recommend others;	three months (third menstrual cycle) post-index procedure
Secondary	Patient comfort after placement checklist	classified as comfortable, general, uncomfortable, and very uncomfortable.	three months (third menstrual cycle) post-index procedure