Clinical Study on a Novel Anti-adhesion Barrier Film

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

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

Study Overview

• Status: Recruiting
• Conditions: Intrauterine Adhesion
• Intervention / Treatment: Device: anti-adhesion diaphragm

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.

• Study Type: Interventional
• Enrollment (Estimated): 1176
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jian Xu, PhD; Phone Number: 18867961080; Email: xuj@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310000
      • Not yet recruiting
      • The affiliated hospital of Hangzhou Normal University
      • Contact: Peng Hu, Doctor; Phone Number: 13758195580
    • Lishui, Zhejiang, China, 323006
      • Not yet recruiting
      • Lishui Hospital of TCM
      • Contact: Xuefang Lin, Doctor; Phone Number: 18957099226
    • Lishui, Zhejiang, China, 323006
      • Not yet recruiting
      • Lishui People's Hospital
      • Contact: Yongju Ye, Doctor; Phone Number: 18957066129
    • Quzhou, Zhejiang, China, 324000
      • Not yet recruiting
      • Quzhou people's Hospital
      • Contact: Yimei Ji, Doctor; Phone Number: 15606705252
    • Quzhou, Zhejiang, China, 324022
      • Not yet recruiting
      • The Second People's Hospital Of Quzhou, Zhejiang
      • Contact: Xiaoqing Fang, Doctor; Phone Number: 15505708096
    • Wenzhou, Zhejiang, China, 325000
      • Not yet recruiting
      • Wenzhou Central Hospital
      • Contact: Yuhong Yan, PhD; Phone Number: 13867701221
    • Yiwu, Zhejiang, China, 322000
      • Recruiting
      • The Fourth Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Jiang Xu, PhD; Phone Number: 18867961080; Email: xuj@zju.edu.cn
    • Yuyao, Zhejiang, China, 315400
      • Not yet recruiting
      • Yuyao People's Hospital of Zhejiang Province
      • Contact: Jianting Ma, Doctor; Phone Number: 13805802310

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: anti-adhesion diaphragm; Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.	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.
No Intervention: control group; Participants will be treated routinely with no other interventions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
bleeding volume (Normal, decrease, increase)	Menstruation	two week, three months (third menstrual cycle) post-index procedure
Postoperative Menstrual time（days）	Postoperative Menstrual time（days）	two week, three months (third menstrual cycle) post-index procedure
Abdominal pain	Abdominal pain due to postoperative menstruation	two week, three months (third menstrual cycle) post-index procedure
Physician satisfaction checklist	classified as very satisfied, satisfied, general and unsatisfied;	three months (third menstrual cycle) post-index procedure
Patient acceptance chaecklist	willingness to use again and to recommend others;	three months (third menstrual cycle) post-index procedure
Patient comfort after placement checklist	classified as comfortable, general, uncomfortable, and very uncomfortable.	three months (third menstrual cycle) post-index procedure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
body temperature ( ℃)	Vital signs	three months (third menstrual cycle) post-index procedure
breathing (Times/minute)	Vital signs	three months (third menstrual cycle) post-index procedure
blood pressure (mmHg)	Vital signs	three months (third menstrual cycle) post-index procedure
heart rate ( Times/minute)	Vital signs	three months (third menstrual cycle) post-index procedure
Number of Participants With Abnormal Laboratory Values	Abnormal Laboratory Values	three months (third menstrual cycle) post-index procedure
adverse reactions or adverse events	adverse events	three months (third menstrual cycle) post-index procedure

Collaborators and Investigators

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• Investigators: Study Chair: Jian Xu, PhD, The Fourth Affiliated Hospital Zhejiang University School of Medicine

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2023
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: May 14, 2023
• First Submitted That Met QC Criteria: June 2, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Estimated): February 23, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Induced abortion; IUA; anti-adhesion barrier film
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: K2023016

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No