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Clinical Study on a Novel Anti-adhesion Barrier Film

Primary Purpose

Intrauterine Adhesion

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
anti-adhesion diaphragm
Sponsored by
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Intrauterine Adhesion focused on measuring Induced abortion, IUA, anti-adhesion barrier film

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Affiliated Hospital of Hangzhou Normal University
  • Lishui Hospital of TCM
  • Lishui People's Hospital
  • Quzhou People's Hospital
  • The Second People's Hospital Of Quzhou, Zhejiang
  • Wenzhou Central Hospital
  • The Fourth Affiliated Hospital Zhejiang University School of Medicine
  • Yuyao People's Hospital of Zhejiang Province

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

anti-adhesion diaphragm

control group

Arm Description

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

Participants will be treated routinely with no other interventions.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

bleeding volume (Normal, decrease, increase)
Menstruation
Postoperative Menstrual time（days）
Postoperative Menstrual time（days）
Abdominal pain
Abdominal pain due to postoperative menstruation
Physician satisfaction checklist
classified as very satisfied, satisfied, general and unsatisfied;
Patient acceptance chaecklist
willingness to use again and to recommend others;
Patient comfort after placement checklist
classified as comfortable, general, uncomfortable, and very uncomfortable.

Full Information

First Posted
May 14, 2023
Last Updated
June 9, 2023
Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT05888545
Brief Title
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

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2023 (Actual)
Primary Completion Date
December 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The Fourth Affiliated Hospital of Zhejiang University School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intrauterine Adhesion
Keywords
Induced abortion, IUA, anti-adhesion barrier film

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
1176 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-adhesion diaphragm
Arm Type
Experimental
Arm Description
Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.
Arm Title
control group
Arm Type
No Intervention
Arm Description
Participants will be treated routinely with no other interventions.
Intervention Type
Device
Intervention Name(s)
anti-adhesion diaphragm
Intervention Description
Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.
Primary Outcome Measure Information:
Title
Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.
Description
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.
Time Frame
one week before the third menstrual cycle post-index procedure
Secondary Outcome Measure Information:
Title
bleeding volume (Normal, decrease, increase)
Description
Menstruation
Time Frame
two week, three months (third menstrual cycle) post-index procedure
Title
Postoperative Menstrual time（days）
Description
Postoperative Menstrual time（days）
Time Frame
two week, three months (third menstrual cycle) post-index procedure
Title
Abdominal pain
Description
Abdominal pain due to postoperative menstruation
Time Frame
two week, three months (third menstrual cycle) post-index procedure
Title
Physician satisfaction checklist
Description
classified as very satisfied, satisfied, general and unsatisfied;
Time Frame
three months (third menstrual cycle) post-index procedure
Title
Patient acceptance chaecklist
Description
willingness to use again and to recommend others;
Time Frame
three months (third menstrual cycle) post-index procedure
Title
Patient comfort after placement checklist
Description
classified as comfortable, general, uncomfortable, and very uncomfortable.
Time Frame
three months (third menstrual cycle) post-index procedure
Other Pre-specified Outcome Measures:
Title
Number of Participants With Abnormal Laboratory Values
Description
Abnormal Laboratory Values
Time Frame
three months (third menstrual cycle) post-index procedure
Title
body temperature ( ℃)
Description
Vital signs
Time Frame
three months (third menstrual cycle) post-index procedure
Title
breathing (Times/minute)
Description
Vital signs
Time Frame
three months (third menstrual cycle) post-index procedure
Title
blood pressure (mmHg)
Description
Vital signs
Time Frame
three months (third menstrual cycle) post-index procedure
Title
heart rate ( Times/minute)
Description
Vital signs
Time Frame
three months (third menstrual cycle) post-index procedure
Title
adverse reactions or adverse events
Description
adverse events
Time Frame
three months (third menstrual cycle) post-index procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jian Xu, PhD
Organizational Affiliation
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
The Affiliated Hospital of Hangzhou Normal University
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Facility Name
Lishui Hospital of TCM
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323006
Country
China
Facility Name
Lishui People's Hospital
City
Lishui
State/Province
Zhejiang
ZIP/Postal Code
323006
Country
China
Facility Name
Quzhou People's Hospital
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324000
Country
China
Facility Name
The Second People's Hospital Of Quzhou, Zhejiang
City
Quzhou
State/Province
Zhejiang
ZIP/Postal Code
324022
Country
China
Facility Name
Wenzhou Central Hospital
City
Wenzhou
State/Province
Zhejiang
ZIP/Postal Code
325000
Country
China
Facility Name
The Fourth Affiliated Hospital Zhejiang University School of Medicine
City
Yiwu
State/Province
Zhejiang
ZIP/Postal Code
322000
Country
China
Facility Name
Yuyao People's Hospital of Zhejiang Province
City
Yuyao
State/Province
Zhejiang
ZIP/Postal Code
315400
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33320197
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.
Results Reference
background
PubMed Identifier
30936754
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.
Results Reference
background
PubMed Identifier
26534897
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.
Results Reference
background

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Clinical Study on a Novel Anti-adhesion Barrier Film

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