Clinical Study on a Novel Anti-adhesion Barrier Film

• Sponsor: The Fourth Affiliated Hospital of Zhejiang University School of Medicine (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05888545
• Collaborator: (none)
• Enrollment: 1,176
• Locations: 8
• Arms: 2
• Anticipated Duration (Months): 9
• Patients Per Site: 147
• Patients Per Site Per Month: 16.3

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Intrauterine Adhesion	Device: anti-adhesion diaphragm	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 1176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: A Randomized Controlled Study on an Anti-adhesion Diaphragm in Preventing Intrauterine Adhesions
• Actual Study Start Date: Apr 1, 2023
• Anticipated Primary Completion Date: Dec 1, 2023
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Incidence of uterine adhesions in the 3rd postoperative menstrual cycle. [one week before the third menstrual cycle post-index procedure]

   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

1. bleeding volume (Normal, decrease, increase) [two week, three months (third menstrual cycle) post-index procedure]

   Menstruation

2. Postoperative Menstrual time（days） [two week, three months (third menstrual cycle) post-index procedure]

   Postoperative Menstrual time（days）

3. Abdominal pain [two week, three months (third menstrual cycle) post-index procedure]

   Abdominal pain due to postoperative menstruation

4. Physician satisfaction checklist [three months (third menstrual cycle) post-index procedure]

   classified as very satisfied, satisfied, general and unsatisfied;

5. Patient acceptance chaecklist [three months (third menstrual cycle) post-index procedure]

   willingness to use again and to recommend others;

6. Patient comfort after placement checklist [three months (third menstrual cycle) post-index procedure]

   classified as comfortable, general, uncomfortable, and very uncomfortable.

Other Outcome Measures

1. Number of Participants With Abnormal Laboratory Values [three months (third menstrual cycle) post-index procedure]

   Abnormal Laboratory Values

2. body temperature ( ℃) [three months (third menstrual cycle) post-index procedure]

   Vital signs

3. breathing (Times/minute) [three months (third menstrual cycle) post-index procedure]

   Vital signs

4. blood pressure (mmHg) [three months (third menstrual cycle) post-index procedure]

   Vital signs

5. heart rate ( Times/minute) [three months (third menstrual cycle) post-index procedure]

   Vital signs

6. adverse reactions or adverse events [three months (third menstrual cycle) post-index procedure]

   adverse events

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 40 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Affiliated Hospital of Hangzhou Normal University	Hangzhou	Zhejiang	China	310000
2	Lishui Hospital of TCM	Lishui	Zhejiang	China	323006
3	Lishui People's Hospital	Lishui	Zhejiang	China	323006
4	Quzhou People's Hospital	Quzhou	Zhejiang	China	324000
5	The Second People's Hospital Of Quzhou, Zhejiang	Quzhou	Zhejiang	China	324022
6	Wenzhou Central Hospital	Wenzhou	Zhejiang	China	325000
7	The Fourth Affiliated Hospital Zhejiang University School of Medicine	Yiwu	Zhejiang	China	322000
8	Yuyao People's Hospital of Zhejiang Province	Yuyao	Zhejiang	China	315400

Sponsors and Collaborators

• 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

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.

• Responsible Party: The Fourth Affiliated Hospital of Zhejiang University School of Medicine
• ClinicalTrials.gov Identifier: NCT05888545
• Other Study ID Numbers: K2023016
• First Posted: Jun 5, 2023
• Last Update Posted: Jun 12, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The Fourth Affiliated Hospital of Zhejiang University School of Medicine: Induced abortion; IUA; anti-adhesion barrier film
• Additional relevant MeSH terms: Tissue Adhesions

Study Results

No Results Posted as of Jun 12, 2023