Clinical Study on a Novel Anti-adhesion Barrier Film

NCT05888545 | Recruiting DMC

• 1 other identifier: K2023016
• Study Type: interventional
• Target: 1,176
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Intrauterine Adhesion

Keywords

Induced abortion; IUA; anti-adhesion barrier film

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• bleeding volume (Normal, decrease, increase)

  two week, three months (third menstrual cycle) post-index procedure

• Postoperative Menstrual time（days）

  two week, three months (third menstrual cycle) post-index procedure

• Abdominal pain

  two week, three months (third menstrual cycle) post-index procedure

• Physician satisfaction checklist

  three months (third menstrual cycle) post-index procedure

• Patient acceptance chaecklist

  three months (third menstrual cycle) post-index procedure

Other Outcomes (6)

• Number of Participants With Abnormal Laboratory Values

  three months (third menstrual cycle) post-index procedure

• body temperature ( ℃)

  three months (third menstrual cycle) post-index procedure

• breathing (Times/minute)

  three months (third menstrual cycle) post-index procedure

Study Arms (2)

anti-adhesion diaphragm

EXPERIMENTAL

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

control group

NO INTERVENTION

Participants will be treated routinely with no other interventions.

Interventions

anti-adhesion diaphragm DEVICE

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

anti-adhesion diaphragm

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Fourth Affiliated Hospital of Zhejiang University School of Medicine: lead

Study Sites (8)

The Affiliated Hospital of Hangzhou Normal University

Hangzhou, Zhejiang, 310000, China

NOT YET RECRUITING

Lishui Hospital of TCM

Lishui, Zhejiang, 323006, China

NOT YET RECRUITING

Lishui People's Hospital

Lishui, Zhejiang, 323006, China

NOT YET RECRUITING

Quzhou People's Hospital

Quzhou, Zhejiang, 324000, China

NOT YET RECRUITING

The Second People's Hospital Of Quzhou, Zhejiang

Quzhou, Zhejiang, 324022, China

NOT YET RECRUITING

Wenzhou Central Hospital

Wenzhou, Zhejiang, 325000, China

NOT YET RECRUITING

The Fourth Affiliated Hospital Zhejiang University School of Medicine

Yiwu, Zhejiang, 322000, China

RECRUITING

Yuyao People's Hospital of Zhejiang Province

Yuyao, Zhejiang, 315400, China

NOT YET RECRUITING

Related Publications (3)

• 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.

  PMID: 33320197 BACKGROUND

• 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.

  PMID: 30936754 BACKGROUND

• 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.

  PMID: 26534897 BACKGROUND

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Jian Xu, PhD

  The Fourth Affiliated Hospital Zhejiang University School of Medicine

  STUDY CHAIR

Central Study Contacts

Jian Xu, PhD

CONTACT

18867961080; xuj@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2023
• First Posted: June 5, 2023
• Study Start: April 1, 2023
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: February 23, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (8)