Intrauterine AdhesionNCT05888545
Clinical Study on a Novel Anti-adhesion Barrier Film
A study testing anti-adhesion diaphragm in people with Intrauterine Adhesion, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 8 sites in China.
Trial summary
The aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Intrauterine Adhesion
- What is being tested?
- anti-adhesion diaphragm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,176 participants
- Where
- 8 sitesChina
- Study dates
- 1 Apr 2023to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites, 8 recruiting
- Not yet recruiting
The Affiliated Hospital of Hangzhou Normal University
Hangzhou, Zhejiang, 310000
Peng Hu, Doctor, 13758195580
- Not yet recruiting
Lishui Hospital of TCM
Lishui, Zhejiang, 323006
Xuefang Lin, Doctor, 18957099226
- Not yet recruiting
Lishui People's Hospital
Lishui, Zhejiang, 323006
Yongju Ye, Doctor, 18957066129
- Not yet recruiting
Quzhou People's Hospital
Quzhou, Zhejiang, 324000
Yimei Ji, Doctor, 15606705252
- Not yet recruiting
The Second People's Hospital Of Quzhou, Zhejiang
Quzhou, Zhejiang, 324022
Xiaoqing Fang, Doctor, 15505708096
- Not yet recruiting
Wenzhou Central Hospital
Wenzhou, Zhejiang, 325000
Yuhong Yan, PhD, 13867701221
- Recruiting
The Fourth Affiliated Hospital Zhejiang University School of Medicine
Yiwu, Zhejiang, 322000
Jiang Xu, PhD, 18867961080, xuj@zju.edu.cn
- Not yet recruiting
Yuyao People's Hospital of Zhejiang Province
Yuyao, Zhejiang, 315400
Jianting Ma, Doctor, 13805802310
About this study
Official title: 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.
Read the 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.
- Conditions
- Intrauterine Adhesion
- Being tested
- anti-adhesion diaphragm
- Keywords
- Induced abortion, IUA, anti-adhesion barrier film
- Medical subject headings
- Gynatresia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-adhesion diaphragmDevice
Participants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: anti-adhesion diaphragm |
| control group | No intervention | Participants will be treated routinely with no other interventions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one week before the third menstrual cycle post-index procedure
Secondary outcomes (6)
bleeding volume (Normal, decrease, increase)
Menstruation
Measured: two week, three months (third menstrual cycle) post-index procedure
Postoperative Menstrual time（days）
Postoperative Menstrual time（days）
Measured: two week, three months (third menstrual cycle) post-index procedure
Abdominal pain
Abdominal pain due to postoperative menstruation
Measured: two week, three months (third menstrual cycle) post-index procedure
Physician satisfaction checklist
classified as very satisfied, satisfied, general and unsatisfied;
Measured: three months (third menstrual cycle) post-index procedure
Patient acceptance chaecklist
willingness to use again and to recommend others;
Measured: three months (third menstrual cycle) post-index procedure
Patient comfort after placement checklist
classified as comfortable, general, uncomfortable, and very uncomfortable.
Measured: three months (third menstrual cycle) post-index procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start1 Apr 2023
- Primary completion1 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Intrauterine AdhesionStudies of the same condition, open and under way.
- More trials run by The Fourth Affiliated Hospital of Zhejiang University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,176 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jian Xu, PhD, Study chair, The Fourth Affiliated Hospital Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888545
- Sponsor's protocol ID
- K2023016
- Status last verified
- Feb 2024
- First submitted
- 14 May 2023
- Last updated
- 23 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33320197Dreisler 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.
PubMed 30936754Lemmers 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.
PubMed 26534897
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Study on an Anti-adhesion Diaphragm in Preventing Intrauterine Adhesions
- ClinicalTrials.gov ID
- NCT05888545
- Acronym / sponsor ID
- K2023016
- Conditions
- Intrauterine Adhesion
- Keywords
- Induced abortion, IUA, anti-adhesion barrier film
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,176 participants (estimated)
- Lead sponsor
- The Fourth Affiliated Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| anti-adhesion diaphragm | Experimental | Device: anti-adhesion diaphragmParticipants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure. |
| control group | No intervention | –Participants will be treated routinely with no other interventions. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| anti-adhesion diaphragmParticipants will be asked to place an anti-adhesion diaphragm in the uterus for 3-7 days after the abortion procedure. | Device | anti-adhesion diaphragm |
Primary outcome
Incidence of uterine adhesions in the 3rd postoperative menstrual cycle.
Time frame: 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.
6 secondary outcomes
bleeding volume (Normal, decrease, increase)
Time frame: two week, three months (third menstrual cycle) post-index procedure
Postoperative Menstrual time（days）
Time frame: two week, three months (third menstrual cycle) post-index procedure
Abdominal pain
Time frame: two week, three months (third menstrual cycle) post-index procedure
Physician satisfaction checklist
Time frame: three months (third menstrual cycle) post-index procedure
Patient acceptance chaecklist
Time frame: three months (third menstrual cycle) post-index procedure
Patient comfort after placement checklist
Time frame: three months (third menstrual cycle) post-index procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2024.
- Background: PubMed 33320197Hooker 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.
- Background: PubMed 30936754Dreisler 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.
- Background: PubMed 26534897Lemmers 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.
- Individual participant dataSharing planned: No
Related trials for Intrauterine Adhesion
RecruitingObservational study
Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions
Pregnancy Complicated With Intrauterine Adhesion
Recruiting
Prevention of Intra-uterine Adhesions Following Laparoscopic and Laparotomic Myomectomy
Myoma
Recruiting
Intrauterine Stent Placement Following Hysteroscopic Septum Resection
Intrauterine Adhesion
Recruiting
To Evaluate the Safety and Effectiveness of Intrauterine Adhesion Preventer in the Prevention and Treatment of Intrauterine Adhesions, a Prospective, Multicenter, Randomized Controlled Clinical Trial
Intrauterine Adhesion, Intrauterine Adhesions
Not yet recruiting
Clinical Study of i-PRF Intrauterine Perfusion for Endometrial Regeneration and Repair in Moderate to Severe Intrauterine Adhesions
Intrauterine Adhesions
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jian Xu, PhD study chair
The Fourth Affiliated Hospital Zhejiang University School of Medicine
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-adhesion diaphragm in people with Intrauterine Adhesion, run by The Fourth Affiliated Hospital of Zhejiang University School of Medicine at 8 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jian Xu, PhD (18867961080, xuj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of uterine adhesions in the 3rd postoperative menstrual cycle. (time frame: one week before the third menstrual cycle post-index procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05888545, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2024.