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The aim of this clinical study was to verify the effectiveness and safety of the anti-adhesion diaphragm in preventing intrauterine adhesions.
The main questions it aims to answer are
The researchers will compare the two groups to see if it is effective in clinical practice.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| control group | No Intervention | Participants will be treated routinely with no other interventions. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| 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 |
| 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） |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Abnormal Laboratory Values | Abnormal Laboratory Values | three months (third menstrual cycle) post-index procedure |
| body temperature ( ℃) | Vital signs |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jian Xu, PhD | Contact | 18867961080 | xuj@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jian Xu, PhD | The Fourth Affiliated Hospital Zhejiang University School of Medicine | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Hospital of Hangzhou Normal University | Not yet recruiting | Hangzhou | Zhejiang | 310000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33320197 | Background | 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. | |
| 30936754 | Background |
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| ID | Term |
|---|---|
| D006175 | Gynatresia |
| ID | Term |
|---|---|
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| 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 |
| 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 |
| adverse reactions or adverse events | adverse events | three months (third menstrual cycle) post-index procedure |
| Lishui Hospital of TCM | Not yet recruiting | Lishui | Zhejiang | 323006 | China |
|
| Lishui People's Hospital | Not yet recruiting | Lishui | Zhejiang | 323006 | China |
|
| Quzhou People's Hospital | Not yet recruiting | Quzhou | Zhejiang | 324000 | China |
|
| The Second People's Hospital Of Quzhou, Zhejiang | Not yet recruiting | Quzhou | Zhejiang | 324022 | China |
|
| Wenzhou Central Hospital | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
|
| The Fourth Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Yiwu | Zhejiang | 322000 | China |
|
| Yuyao People's Hospital of Zhejiang Province | Not yet recruiting | Yuyao | Zhejiang | 315400 | China |
|
| 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. |
| 26534897 | 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. |
| D000091662 | Genital Diseases |