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This study was taken out to compare two mechanical devices (intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.
Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both effective in the therapy for intrauterine adhesion.
The Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed two or three month later.
The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intrauterine balloon | Experimental | The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two or three months to re-evaluate the uterine adhesions. |
|
| intrauterine device Plus Foley Catheter | Experimental | Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intrauterine balloon | Device | After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. |
| Measure | Description | Time Frame |
|---|---|---|
| the AFS Score at Second-look Hysteroscopy | The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is. | 2 or 3 months after the surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Feng Lin, MD | First Affiliated Hospital of Wenzhou Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the 1st Affiliated Hospital of Wenzhou Medical University | Wenzhou | Zhejiang | 325000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25936237 | Background | Lin XN, Zhou F, Wei ML, Yang Y, Li Y, Li TC, Zhang SY. Randomized, controlled trial comparing the efficacy of intrauterine balloon and intrauterine contraceptive device in the prevention of adhesion reformation after hysteroscopic adhesiolysis. Fertil Steril. 2015 Jul;104(1):235-40. doi: 10.1016/j.fertnstert.2015.04.008. Epub 2015 Apr 30. | |
| 23933351 |
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all patients were recruited from 1st affiliated hospital of Wenzhou Medical University.
Inclusion criteria were as follows:1) women aged 18 to 45 years. 2) agreed to have second-look hysteroscopy. 3) moderate to severe intrauterine adhesion (AFS score ≥5)
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| ID | Title | Description |
|---|---|---|
| FG000 | Intrauterine Balloon | After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions. |
| FG001 | Intrauterine Contraceptive Device Plus Foley Catheter | Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intrauterine Balloon | After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.And hysteroscopy was taken out again after two menstrual cycles to evaluate the uterine adhesions. |
| BG001 | IUD Plus Foley Catheter |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | the AFS Score at Second-look Hysteroscopy | The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is. | Posted | Median | Full Range | Units on a scale | 2 or 3 months after the surgery |
|
6 months to 1 year
Among 171 participants who were initially recruited, 18 were excluded from analysis; 8 patients declined to participate and 10 patients did not meet the inclusion criteria. 30 participants subsequently refused to undergo the second-look hysteroscopy, and 5 subjects were also excluded for protocol violation. 17 women in the study reported side effects. 15 subjects suffered from moderate to severe postoperative pain; 12in the COOK balloon stent group and 3 in the IUD plus Foley catheter group.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intrauterine Balloon | After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week. And hysteroscopy was taken out again after two or three menstrual cycles to evaluate the uterine adhesions. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| suffered from moderate to severe postoperative pain | Injury, poisoning and procedural complications | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| the 1st affiliated hospital of Wenzhou Medical University. | the 1st affiliated hospital of Wenzhou Medical University. | 0886-0577-88069525 | zfy983023@hotmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 1, 2017 | Dec 27, 2017 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Dec 1, 2017 | Oct 9, 2018 | Prot_001.pdf |
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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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| ID | Term |
|---|---|
| D007434 | Intrauterine Devices |
| ID | Term |
|---|---|
| D003274 | Contraceptive Devices, Female |
| D003273 | Contraceptive Devices |
| D004864 | Equipment and Supplies |
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| Intrauterine Contraceptive Device Plus Foley Catheter | Device | After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy. |
|
|
| Johary J, Xue M, Zhu X, Xu D, Velu PP. Efficacy of estrogen therapy in patients with intrauterine adhesions: systematic review. J Minim Invasive Gynecol. 2014 Jan-Feb;21(1):44-54. doi: 10.1016/j.jmig.2013.07.018. Epub 2013 Aug 9. |
| 23932377 | Background | Lin X, Wei M, Li TC, Huang Q, Huang D, Zhou F, Zhang S. A comparison of intrauterine balloon, intrauterine contraceptive device and hyaluronic acid gel in the prevention of adhesion reformation following hysteroscopic surgery for Asherman syndrome: a cohort study. Eur J Obstet Gynecol Reprod Biol. 2013 Oct;170(2):512-6. doi: 10.1016/j.ejogrb.2013.07.018. Epub 2013 Aug 7. |
Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy. |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Parity | Mean | Standard Deviation | Births |
|
Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while Intrauterine Device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy. Intrauterine Contraceptive Device Plus Foley Catheter: After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy. |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| 21 |
| 83 |
| EG001 | IUD Plus Foley Catheter | Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after a hysteroscopic adhesiolysis. Foley Catheter is removed after three days while IUD removed at the second hysteroscopy. Uterine adhesions were judged again at the second hysteroscopy. | 0 | 88 | 0 | 88 | 32 | 88 |
| refuse to have second-look hysteroscopy | Investigations | MedDRA 10.0 | Systematic Assessment | excluded |
|
| Protocol violation | Investigations | MedDRA 10.0 | Systematic Assessment | excluded |
|
| Declined to participate | Investigations | MedDRA 10.0 | Systematic Assessment | excluded |
|
| Not meeting inclusion criteria | Investigations | MedDRA 10.0 | Systematic Assessment | excluded |
|
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| D000091662 | Genital Diseases |