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Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.
Study Objectives: To evaluate the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesions formation after dilatation and curettage.
Design: Randomized controlled trial. Settings: Six hospitals for maternal and child health care in China. Patients: Three hundred women undergoing dilatation and curettage for delayed miscarriage without previous dilatation and curettage.
Interventions: Women were randomly assigned into either dilatation and curettage alone group or dilatation and curettage plus new crosslinked hyaluronan gel application group with 1:1 allocation.
Measurements and Outcomes: All patients were evaluated using American Fertility Society classification of IUAs during the follow-up diagnostic hysteroscopy, scheduled 3 months after dilatation and curettage procedure. The primary outcome was the number of women with IUAs, and the secondary outcome was the adhesion scores and the severity of IUAs.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment | Experimental | At the end of the dilatation and curettage, new crosslinked hyaluronan gel (3ml) was applied to the uterine cavity in women assigned to the treatment group through a 15-cm sterile cannula. |
|
| Control | No Intervention | At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| new crosslinked hyaluronan gel | Device | At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of intrauterine adhesion | The number of women with intrauterine adhesion | 3 months after dilatation and curettage |
| Measure | Description | Time Frame |
|---|---|---|
| The adhesion scores of extent of uterine cavity involved | Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (<1/3 cavity with adhesion), 2 points (1/3-2/3 cavity with adhesion) and 4 points (>2/3 cavity with adhesion), high values represent worse outcome | 3 months after dilatation and curettage |
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The inclusion criteria:
The exclusion criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29678756 | Derived | Li X, Wu L, Zhou Y, Fan X, Huang J, Wu J, Yu R, Lou J, Yang M, Yao Z, Xue M. New Crosslinked Hyaluronan Gel for the Prevention of Intrauterine Adhesions after Dilation and Curettage in Patients with Delayed Miscarriage: A Prospective, Multicenter, Randomized, Controlled Trial. J Minim Invasive Gynecol. 2019 Jan;26(1):94-99. doi: 10.1016/j.jmig.2018.03.032. Epub 2018 Apr 17. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 9, 2016 | Nov 23, 2017 | Prot_SAP_000.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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| The adhesion scores of type of adhesion | Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 1 point (filmy adhesion), 2 points (filmy & dense adhesion) and 4 points (dense adhesion), high values represent worse outcome | 3 months after dilatation and curettage |
| The adhesion scores of menstrual pattern | Evaluated according to American Fertility Society classification of intrauterine adhesion during the follow-up diagnostic hysteroscopy: 0 point (normal), 2 points (hypomenorrhea) and 4 points (amenorrhea), high values represent worse outcome | 3 months after dilatation and curettage |
| Cumulative adhesion score | The summed score of the adhesion scores of extent of uterine cavity involved, type of adhesion and menstrual pattern; range: 1-12 points, high values represent worse outcome | 3 months after dilatation and curettage |
| Severity | Graded according to cumulative adhesion score: Stage I (mild)(1-4 points), Stage II (moderate)(5-8 points) and Stage III (severe)(9-12 points). | 3 months after dilatation and curettage |
| D000091662 | Genital Diseases |