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The purpose of this clinical trial is to evaluate the safety and efficacy of the estradiol-loaded silicone rubber intrauterine stent system for promoting endometrial repair after artificial abortion. The main research questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Estradiol-Loaded Silicone Rubber Intrauterine Stent System | Experimental |
| |
| No-Drug-Loaded Silicone Rubber Intrauterine Stent System | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Estradiol-Loaded Silicone Rubber Intrauterine Stent System | Device | After abortion, an estradiol-loaded silicone rubber intrauterine stent system was placed for 21+2 days, and oral anti-infective medication was administered for 3 days postoperatively. |
| Measure | Description | Time Frame |
|---|---|---|
| Endometrial thickness | Measured via transvaginal ultrasound (unit: mm). The measurement is defined as the maximum perpendicular distance between the interface of the myometrium and endometrium on the anterior and posterior walls of the uterine cavity, obtained from the largest sagittal section of the uterus. | at 21 + 2 Days Postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Vaginal bleeding volume | Assessed by investigator-conducted follow-up interview at 14 days postoperatively. The postoperative vaginal bleeding volume is categorized as less, moderate, or more based on the subject's subjective perception, compared with her pre-operative menstrual flow volume. | 14 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Abnormality rate of blood, biochemical, and hormonal indicators | This outcome measures the proportion of participants with at least one abnormal indicator result. An indicator is defined as abnormal if its value falls outside the clinical normal reference range. The calculation formula is: (Number of participants with ≥1 abnormal result / Total eligible participants) × 100%. Included indicators cover routine blood tests, routine urine tests, coagulation function tests, routine vaginal discharge examination, liver function tests, kidney function tests, estradiol and progesterone levels (specific indicators tested differ by time frame). |
Inclusion Criteria
Exclusion Criteria
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xinyan Liu | Contact | +86 186 0000 8013 | liuxymeng@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Dongcheng | 100010 | China |
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| No-Drug-Loaded Silicone Rubber Intrauterine Stent System | Device | After abortion, a no-drug-loaded silicone rubber intrauterine stent system was placed for 21+2 days, and oral anti-infective medication was administered for 3 days postoperatively. |
|
| Vaginal bleeding duration |
Assess the duration of vaginal bleeding after induced abortion surgery, measured in hours/days (recorded from the end of surgery until bleeding stops). |
| 14 days post-surgery |
| Time to menstrual resumption after abortion | Time interval from the date of induced abortion surgery to the first day of spontaneous vaginal bleeding that meets the patient's usual menstrual flow volume and duration. | Followed up and recorded within 60 days after induced abortion surgery (if no menstruation occurs by day 60, it will be recorded as "no resumption within 60 days"). |
| Changes in menstrual blood volume at first menstrual period post-abortion | Compare the blood volume of the first menstrual period after abortion with the patient's pre-pregnancy usual menstrual blood volume (assessed via patient-reported sanitary product usage). | Assessed at the end of the first menstrual period after abortion, with follow-up and recording completed within 60 days post-abortion.If no menstruation occurs by day 60, it will be recorded as "no resumption within 60 days". |
| Pre-surgery: All 8 abovementioned indicators are tested and included in the abnormality rate calculation. 21 ± 2 days post-surgery: Only liver function tests, kidney function tests, estradiol and progesterone levels are tested. |
| Positive rate of bacterial culture on intrauterine stent surface | This outcome measure assesses intrauterine stent-related infection risk by culturing the patient's fluid samples from the stent surface. The specific method is to gently wipe the stent surface with a sterile swab to collect the patient's fluid. The "positive rate of bacterial culture on intrauterine stent surface" refers to the proportion of stents with positive bacterial culture results. | After stent removal at 21±2 days after surgery |