To Study the Safety and Efficacy of A Novel Intrauterine Estrogen-Releasing System in Induced Abortion

N/ANot Yet RecruitingNCT07381569

Peking Union Medical College Hospital200 enrolled

Overview

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: 1. Can the estradiol-loaded silicone rubber intrauterine stent system increase the endometrial thickness at 21+2 days after the procedure? 2. What adverse events or safety issues occur in participants when using this product? Researchers will compare the estradiol-loaded silicone rubber intrauterine stent system with a non-drug-loaded silicone intrauterine stent to determine whether the drug-eluting stent offers advantages in promoting endometrial repair. Participants will: 1. Undergo placement of either the estradiol-eluting stent or the non-drug stent immediately after artificial abortion, with the stent retained for 21+2 days 2. Attend scheduled follow-up visits at 21+2 days, after the first menstruation, and at 90 days post-procedure. 3. Undergo ultrasound examinations to measure endometrial thickness, and record vaginal bleeding duration, blood loss volume, time to first menstruation, and any adverse events

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

200

Conditions

Abortion, Induced

Interventions

Estradiol-Loaded Silicone Rubber Intrauterine Stent SystemDEVICE

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.

No-Drug-Loaded Silicone Rubber Intrauterine Stent SystemDEVICE

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria 1. Female patients aged 18-40 years； 2. Menstrual cycle was 21-35 days within the six months before enrollment； 3. BMI between 18.5-28 kg/m²； 4. Voluntary termination of pregnancy, history of ≥2 abortions or missed abortion, and confirmed gestational age ≤10 weeks； 5. Willing to participate, able to attend regular follow-ups, and sign the informed consent form. Exclusion Criteria 1. Known allergy or contraindication to silicone rubber or estrogen； 2. History of hysteroscopically confirmed uterine adhesions or diagnosed thin endometrium； 3. Uterine malformation, uterine fibroids compressing the uterine cavity, or other causes of abnormal uterine cavity shape； 4. Participants requesting IUD placement, oral contraceptives, or subcutaneous implantation after surgery； 5. Patients with mental or cognitive impairment, unable to cooperate with the treatment process； 6. Patients considered by the investigator to have potential risks or factors making them unsuitable for inclusion.

Outcomes

Primary Outcomes

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.

Time frame: at 21 + 2 Days Postoperatively

Secondary Outcomes

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.

Time frame: 14 days post-surgery

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).

Time frame: 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.

Time frame: 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).

Time frame: 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".