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Recruiting NCT07883057

Comparison of Operative Hysteroscopy and Vacuum Aspiration for Terminating First-trimester Pregnancy With Intrauterine Adhesions

Conditions: Pregnancy Complicated With Intrauterine Adhesion

Sex: Female
Ages: 18 Years – 40 Years
Healthy volunteers: No
Enrollment: 360
Sponsor: Women's Hospital School Of Medicine Zhejiang University

Location: Women's Hospital, Zhejiang University School of Medicine Hangzhou

Summary

In cases of early pregnancy complicated with intrauterine adhesions (IUAs), termination of pregnancy is prone to incomplete abortion with retained gestational products, failed abortion or uterine perforation due to altered uterine cavity structure and gestational sac obscured by adhesive bands. Reoperation may even be required, which increases the risk of surgical trauma, as well as the psychological and financial burdens on patients. Meanwhile, some patients with IUAs still have fertility demands in the future, so the adhesions also need to be addressed. Hysteroscopy allows direct visualization to remove intrauterine gestational contents, lowering the risks of tissue retention and reoperation. It also enables concurrent treatment of existing IUAs. Combined with postoperative interventions to prevent adhesion recurrence, this approach can restore the uterine cavity structure and endometrium, improve subsequent fertility, and reduce patients' psychological stress as well as the time and economic costs incurred by repeated hospital admissions and surgeries for IUAs. This clinical controlled study aims to explore the clinical outcomes and advantages of hysteroscopy applied for termination of early pregnancy combined with simultaneous management of IUAs, so as to provide reliable evidence for the clinical application of combined hysteroscopic abortion and adhesiolysis in such patients. In addition, immunohistochemical detection of decidual tissues will be performed to analyze the influences of immune cell subsets, inflammatory markers, vascular remodeling-related markers and other indicators on the disease, offering references for its clinical management and treatment. This is a prospective controlled study. Eligible patients diagnosed with early pregnancy complicated with IUAs who underwent pregnancy termination in the Family Planning Ward of our hospital will be enrolled from the date of ethical approval in accordance with the inclusion and exclusion criteria. Patients are divided into two groups: the experimental group receives hysteroscopic abortion combined with simultaneous adhesiolysis, and the control group undergoes ultrasound-guided artificial abortion. After being fully informed of the pros and cons of both surgical procedures, patients will select their preferred operation voluntarily. General patient information will be recorded, including age, obstetric history, fetal viability of the current pregnancy, intraoperative blood loss, placement of anti-adhesive materials in the uterine cavity and postoperative estrogen administration. Postoperative follow-up will be conducted for 2 years after the enrollment of the last subject, with observed indicators including the rate of residual gestational tissue, recurrence rate of IUAs and subsequent pregnancy outcomes. Appropriate statistical descriptive indicators and analytical methods will be selected based on the research objectives, data types and distribution characteristics. Statistical differences and clinical implications between the two surgical protocols will be compared and analyzed

Eligibility Criteria

Inclusion Criteria: 1. patients with transvaginal ultrasound findings suggestive of IUA; 2. patients who underwent follow-up postoperative ultrasound examinations for 3 or more months at the study hospital; 3. patients with a desire to bear children; 4. patients with no significant organic diseases. Exclusion Criteria: 1. patients with ectopic pregnancies, e.g., a cesarean scar pregnancy, angular pregnancies, or a cervical pregnancy; 2. patients who underwent other intrauterine surgical procedures, such as endometrial polypectomy, submucosal myomectomy, or uterine septum resection, during hysteroscopy; 3. patients who underwent medical termination of pregnancy with oral mifepristone plus misoprostol without surgery; 4. patients with abnormal postoperative pathological results, e.g., molar pregnancy; 5. patients without follow-up data or ultrasound results or with incomplete data for 3 months after surgery; 6. patients whose initial surgery was not performed at the study hospital.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07883057). StuddyBuddy aggregates publicly available trial information.