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Randomized controlled trial of self-cross-linking sodium hyaluronate gel to prevent recurrence after intrauterine adhesions separation

Randomized controlled trial of self-cross-linking sodium hyaluronate gel to prevent recurrence after intrauterine adhesions separation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200056807
Enrollment
Unknown
Registered
2022-02-17
Start date
2022-02-08
Completion date
Unknown
Last updated
2023-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intrauterine Adhesion

Interventions

control group:The uterine balloon stent was removed 5-7 days after surgery
treatment group 1:The uterine balloon stent was removed 5-7 days after surgery and ACP gel was placed in the uterine cavity again
treatment group 2:The uterine balloon stent was removed 5-7 days after surgery, and ACP gel was placed again in the uterine cavity after hysteroscopy 4 weeks later
treatment group 3:ACP gel was placed in the uterine cavity again 5-7 days after the removal of the uterine balloon stent, and ACP gel was placed in the uterine cavity for the third time 4 weeks after

Sponsors

Fuxing Hospital, Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
20 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1. Women aged 20-40 years; 2. Suffering from intrauterine adhesions (AFS score 1-12); 3. Weight 50-80kg; 4. Obtain written consent; 5. The patient agreed to undergo transvaginal ultrasonography and hysteroscopy second and third probe (the first and second hysteroscopy) at 4 weeks and 8 weeks after surgery, respectively, and a little endometrium was removed for immunohistochemistry after hysteroscopy second probe; 6. Patients were followed up by telephone 3 months after surgery for menstrual improvement.

Exclusion criteria

Exclusion criteria: 1. History of uterine artery embolization; 2. Only cervical intraoral adhesion; 3. Hormone replacement therapy within 3 months; 4. Patients with serious internal and surgical complications; 5. Pregnancy status; 6. Preoperative fever or infection symptoms; 7. Malignant tumor; 8. Patients with history of pelvic inflammatory disease; 9. The diameter of uterine fibroids is greater than 3cm; 10. Adenomyosis; 11. Patients with contraindication to anesthesia; 12. Those who do not understand or agree with randomized controlled trials.

Design outcomes

Primary

MeasureTime frame
recurrence rate of intrauterine adhesion;severity of reformed adhesion;post-operative menstrual score;

Countries

China

Contacts

Public ContactLi Tianzhao, Xiao Yu
729995176@qq.com+86 18601262217

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026