Actively Recruiting
The Efficacy of Auto-crosslinked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception a Randomized Controlled Trial
Led by Fu Xing Hospital, Capital Medical University · Updated on 2025-03-12
86
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of auto-cross linked hyaluronic acid gel to prevent adhesion reformation after hysteroscopic surgery for retained products of conception (RPOC). RPOC occurs when placental tissue remains inside the uterus after pregnancy, which can harm future fertility. The study aims to understand if this gel can reduce the risk of intrauterine adhesions, which cause menstrual problems, infertility, and pregnancy loss. After hysteroscopic removal of RPOC, participants are randomly assigned to either receive the hyaluronic acid gel infused into the uterus or not receive the gel. Two additional outpatient hysteroscopies are done at 4 and 8 weeks after surgery to check for adhesions. The experimental group receives the gel treatment while the control group does not. Participants will report their menstrual patterns three months after surgery, and pregnancy outcomes will be followed for 12 months. The main measurements include adhesion rates and scores seen during the third-look hysteroscopy at 8 weeks. Safety is monitored for up to 12 weeks, and the study lasts over a year to track pregnancy success and menstrual changes.
CONDITIONS
Brief Title
The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of retained products of conception
- Written consent obtained
You will not qualify if you...
- Patients with severe complications of medicine and surgery
- Acute or chronic genital tract inflammation
- No understanding or approving the randomized controlled trial
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Initial operation day
Participants undergo hysteroscopic resection of retained products of conception, with some receiving an infusion of auto-cross linked hyaluronic acid gel into the intrauterine cavity after surgery.
1 surgery visit (in-person)
Duration - Up to 12 weeks for complications; adhesion and menstrual assessments at 8 weeks and 3 months; pregnancy rate assessed at 12 months.
Participants are monitored for adhesion reformation and complications after surgery, including a third-look hysteroscopy and assessment of menstrual pattern and pregnancy rate.
1 third-look hysteroscopy visit at 8 weeks; additional visits at 3 months and 12 months for assessments
Trial Site Locations
Total: 1 location
1
FuxingHospital，Captital Medical University
Beijing, Beijing Municipality, China, 100038
Actively Recruiting
Research Team
X
Xue Yang, Master
R
Rong Li Huo, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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