The Efficacy of Auto-cross Linked Hyaluronic Acid Gel in the Prevention of Adhesion Reformation After Hysteroscopic Resection of Retained Products of Conception

Retained Products of Conception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05085067
• Other study ID #: FXHV1.0-2020-11-15
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: January 21, 2025

Study information

• Verified date: February 2024
• Source: Fu Xing Hospital, Capital Medical University
• Contact: Xue Yang, Master
• Phone: 8618810957056
• Email: yuanxy515[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Retained product of conception (RPOC) is defined by abnormal trophoblastic persistence or retained placenta inside the uterus cavity after a pregnancy independently of the outcome. Untreated RPOC can compromise future fertility. RPOC are generally treated surgically, either by repeated evacuation or by hysteroscopy, which exposes the uterus to additional potential trauma.The combination of trauma to the gravid uterine cavity, hypoestrogenic state at the time of the operation or immediately afterward and local infection is considered to be the pathogenic mechanism of intrauterine adhesions (IUA) , manifested clinically by menstrual abnormalities, infertility and recurrent pregnancy loss.To investigate the efficacy of auto-cross linked hyaluronic acid gel in the prevention of adhesion reformation after hysteroscopic resection of retained products of conception.

After the completion of hysteroscopic resection of retained products of conception, patients will be randomized to one of the two groups by computer-generated numbers: [1] infusing auto-cross linked hyaluronic acid gel into intrauterine cavity in the experimental group; [2] no auto-cross linked hyaluronic acid gel into intrauterine cavity in the control group. Second and third look outpatient hysteroscopy will be performed 4 and 8 weeks after the initial surgery. The patients will be followed up about menstrual pattern at 3 months after the surgery.The patients will be followed up about pregancy outcome at 12 months after the surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: January 21, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Clinical diagnosis of retained products of conception

• Written consent obtained

Exclusion Criteria:

• Patients with severe complications of medicine and surgery

• Acute or chronic genital tract inflammation

• No understanding or approving the randomized controlled trial

Related Conditions & MeSH terms

• Retained Products of Conception
• Tissue Adhesions

Intervention

Other:
• auto-crossed-linked hyaluronic acid gel
infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception

Locations

Country	Name	City	State
China	FuxingHospital,Captital Medical University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Fu Xing Hospital, Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adhesion reformation rate at third-look hysteroscopy		A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
Primary	Adhesion score at third-look hysteroscopy		A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
Primary	Concentration of the menstrual pattern		at 3 months after the initial surgery
Primary	Pregnancy rate		at 12-month after the initial surgery
Secondary	Rate of complications		up to 12 weeks