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

Primary Purpose

Retained Products of Conception

Status
Active
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
auto-crossed-linked hyaluronic acid gel
Sponsored by
Fu Xing Hospital, Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Retained Products of Conception focused on measuring Retained Products of Conception, Hysteroscopy, Intrauterine adhesion, Auto-crossed-linked hyaluronic acid gel

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • FuxingHospital，Captital Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Group A: no auto-cross linked hyaluronic acid gel

Group B: infusing auto-cross linked hyaluronic acid gel

Arm Description

no auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception

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

Outcomes

Primary Outcome Measures

Adhesion reformation rate at third-look hysteroscopy
Adhesion score at third-look hysteroscopy
Concentration of the menstrual pattern
Pregnancy rate

Secondary Outcome Measures

Rate of complications

Full Information

First Posted
October 8, 2021
Last Updated
September 17, 2023
Sponsor
Fu Xing Hospital, Capital Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05085067
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
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
January 21, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fu Xing Hospital, Capital Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Retained Products of Conception
Keywords
Retained Products of Conception, Hysteroscopy, Intrauterine adhesion, Auto-crossed-linked hyaluronic acid gel

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
86 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A: no auto-cross linked hyaluronic acid gel
Arm Type
No Intervention
Arm Description
no auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception
Arm Title
Group B: infusing auto-cross linked hyaluronic acid gel
Arm Type
Experimental
Arm Description
infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception
Intervention Type
Other
Intervention Name(s)
auto-crossed-linked hyaluronic acid gel
Intervention Description
infusing auto-cross linked hyaluronic acid gel into intrauterine cavity after hysteroscopic treatment because of retained products of conception
Primary Outcome Measure Information:
Title
Adhesion reformation rate at third-look hysteroscopy
Time Frame
A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
Title
Adhesion score at third-look hysteroscopy
Time Frame
A third-look hysteroscopy will be carried out 8 weeks after the initial operation.Findings are graded according to the American Fertility Society classification.
Title
Concentration of the menstrual pattern
Time Frame
at 3 months after the initial surgery
Title
Pregnancy rate
Time Frame
at 12-month after the initial surgery
Secondary Outcome Measure Information:
Title
Rate of complications
Time Frame
up to 12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
FuxingHospital，Captital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100038
Country
China

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

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

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