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

NCT ID: NCT05085067

Last Updated: 2025-03-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-05-30

Brief Summary

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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.

Detailed Description

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Conditions

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Retained Products of Conception

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Group A: no auto-cross linked hyaluronic acid gel

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Group B: infusing auto-cross linked hyaluronic acid gel

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

Group Type EXPERIMENTAL

auto-crossed-linked hyaluronic acid gel

Intervention Type OTHER

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

Interventions

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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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Fu Xing Hospital, Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Yang Xue

principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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FuxingHospital,Captital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xue Yang, Master

Role: CONTACT

8618810957056

Rong Li Huo, Doctor

Role: CONTACT

8601088062032

Facility Contacts

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Xue Yang, Master

Role: primary

+8618810957056

Rong L Huo, Doctor

Role: backup

+861088062032

Other Identifiers

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FXHV1.0-2020-11-15

Identifier Type: -

Identifier Source: org_study_id

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