NCT05085067

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 8, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 20, 2021

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2022

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2025

Completed
Last Updated

March 12, 2025

Status Verified

March 1, 2025

Enrollment Period

3.1 years

First QC Date

October 8, 2021

Last Update Submit

March 10, 2025

Conditions

Retained Products of Conception

Keywords

Retained Products of ConceptionHysteroscopyIntrauterine adhesionAuto-crossed-linked hyaluronic acid gel

Outcome Measures

Primary Outcomes (4)

  • 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.

  • 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.

  • Concentration of the menstrual pattern

    at 3 months after the initial surgery

  • Pregnancy rate

    at 12-month after the initial surgery

Secondary Outcomes (1)

  • Rate of complications

    up to 12 weeks

Study Arms (2)

Group A: no auto-cross linked hyaluronic acid gel

NO INTERVENTION

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

Group B: infusing auto-cross linked hyaluronic acid gel

EXPERIMENTAL

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

Other: auto-crossed-linked hyaluronic acid gel

Interventions

auto-crossed-linked hyaluronic acid gelOTHER

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

Group B: infusing auto-cross linked hyaluronic acid gel

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Clinical diagnosis of retained products of conception
  • Written consent obtained

You may not qualify if:

  • Patients with severe complications of medicine and surgery
  • Acute or chronic genital tract inflammation
  • No understanding or approving the randomized controlled trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

FuxingHospital，Captital Medical University

Beijing, Beijing Municipality, 100038, China

RECRUITING

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

Genital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Diseases

Central Study Contacts

Xue Yang, Master

CONTACT

8618810957056yuanxy515@163.com

Rong Li Huo, Doctor

CONTACT

8601088062032fxyykjc2014@sina.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

October 8, 2021

First Posted

October 20, 2021

Study Start

April 1, 2022

Primary Completion

April 30, 2025

Study Completion

May 30, 2025

Last Updated

March 12, 2025

Record last verified: 2025-03

Locations

CN(1)