NCT03353909

Brief Summary

Using American Fertility Society classification of intrauterine adhesions, the efficacy of a new crosslinked hyaluronan gel in reducing intrauterine adhesion formation after dilatation and curettage for delayed miscarriage in women without previous dilatation and curettage was examined.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2016

Shorter than P25 for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2017

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

October 10, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 27, 2017

Completed
Last Updated

November 27, 2017

Status Verified

November 1, 2017

Enrollment Period

8 months

First QC Date

October 10, 2017

Last Update Submit

November 23, 2017

Conditions

Intrauterine Adhesion

Keywords

Intrauterine adhesionDelayed miscarriagehyaluronan gel

Outcome Measures

Primary Outcomes (1)

  • Incidence of intrauterine adhesion

    The number of women with intrauterine adhesion

    3 months after dilatation and curettage

Secondary Outcomes (5)

  • The adhesion scores of extent of uterine cavity involved

    3 months after dilatation and curettage

  • The adhesion scores of type of adhesion

    3 months after dilatation and curettage

  • The adhesion scores of menstrual pattern

    3 months after dilatation and curettage

  • Cumulative adhesion score

    3 months after dilatation and curettage

  • Severity

    3 months after dilatation and curettage

Study Arms (2)

Treatment

EXPERIMENTAL

At the end of the dilatation and curettage, new crosslinked hyaluronan gel (3ml) was applied to the uterine cavity in women assigned to the treatment group through a 15-cm sterile cannula.

Device: new crosslinked hyaluronan gel

Control

NO INTERVENTION

At the end of the dilatation and curettage, nothing was applied to the uterine cavity in women assigned to the control group.

Interventions

new crosslinked hyaluronan gelDEVICE

At the end of the dilatation and curettage, new crosslinked hyaluronan gel was applied to the uterine cavity.

Also known as: MateRegen Gel
Treatment

Eligibility Criteria

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

You may qualify if:

  • Patients to be female, aged 18-45 years
  • Without previous dilatation and curettage
  • Undergoing dilatation and curettage for the current delayed miscarriage
  • All participants should be with normal liver/rental function and without systemic disease
  • Agree to use adequate forms of contraception throughout the study
  • Be in good compliance with the follow-up examination according to the study protocol.

You may not qualify if:

  • Known/suspected intolerance or hypersensitivity to hyaluronan or its derivatives
  • Genital tract malformation
  • Inflammation of genital tract or pelvic cavity, clinical evidence of cancer in genital tract
  • Suspected genital tuberculosis
  • Abnormal blood coagulation
  • Medical histories of peripheral vascular disease, alcohol/drug abuse, and mental illness
  • Acute or severe infection
  • Autoimmune diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Li X, Wu L, Zhou Y, Fan X, Huang J, Wu J, Yu R, Lou J, Yang M, Yao Z, Xue M. New Crosslinked Hyaluronan Gel for the Prevention of Intrauterine Adhesions after Dilation and Curettage in Patients with Delayed Miscarriage: A Prospective, Multicenter, Randomized, Controlled Trial. J Minim Invasive Gynecol. 2019 Jan;26(1):94-99. doi: 10.1016/j.jmig.2018.03.032. Epub 2018 Apr 17.

    PMID: 29678756DERIVED

MeSH Terms

Conditions

Gynatresia

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 10, 2017

First Posted

November 27, 2017

Study Start

July 1, 2016

Primary Completion

February 15, 2017

Study Completion

February 15, 2017

Last Updated

November 27, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share