Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion: a Randomized Controlled Trial
Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion
Sponsors
Source
Chang Gung Memorial Hospital
Oversight Info
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
Brief Summary
Background: Intrauterine adhesions are a difficult clinical problem for reproductive
infertility. The most common cause is uterine cavity surgery and post-abortion (including
abortion and spontaneous abortion). After the abortion, the uterine cavity adhesion, when is
the key point, the literature is not much ink, early literature has mentioned that after the
abortion, the uterus scraping action is scraped in four days and the uterine adhesion will be
smaller than one to four weeks. Much more, it seems that the sooner the uterine adhesion
factor is excluded, the more it can reduce uterine adhesion, but the uterine curettage itself
is a risk factor for uterine adhesion. This early practice, the current clinical application,
is not used, Instead, it is a hysteroscopy. Our past clinical observations, as soon as
possible after the abortion, outpatient hysteroscopy, can find the tissue factors that may
cause adhesion in the uterine cavity as soon as possible, and immediately remove it with an
outpatient hysteroscope.
Objective: To verify the early outpatient hysteroscopy and reduce the occurrence of
intrauterine adhesion after abortion.
Expected benefits to patients: Abortion is likely to cause intrauterine adhesions, which may
further cause the incidence of reproductive infertility, should be involved before the
formation of permanent injury, reduce the adhesion of the uterine cavity. Outpatient
hysteroscopy is a simple and easy-to-use examination procedure that is painless and does not
require anesthesia. Although it is invasive but has few complications, it is expected to
reduce the occurrence of intrauterine adhesion after abortion.
Overall Status
Recruiting
Start Date
2019-12-02
Completion Date
2022-03-30
Primary Completion Date
2021-09-30
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Incidence rate of intrauterine adhesions |
6 months later after induced abortion |
Secondary Outcome
Measure |
Time Frame |
|
The American Fertility Society (AFS) intrauterine adhesion (IUA) score |
6 months later after induced abortion |
|
Menstrual cycle condition: Menstrual amount |
6 months later after induced abortion |
|
Menstrual cycle condition: Menstrual duration |
6 months later after induced abortion |
|
Menstrual cycle condition: Menstrual symptoms |
6 months later after induced abortion |
|
Sonography findings:endometrial thickness |
6 months later after induced abortion |
|
Sonography findings: morphology |
6 months later after induced abortion |
|
Fertility outcome |
2 years later after induced abortion |
Enrollment
150
Conditions
Intervention
Intervention Type
Procedure
Intervention Name
Description
outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).
Arm Group Label
Intervention
Eligibility
Criteria
Inclusion Criteria:
- female age 20 to 45 years-old
- undergo induced abortion
- desire future fertility
- agree with the trial and sign the consent form
Exclusion Criteria:
- previous intrauterine surgery
- previous intrauterine adhesion
- previous having over(and/or equal to) 3 times of induced abortion
- infection condition
Gender
Female
Minimum Age
20 Years
Maximum Age
45 Years
Healthy Volunteers
Accepts Healthy Volunteers
Overall Contact
Location
Facility |
Status |
Contact |
|
Chang Gung Memorial Hospital Kaohsiung 123 Taiwan |
Recruiting |
Location Countries
Country
Taiwan
Verification Date
2019-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Sponsor
Keywords
Has Expanded Access
No
Condition Browse
Number Of Arms
2
Arm Group
Arm Group Label
Intervention
Arm Group Type
Experimental
Arm Group Label
Control
Arm Group Type
No Intervention
Firstreceived Results Date
N/A
Overall Contact Backup
Patient Data
Sharing Ipd
Undecided
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Study First Submitted
November 10, 2019
Study First Submitted Qc
November 14, 2019
Study First Posted
November 18, 2019
Last Update Submitted
December 4, 2019
Last Update Submitted Qc
December 4, 2019
Last Update Posted
December 5, 2019
ClinicalTrials.gov processed this data on December 13, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.