Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion
Primary Purpose
Hysteroscopy, Intrauterine Adhesion
Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hysteroscopy
Sponsored by
About this trial
This is an interventional prevention trial for Hysteroscopy focused on measuring Induced abortion, Uterine adhesions, Reproductive infertility, Hysteroscopy
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
Sites / Locations
- Chang Gung Memorial Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Control
Arm Description
Outcomes
Primary Outcome Measures
Incidence rate of intrauterine adhesions
assess with hysteroscopy
Secondary Outcome Measures
The American Fertility Society (AFS) intrauterine adhesion (IUA) score
Assess by hysteroscopy and measure with IUA score. Score scaling from 1 to 12 with the higher scores mean a worse outcome. Stage I (mild, 1-4), stage II (moderate, 5-8); stage III (severe, 9-12).
Menstrual cycle condition: Menstrual amount
Normal/Hypo/Hyper by Pictorial blood loss assessment charts (PBACs): self-reported by patients and questionnaire.
Normal amount: 10 to 100 points. Hypermenorrhea: over 100 points. Hypomenorrhea: less than 10 points.
Menstrual cycle condition: Menstrual duration
days: by questionnaire
Menstrual cycle condition: Menstrual symptoms
dysmenorrhea/no dysmenorrhea: by questionnaire
Sonography findings:endometrial thickness
centimeters
Sonography findings: morphology
Normal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line)
Fertility outcome
Pregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth
Full Information
NCT ID
NCT04166500
First Posted
November 10, 2019
Last Updated
July 21, 2022
Sponsor
Chang Gung Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04166500
Brief Title
Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion
Official Title
Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion: a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopy, Intrauterine Adhesion
Keywords
Induced abortion, Uterine adhesions, Reproductive infertility, Hysteroscopy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopy
Intervention Description
outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).
Primary Outcome Measure Information:
Title
Incidence rate of intrauterine adhesions
Description
assess with hysteroscopy
Time Frame
6 months later after induced abortion
Secondary Outcome Measure Information:
Title
The American Fertility Society (AFS) intrauterine adhesion (IUA) score
Description
Assess by hysteroscopy and measure with IUA score. Score scaling from 1 to 12 with the higher scores mean a worse outcome. Stage I (mild, 1-4), stage II (moderate, 5-8); stage III (severe, 9-12).
Time Frame
6 months later after induced abortion
Title
Menstrual cycle condition: Menstrual amount
Description
Normal/Hypo/Hyper by Pictorial blood loss assessment charts (PBACs): self-reported by patients and questionnaire.
Normal amount: 10 to 100 points. Hypermenorrhea: over 100 points. Hypomenorrhea: less than 10 points.
Time Frame
6 months later after induced abortion
Title
Menstrual cycle condition: Menstrual duration
Description
days: by questionnaire
Time Frame
6 months later after induced abortion
Title
Menstrual cycle condition: Menstrual symptoms
Description
dysmenorrhea/no dysmenorrhea: by questionnaire
Time Frame
6 months later after induced abortion
Title
Sonography findings:endometrial thickness
Description
centimeters
Time Frame
6 months later after induced abortion
Title
Sonography findings: morphology
Description
Normal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line)
Time Frame
6 months later after induced abortion
Title
Fertility outcome
Description
Pregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth
Time Frame
2 years later after induced abortion
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
123
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion
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