Hysteroscopy Clinical Trial
Official title:
Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion: a Randomized Controlled Trial
Verified date | July 2022 |
Source | Chang Gung Memorial Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 70 |
Est. completion date | April 30, 2022 |
Est. primary completion date | April 30, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 20 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Taiwan | Chang Gung Memorial Hospital | Kaohsiung |
Lead Sponsor | Collaborator |
---|---|
Chang Gung Memorial Hospital |
Taiwan,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence rate of intrauterine adhesions | assess with hysteroscopy | 6 months later after induced abortion | |
Secondary | 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). | 6 months later after induced abortion | |
Secondary | 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. |
6 months later after induced abortion | |
Secondary | Menstrual cycle condition: Menstrual duration | days: by questionnaire | 6 months later after induced abortion | |
Secondary | Menstrual cycle condition: Menstrual symptoms | dysmenorrhea/no dysmenorrhea: by questionnaire | 6 months later after induced abortion | |
Secondary | Sonography findings:endometrial thickness | centimeters | 6 months later after induced abortion | |
Secondary | Sonography findings: morphology | Normal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line) | 6 months later after induced abortion | |
Secondary | Fertility outcome | Pregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth | 2 years later after induced abortion |
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