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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04166500
Other study ID # CMRPG8J1131
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 1, 2019
Est. completion date April 30, 2022

Study information

Verified date July 2022
Source Chang Gung Memorial Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
Hysteroscopy
outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).

Locations

Country Name City State
Taiwan Chang Gung Memorial Hospital Kaohsiung

Sponsors (1)

Lead Sponsor Collaborator
Chang Gung Memorial Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

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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