Clinical trial NCT04166500: 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
Overall status: COMPLETED
Phase: NA
Conditions: Hysteroscopy
Intrauterine Adhesion
Keywords: Induced abortion
Uterine adhesions
Reproductive infertility
Hysteroscopy
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 70
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Incidence rate of intrauterine adhesions
timeFrame: 6 months later after induced abortion
Secondary outcomes:
measure: The American Fertility Society (AFS) intrauterine adhesion (IUA) score
timeFrame: 6 months later after induced abortion
measure: Menstrual cycle condition: Menstrual amount
timeFrame: 6 months later after induced abortion
measure: Menstrual cycle condition: Menstrual duration
timeFrame: 6 months later after induced abortion
measure: Menstrual cycle condition: Menstrual symptoms
timeFrame: 6 months later after induced abortion
measure: Sonography findings:endometrial thickness
timeFrame: 6 months later after induced abortion
measure: Sonography findings: morphology
timeFrame: 6 months later after induced abortion
measure: Fertility outcome
timeFrame: 2 years later after induced abortion
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Chang Gung Memorial Hospital
Study officials:
References: