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Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion

Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion: a Randomized Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04166500
Enrollment
70
Registered
2019-11-18
Start date
2019-11-01
Completion date
2022-04-30
Last updated
2022-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysteroscopy, Intrauterine Adhesion

Keywords

Induced abortion, Uterine adhesions, Reproductive infertility, Hysteroscopy

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.

Interventions

PROCEDUREHysteroscopy

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

Sponsors

Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Incidence rate of intrauterine adhesions6 months later after induced abortionassess with hysteroscopy

Secondary

MeasureTime frameDescription
Menstrual cycle condition: Menstrual amount6 months later after induced abortionNormal/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 duration6 months later after induced abortiondays: by questionnaire
Menstrual cycle condition: Menstrual symptoms6 months later after induced abortiondysmenorrhea/no dysmenorrhea: by questionnaire
The American Fertility Society (AFS) intrauterine adhesion (IUA) score6 months later after induced abortionAssess 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).
Sonography findings: morphology6 months later after induced abortionNormal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line)
Fertility outcome2 years later after induced abortionPregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth
Sonography findings:endometrial thickness6 months later after induced abortioncentimeters

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 6, 2026