Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion

Hysteroscopy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04166500
• Other study ID #: CMRPG8J1131
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Hysteroscopy
• Intrauterine Adhesion
• Tissue Adhesions

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