Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion

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

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.

Study Overview

• Status: Completed
• Conditions: Hysteroscopy; Intrauterine Adhesion
• Intervention / Treatment: Procedure: Hysteroscopy

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Kaohsiung, Taiwan, 123
    • Chang Gung Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 41 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Procedure: Hysteroscopy; outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).
No Intervention: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of intrauterine adhesions	assess with hysteroscopy	6 months later after induced abortion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Menstrual cycle condition: Menstrual duration	days: by questionnaire	6 months later after induced abortion
Menstrual cycle condition: Menstrual symptoms	dysmenorrhea/no dysmenorrhea: by questionnaire	6 months later after induced abortion
Sonography findings:endometrial thickness	centimeters	6 months later after induced abortion
Sonography findings: morphology	Normal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line)	6 months later after induced abortion
Fertility outcome	Pregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth	2 years later after induced abortion

Collaborators and Investigators

• Sponsor: Chang Gung Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2019
• Primary Completion (Actual): April 30, 2022
• Study Completion (Actual): April 30, 2022

Study Registration Dates

• First Submitted: November 10, 2019
• First Submitted That Met QC Criteria: November 14, 2019
• First Posted (Actual): November 18, 2019

Study Record Updates

• Last Update Posted (Actual): July 22, 2022
• Last Update Submitted That Met QC Criteria: July 21, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Hysteroscopy; Induced abortion; Uterine adhesions; Reproductive infertility
• Additional Relevant MeSH Terms: Pathologic Processes; Fibrosis; Cicatrix; Tissue Adhesions
• Other Study ID Numbers: CMRPG8J1131

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No