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Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion

Primary Purpose

Hysteroscopy, Intrauterine Adhesion

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Hysteroscopy
Sponsored by
Chang Gung Memorial Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hysteroscopy focused on measuring Induced abortion, Uterine adhesions, Reproductive infertility, Hysteroscopy

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Chang Gung Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Outcomes

Primary Outcome Measures

Incidence rate of intrauterine adhesions
assess with hysteroscopy

Secondary Outcome Measures

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).
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.
Menstrual cycle condition: Menstrual duration
days: by questionnaire
Menstrual cycle condition: Menstrual symptoms
dysmenorrhea/no dysmenorrhea: by questionnaire
Sonography findings:endometrial thickness
centimeters
Sonography findings: morphology
Normal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line)
Fertility outcome
Pregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth

Full Information

First Posted
November 10, 2019
Last Updated
July 21, 2022
Sponsor
Chang Gung Memorial Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04166500
Brief Title
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

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 30, 2022 (Actual)
Study Completion Date
April 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chang Gung Memorial Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hysteroscopy, Intrauterine Adhesion
Keywords
Induced abortion, Uterine adhesions, Reproductive infertility, Hysteroscopy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Hysteroscopy
Intervention Description
outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).
Primary Outcome Measure Information:
Title
Incidence rate of intrauterine adhesions
Description
assess with hysteroscopy
Time Frame
6 months later after induced abortion
Secondary Outcome Measure Information:
Title
The American Fertility Society (AFS) intrauterine adhesion (IUA) score
Description
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).
Time Frame
6 months later after induced abortion
Title
Menstrual cycle condition: Menstrual amount
Description
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.
Time Frame
6 months later after induced abortion
Title
Menstrual cycle condition: Menstrual duration
Description
days: by questionnaire
Time Frame
6 months later after induced abortion
Title
Menstrual cycle condition: Menstrual symptoms
Description
dysmenorrhea/no dysmenorrhea: by questionnaire
Time Frame
6 months later after induced abortion
Title
Sonography findings:endometrial thickness
Description
centimeters
Time Frame
6 months later after induced abortion
Title
Sonography findings: morphology
Description
Normal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line)
Time Frame
6 months later after induced abortion
Title
Fertility outcome
Description
Pregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth
Time Frame
2 years later after induced abortion

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Chang Gung Memorial Hospital
City
Kaohsiung
ZIP/Postal Code
123
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion

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