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Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion

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ClinicalTrials.gov Identifier: NCT04166500
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : December 5, 2019
Sponsor:
Information provided by (Responsible Party):
Chang Gung Memorial Hospital

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.


Condition or disease Intervention/treatment Phase
Hysteroscopy Intrauterine Adhesion Procedure: Hysteroscopy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion: a Randomized Controlled Trial
Actual Study Start Date : December 2, 2019
Estimated Primary Completion Date : September 30, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Adhesions

Arm Intervention/treatment
Experimental: Intervention Procedure: Hysteroscopy
outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).

No Intervention: Control



Primary Outcome Measures :
  1. Incidence rate of intrauterine adhesions [ Time Frame: 6 months later after induced abortion ]
    assess with hysteroscopy


Secondary Outcome Measures :
  1. The American Fertility Society (AFS) intrauterine adhesion (IUA) score [ Time Frame: 6 months later after induced abortion ]
    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).

  2. Menstrual cycle condition: Menstrual amount [ Time Frame: 6 months later after induced abortion ]

    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.


  3. Menstrual cycle condition: Menstrual duration [ Time Frame: 6 months later after induced abortion ]
    days: by questionnaire

  4. Menstrual cycle condition: Menstrual symptoms [ Time Frame: 6 months later after induced abortion ]
    dysmenorrhea/no dysmenorrhea: by questionnaire

  5. Sonography findings:endometrial thickness [ Time Frame: 6 months later after induced abortion ]
    centimeters

  6. Sonography findings: morphology [ Time Frame: 6 months later after induced abortion ]
    Normal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line)

  7. Fertility outcome [ Time Frame: 2 years later after induced abortion ]
    Pregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth



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Ages Eligible for Study:   20 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04166500


Contacts
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Contact: Kuo-Chung Lan, PhD +886-975056415 lankuochung@gmail.com
Contact: Ni-Chin Tsai, MD +886-975368271 ninytsai@gmail.com

Locations
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Taiwan
Chang Gung Memorial Hospital Recruiting
Kaohsiung, Taiwan, 123
Contact: Kuo-Chung Lan, PhD    +886-975056415    lankuochung@gmail.com   
Contact: Ni-Chin Tsai, MD    +886-975369271    ninytsai@gmail.com   
Sponsors and Collaborators
Chang Gung Memorial Hospital

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Responsible Party: Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier: NCT04166500     History of Changes
Other Study ID Numbers: CMRPG8J1131
First Posted: November 18, 2019    Key Record Dates
Last Update Posted: December 5, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chang Gung Memorial Hospital:
Induced abortion
Uterine adhesions
Reproductive infertility
Hysteroscopy
Additional relevant MeSH terms:
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Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes