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Completed

NCT Number: NCT04166500

Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion

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.

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Key information

Age range

20 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Chang Gung Memorial Hospital

Kaohsiung City, 123, Taiwan

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hysteroscopy

Procedure

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

Primary outcomes

  1. Incidence rate of intrauterine adhesions

    Time frame: 6 months later after induced abortion

    assess with hysteroscopy

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Chang Gung Memorial Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Nov 18, 2019
Registry last updated
Jul 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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