Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04166500|
Recruitment Status : Recruiting
First Posted : November 18, 2019
Last Update Posted : December 5, 2019
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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
outpatient hysteroscopy after the first menstrual cycle in the follicular phase (9-12 days).
|No Intervention: Control|
- Incidence rate of intrauterine adhesions [ Time Frame: 6 months later after induced abortion ]assess with hysteroscopy
- 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).
- 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.
- Menstrual cycle condition: Menstrual duration [ Time Frame: 6 months later after induced abortion ]days: by questionnaire
- Menstrual cycle condition: Menstrual symptoms [ Time Frame: 6 months later after induced abortion ]dysmenorrhea/no dysmenorrhea: by questionnaire
- Sonography findings:endometrial thickness [ Time Frame: 6 months later after induced abortion ]centimeters
- Sonography findings: morphology [ Time Frame: 6 months later after induced abortion ]Normal. Abnormal (hyperechogenic lesion/hypoechogenic lesion/other irregular endometrial line)
- Fertility outcome [ Time Frame: 2 years later after induced abortion ]Pregnancy outcome: no pregnancy/ abortion/ gestational age/ live birth
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
|Contact: Kuo-Chung Lan, PhDemail@example.com|
|Contact: Ni-Chin Tsai, MDfirstname.lastname@example.org|