Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion

NCT ID: NCT04166500

Last Updated: 2022-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2022-04-30

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.

Conditions

Hysteroscopy; Intrauterine Adhesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

Group Type: EXPERIMENTAL

Hysteroscopy

Intervention Type: PROCEDURE

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

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Hysteroscopy

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

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Chang Gung Memorial Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Countries

Taiwan

References

Tsai NC, Hsiao YY, Su YT, Lin YJ, Kung FT, Chen PH, Lan KC. The efficacy of early office hysteroscopy in preventing intrauterine adhesions after abortion: a randomized controlled trial. BMC Womens Health. 2024 Jul 13;24(1):400. doi: 10.1186/s12905-024-03247-0.

Reference Type: DERIVED

PMID: 39003483 (View on PubMed)

Other Identifiers

CMRPG8J1131

Identifier Type: -

Identifier Source: org_study_id