Effectiveness of Hyaluronic Acid Gel in the Prevention of Intrauterine Adhesions After Second Trimester Abortion

Istanbul University

Status and phase: Unknown; Phase 4

Conditions: Placenta Retained; Uterine Diseases

Treatments: Device: intrauterine self-cross-linked hyaluronic acid gel

Study type: Interventional

Funder types: Other

Identifiers

NCT02868437

ODural

Details and patient eligibility

About

This prospective, randomized, controlled study evaluates the efficacy of self-crosslinked hyaluronic acid gel to prevent the development of de-novo intrauterine adhesions following curettage for retained product after second trimester abortion. One group of participants will underwent curettage plus intrauterine application of self-crosslinked hyaluronic acid gel while the other group will underwent curettage alone (control group).

Full description

Intrauterine adhesions are the major long-term complication of curettage for retained products of conception. The risk of adhesion is higher after second trimester abortion. This complication may result in infertility, recurrent miscarriages and irregular periods with dysmenorrhea and pelvic pain.

They have been reported that the intrauterine application of auto-crosslinked hyaluronic acid gel following hysteroscopic adhesiolysis or hysteroscopic surgery significantly reduces the formation of post-operative intrauterine adhesions.

The aim of this prospective, randomized, controlled study is to evaluate the efficacy of self-crosslinked hyaluronic acid gel in the reduction of development of de-novo post-curettage adhesions at 2 months follow-up.

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject has curettage for retained product after second trimester abortion

Exclusion criteria

• History of curettage or other intrauterine surgery
• History of post-abortion complication or infection

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Group 1

Active Comparator group

Description:

The patients who are having curettage for retained product after second trimester abortion will also receive an intervention of intrauterine self-cross-linked hyaluronic acid gel after the procedure

Treatment:

Device: intrauterine self-cross-linked hyaluronic acid gel

Group 2

No Intervention group

Description:

The patients who are having curettage for retained product after second trimester abortion will receive no intervention