Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

Wenzhou Medical University

Status: Completed

Conditions: Asherman Syndrome

Treatments: Device: Intrauterine Contraceptive Device Plus Foley Catheter; Device: Intrauterine balloon

Study type: Interventional

Funder types: Other

Identifiers

NCT02867202

Wenzhou MC

Details and patient eligibility

About

This study was taken out to compare two mechanical devices (intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter) in the therapy for intrauterine adhesions after hysteroscopic adhesiolysis. Participates were assigned into two groups by randomly.

Full description

Intrauterine balloon and Intrauterine Contraceptive Device Plus Foley Catheter are both effective in the therapy for intrauterine adhesion.

The Intrauterine Contraceptive Device Plus Foley Catheter are usually inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed two or three month later.

The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus, and usually removed on the 7th day after surgery.

Enrollment: 171 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Moderate to severe intrauterine adhesion (AFS score ≥5）
• Agreement to have a second-look hysteroscopy
• no previous history of hysteroscopic adhesiolysis

Exclusion criteria

• Minimal adhesion (AFS score<5)
• Previous hysteroscopic adhesiolysis

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

171 participants in 2 patient groups

Intrauterine balloon

Experimental group

Description:

The heart-shaped intrauterine balloon is designed to fit into the cavity of the uterus,and removed on the 7th day after surgery. And hysteroscopy was taken out again after two or three months to re-evaluate the uterine adhesions.

Treatment:

Device: Intrauterine balloon

intrauterine device Plus Foley Catheter

Experimental group

Description:

Intrauterine Contraceptive Device Plus Foley Catheter are inserted into the uterine after hysteroscopic adhesiolysis. Foley Catheter is removed after three days while intrauterine device is removed at the second hysteroscopy. Uterine adhesions are judged again at the second hysteroscopy.

Treatment:

Device: Intrauterine Contraceptive Device Plus Foley Catheter