NCT02867202

Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

A Randomized Clinical Trial to Assess the Efficacy of Intrauterine Balloon Compared to Intrauterine Contraceptive Device Plus Foley Catheter in the Therapy for Uterine Adhesion After Hysteroscopic Adhesiolysis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 171 (actual)
• Sponsor: Wenzhou Medical University · Academic / Other
• Sex: Female
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Asherman Syndrome

Interventions

Type	Name	Description
DEVICE	Intrauterine balloon	After the completion of hysteroscopic adhesiolysis, intrauterine balloon was inserted and inflated with 3-5 mL normal saline which was removed after 1 week.
DEVICE	Intrauterine Contraceptive Device Plus Foley Catheter	After the completion of hysteroscopic adhesiolysis, Intrauterine Contraceptive Device Plus Foley Catheter were inserted into the uterine cavity. Foley Catheter was removed after three days and Intrauterine Device was removed at the second time of hysteroscopy.

Timeline

• Start date: 2015-06-01
• Primary completion: 2017-12-01
• Completion: 2017-12-01
• First posted: 2016-08-15
• Last updated: 2020-01-02
• Results posted: 2020-01-02

Locations

1 site across 1 country: China