Adjuvant Therapy for Intrauterine Adhesions Between Two Groups

Not Applicable

Completed

• Conditions: Asherman Syndrome
• Interventions: Device: Intrauterine balloon; Device: Intrauterine Contraceptive Device Plus Foley Catheter

• Registration Number: NCT02867202
• Lead Sponsor: Wenzhou Medical University

Brief 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.

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2016-04-11
• Study First Submitted QC: 2016-08-10
• Study First Posted: 2016-08-15
• Primary Completion: 2017-12
• Study Completion: 2017-12
• Results First Submitted: 2017-12-27
• Status Verified: 2019-12
• Results First Submitted QC: 2019-12-15
• Last Update Submitted: 2019-12-15
• Results First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 171

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intrauterine balloon	Intrauterine balloon	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.
intrauterine device Plus Foley Catheter	Intrauterine Contraceptive Device Plus Foley Catheter	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.

Primary Outcome Measures

Name	Time	Method
the AFS Score at Second-look Hysteroscopy	2 or 3 months after the surgery	The AFS score is based on the American Fertility Society (AFS) Classification of Intra-uterine adhesions( 1988 version)The total range of AFS score is from 0 to 12, and the higher the score is, the worse the outcome is.

Trial Locations

Locations (1)

the 1st Affiliated Hospital of Wenzhou Medical University; 🇨🇳 Wenzhou, Zhejiang, China