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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Wenzhou Medical University
- Enrollment
- 171
- Locations
- 1
- Primary Endpoint
- the AFS Score at Second-look Hysteroscopy
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Intrauterine balloon (Device)
intrauterine 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.
Intervention: Intrauterine Contraceptive Device Plus Foley Catheter (Device)
Outcomes
Primary Outcomes
the AFS Score at Second-look Hysteroscopy
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Feng Lin
attending doctor
Wenzhou Medical University