N/A
N=171
Adjuvant Therapy for Intrauterine Adhesions Between Two Groups
Asherman Syndrome
Bottom Line
View on ClinicalTrials.gov: NCT02867202 ↗Enrolled (actual)
171
Serious AEs
0.0%
Results posted
Jan 2020
Primary outcome: Primary: the AFS Score at Second-look Hysteroscopy — 6.5; 8 Units on a scale — p=<0.05
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Intrauterine balloon (Device); Intrauterine Contraceptive Device Plus Foley Catheter (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Wenzhou Medical University
- Primary completion
- Dec 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY the AFS Score at Second-look Hysteroscopy |
6.5; 8 | <0.05 sig |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02867202). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.