N/A
Completed N=200
Postoperative Intermittent Intrauterine Balloon Dilatation Therapy.
Source: ClinicalTrials.gov NCT03131596 ↗Enrolled (actual)
200
Serious AEs
0.0%
Results posted
Sep 2019
Primary outcomePrimary: Number of Participants With Adhesion Reformation (American Fertility Society Score of Greater Than 0) 8 Weeks Later After the Index Surgery — 21; 38 Participants — p=0.012
Summary
In this prospective, randomized, controlled study, the investigators wish to determine the efficacy of intrauterine balloon (IUB) dilatation in the prevention of adhesion reformation when compared with the conventional management.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Adhesion Reformation (American Fertility Society Score of Greater Than 0) 8 Weeks Later After the Index Surgery |
21; 38 | 0.012 sig |
| PRIMARY The American Fertility Society Score 8 Weeks After Operation |
0; 2 | <0.001 sig |
| PRIMARY Pictorial Blood Loss Assessment Chart Score 8 Weeks After Operation |
51.3; 31.6 | <0.001 sig |
| SECONDARY Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy |
27; 26; 18; 16; 8; 9 | >0.05 |
Eligibility Criteria
Inclusion Criteria
- women aged 18-40 years;
- moderate to severe intrauterine adhesion (AFS score≥5);
- no previous history of hysteroscopic adhesiolysis in our hospital;
- written consent obtained
- agreement to have second-look and third-look hysteroscopy.
Exclusion Criteria
- minimal adhesion (AFS score <5);
- previous hysteroscopic adhesiolysis in our hospital.
Data sourced from ClinicalTrials.gov (NCT03131596). 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. Informational only — not medical advice.