CompletedNot Applicable

Postoperative Intermittent Intrauterine Balloon Dilatation Therapy.

China200 participantsStarted 2017-05-15

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexFEMALE

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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.

What they're measuring

Number of Participants With Adhesion Reformation (American Fertility Society Score of Greater Than 0) 8 Weeks Later After the Index Surgery

Timeframe: at 8 weeks post-operation

The American Fertility Society Score 8 Weeks After Operation

Timeframe: at 8 weeks post-operation

Pictorial Blood Loss Assessment Chart Score 8 Weeks After Operation

Timeframe: at 8 weeks post-operation

Trial details

NCT IDNCT03131596

SponsorFu Xing Hospital, Capital Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-11-15

Results submitted2018-11-22

View on ClinicalTrials.gov More Intrauterine Adhesion trials