CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 200 enrolled
Drug / intervention
IUB dilatation therapyprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03131596
NCT03131596N/ACompleted
CompareCT.gov

Prevention of Postoperative Adhesion Reformation by Intrauterine Balloon Therapy: a Randomized Controlled Trial

Fu Xing Hospital, Capital Medical University·interventional·Posted Apr 27, 2017·Updated Sep 13, 2019

In Brief

A clinical study evaluating IUB dilatation therapy for Intrauterine Adhesion. Completed, enrolled 200 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIntrauterine Adhesion
CountriesChina
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedApr 27, 2017
Enrollment StartMay 15, 2017
Primary CompletionNov 15, 2017
Study CompletionNov 15, 2018
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 9.2 years ago

Interventions

IUB dilatation therapyprocedure

A Foley catheter (size 14fr) will be prepared by cutting the excess catheter tip protruding beyond the balloon prior to insertion into the uterine cavity. Once the catheter has reached the fundus, 3-4.5mls of saline will be slowly introduced into the balloon under ultrasound guidance, in order to directly visualize the distention of the cavity and division of any intrauterine adhesions, if present.