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Postoperative Intermittent Intrauterine Balloon Dilatation Therapy.

NCT03131596 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2019-09-13

Study results available
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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.

Conditions

  • Intrauterine Adhesion

Interventions

PROCEDURE

IUB dilatation therapy

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.

Sponsors & Collaborators

  • Fu Xing Hospital, Capital Medical University

    lead OTHER

Principal Investigators

  • Tinchiu Li · Fuxing Hospital,Capital Medical University，China

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-15
Primary Completion
2017-11-15
Completion
2018-11-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03131596 on ClinicalTrials.gov