Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03131596
Other study ID # 2016FXHEC—KY036
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 15, 2017
Est. completion date November 15, 2018

Study information

Verified date August 2019
Source Fu Xing Hospital, Capital Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Description:

Read more »
Read more »

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Fu Xing Hospital Beijing Beijing

Sponsors (1)

Lead Sponsor Collaborator
Fu Xing Hospital, Capital Medical University

Country where clinical trial is conducted

China, 

References & Publications (9)

See more »

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Participants With Adhesion Reformation (American Fertility Society Score of Greater Than 0) 8 Weeks Later After the Index Surgery The American Fertility Society (AFS) score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score should be 0. The reformation of intrauterine adhesions was evaluated by third-look hysteroscopy, if the score was greater than 0, a adhesion reformation was considered. at 8 weeks post-operation
Primary The American Fertility Society Score 8 Weeks After Operation The American Fertility Society(AFS) score of each group was evaluated again at third-look hysteroscopy in order to reflect the efficacy of the treatment. The original AFS score was recorded in baseline characteristics part. The AFS score ranges from 0-12, while represented the severity of the adhesions. Mild 1-4, Moderate 5-8, Severe 9-12. The lower the AFS score is, the better the prognosis the patient is. When the surgery was finished the AFS score score should be 0. at 8 weeks post-operation
Primary Pictorial Blood Loss Assessment Chart Score 8 Weeks After Operation The Pictorial Blood Loss Assessment Chart (PBAC) score was used to represent the menstrual flow volume of the patient. The PBAC score was evaluated again at 8 weeks after surgery. A higher PBAC score after hysteroscopic adhesiolysis means a better outcome.The PBAC score of a normal women usually range from 30-100 points.
The minium value of PBAC score is 0, which means the patient is amenorrhea. The maximum value of PBAC score is 1000.
We measured the score before and 8 weeks after the operation in order to assess if there was any improvement (higher than before) in menstrual flow.
at 8 weeks post-operation
Secondary Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy number of patients who have pregnancy, miscarriage and ectopic pregnancy within12 months follow-up within 12 months after third look hysteroscopy(8 weeks post-operation)
See also
  Status Clinical Trial Phase
Recruiting NCT04972032 - Efficacy of Estrogen-intrauterine Stent System After Intrauterine Adhesiolysis N/A
Recruiting NCT03381807 - Human Amniotic Epithelial Stem Cell in Treatment of Refractory Severe Intrauterine Adhesion Early Phase 1
Recruiting NCT03329898 - Comparing the Efficacy of Two Methods for the Therapy of Uterine Adhesion N/A
Completed NCT03724617 - Clinical Study of Umbilical Cord Mesenchymal Stem Cells Combined With Collagen Scaffold in the Treatment of Thin Endometrium N/A
Recruiting NCT03330873 - The Efficacy and Safety of Disposable Balloon Uterine Stent in Patients With Asherman Syndrome N/A
Completed NCT02220621 - Efficacy and Safety of Crosslinked Hyaluronan Gel for Preventing Intrauterine Adhesion N/A
Active, not recruiting NCT04963179 - PREvention of Intrauterine Adhesion After Adhesiolysis With Novel Tri-block deGradable Polymer Film. N/A
Recruiting NCT03351205 - The Efficacy of Estrogen Therapy Against Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Completed NCT04381728 - PREvention of Intrauterine Adhesion After Hysteroscopic Surgery With Novel deGradable Film N/A
Recruiting NCT03346317 - Comparing the Efficacy of Two Methods in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Completed NCT05414760 - Evaluate Formation of IUAs After Third-generation Endometrial Ablation, With and Without Intrauterine Adhesion Barrier N/A
Completed NCT04166500 - Early Outpatient Hysteroscopy Can Prevent Intrauterine Adhesion After Induced Abortion N/A
Recruiting NCT03169478 - Intrauterine Balloon Dilatation Therapy in the Prevention of Adhesion Formation After Hysteroscopic Myomectomy N/A
Recruiting NCT03171454 - Immediate and Delayed Intrauterine Balloon in the Prevention of Adhesion Reformation After Hysteroscopic Adhesiolysis N/A
Recruiting NCT05003869 - Clinical and Basic Research on the Necessity of Scar Tissue Resection During Intrauterine Adhesions N/A
Completed NCT02744716 - Effects of Aspirin on Uterine Endometrial Repair Severe Intrauterine Adhesion N/A
Completed NCT04824430 - Assessment of Uterine Access, Uterine Patency and Intrauterine Adhesions Following Endometrial Ablation
Completed NCT01167296 - Safety of Leaving Cook Balloon Uterine Stent in Uterus for One Month Phase 4
Completed NCT03578172 - HMG Stimulation Versus HRT for Endometrial Preparation Prior to Blastocyst Transfer in Moderate to Severe IUA Patients N/A
Recruiting NCT04930913 - Three-dimensional Ultrasound Applying in Assessment of Intrauterine Adhesions