Postoperative Intermittent Intrauterine Balloon Dilatation Therapy.
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|ClinicalTrials.gov Identifier: NCT03131596|
Recruitment Status : Completed
First Posted : April 27, 2017
Results First Posted : September 13, 2019
Last Update Posted : September 13, 2019
|Condition or disease||Intervention/treatment||Phase|
|Intrauterine Adhesion||Procedure: IUB dilatation therapy||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||200 participants|
|Intervention Model:||Parallel Assignment|
|Masking Description:||Both surgeons conducting the hysteroscopic surgery and follow-up hysteroscopy were blinded to the patient group allocation.|
|Official Title:||Prevention of Postoperative Adhesion Reformation by Intrauterine Balloon Therapy: a Randomized Controlled Trial|
|Actual Study Start Date :||May 15, 2017|
|Actual Primary Completion Date :||November 15, 2017|
|Actual Study Completion Date :||November 15, 2018|
Experimental: IUB dilatation therapy
The patient will have Foley-catheter intrauterine balloon dilatation 2 weeks and 6 weeks after hysteroscopic adhesiolysis. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.
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.
No Intervention: control group
Patient will not undergo any balloon therapy. A second-look hysteroscopy will be carried out in the early proliferative phase 4 weeks after the surgery and third-look hysteroscopy will be carried out 8 weeks after the surgery.
- Number of Participants With Adhesion Reformation (American Fertility Society Score of Greater Than 0) 8 Weeks Later After the Index Surgery [ Time Frame: at 8 weeks post-operation ]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.
- The American Fertility Society Score 8 Weeks After Operation [ Time Frame: at 8 weeks post-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.
- Pictorial Blood Loss Assessment Chart Score 8 Weeks After Operation [ Time Frame: at 8 weeks post-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.
- Pregnancy Outcome Within 12 Months Follow-up After Third Look Hysteroscopy [ Time Frame: within 12 months after third look hysteroscopy(8 weeks post-operation) ]number of patients who have pregnancy, miscarriage and ectopic pregnancy within12 months follow-up
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03131596
|Fu Xing Hospital|
|Beijing, Beijing, China, 100038|
|Study Chair:||Tinchiu Li||Fuxing Hospital,Capital Medical University，China|