Intrauterine Adhesion Clinical Trial
Official title:
Prevention of Postoperative Adhesion Reformation by Intrauterine Balloon Therapy: a Randomized Controlled Trial
Verified date | August 2019 |
Source | Fu Xing Hospital, Capital Medical University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 200 |
Est. completion date | November 15, 2018 |
Est. primary completion date | November 15, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: 1. women aged 18-40 years; 2. moderate to severe intrauterine adhesion (AFS score=5); 3. no previous history of hysteroscopic adhesiolysis in our hospital; 4. written consent obtained 5. agreement to have second-look and third-look hysteroscopy. Exclusion Criteria: 1. minimal adhesion (AFS score <5); 2. previous hysteroscopic adhesiolysis in our hospital. |
Country | Name | City | State |
---|---|---|---|
China | Fu Xing Hospital | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Fu Xing Hospital, Capital Medical University |
China,
ASHERMAN JG. Amenorrhoea traumatica (atretica). J Obstet Gynaecol Br Emp. 1948 Feb;55(1):23-30. — View Citation
ASHERMAN JG. Traumatic intra-uterine adhesions. J Obstet Gynaecol Br Emp. 1950 Dec;57(6):892-6. — View Citation
March CM. Intrauterine adhesions. Obstet Gynecol Clin North Am. 1995 Sep;22(3):491-505. Review. — View Citation
Orhue AA, Aziken ME, Igbefoh JO. A comparison of two adjunctive treatments for intrauterine adhesions following lysis. Int J Gynaecol Obstet. 2003 Jul;82(1):49-56. — View Citation
Saravelos SH, Jayaprakasan K, Ojha K, Li TC. Assessment of the uterus with three-dimensional ultrasound in women undergoing ART. Hum Reprod Update. 2017 Mar 1;23(2):188-210. doi: 10.1093/humupd/dmw040. Review. — View Citation
Saravelos SH, Li TC. Ultrasound-guided treatment of intrauterine adhesions in the outpatient setting. Ultrasound Obstet Gynecol. 2017 Aug;50(2):278-280. doi: 10.1002/uog.16218. — View Citation
Saravelos, S.H. & Li, TC. Gynecol Surg (2016) 13: 403. doi:10.1007/s10397-016-0972-2
Valle RF, Sciarra JJ. Intrauterine adhesions: hysteroscopic diagnosis, classification, treatment, and reproductive outcome. Am J Obstet Gynecol. 1988 Jun;158(6 Pt 1):1459-70. — View Citation
Yu D, Wong YM, Cheong Y, Xia E, Li TC. Asherman syndrome--one century later. Fertil Steril. 2008 Apr;89(4):759-79. doi: 10.1016/j.fertnstert.2008.02.096. Review. — View Citation
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) |
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