PREG2 is a randomized controlled trial that aims to evaluate efficacy in preventing intrauterine adhesion recurrence after hysteroscopic adhesiolysis of a novel intrauterine barrier film named Womed Leaf
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Women with moderate or severe intrauterine adhesions according to the AFS classification, i.e AFS score \>=5, confirmed by hysteroscopy right before adhesiolysis
* Scheduled for hysteroscopic adhesiolysis
* Age above or equal to 18
* Subjects who are willing to provide a written informed consent.
* Subjects who can comply with the study follow-up (second look hysteroscopy) and other study requirements
* Subjects who agree to refrain from intercourse or use a reliable form of barrier contraception to prevent unintended pregnancy until the follow-up hysteroscopy.
* Subjects who agree to avoid all intrauterine devices (IUDs) until the follow-up hysteroscopy.
Exclusion Criteria:
Pre-operative criteria
* Post menopause
* Pregnant (confirmed by a positive pregnancy test) or lactating
* Abnormal uterine cavity according to ESHRE classification I to V such as unicornis, bicornis, septate, duplex
* Known or suspected endometrial hyperplasia
* History of cervical or endometrial cancer
* Active pelvic infection or history of pelvic peritonitis
* History of endometrial ablation
* Known contraindication or hypersensitivity to Womed Leaf component
* Current participation in another clinical investigation that has not yet received the primary endpoint.
* Any other condition that makes participation in the study contrary to the patient's best interests.
Intra-operative criteria, post adhesiolysis:
* Perforation during adhesiolysis
* Uterine depth \< 5cm or \> 10cm
What they're measuring
1
Efficacy - IUA Severity
Timeframe: At second look hysteroscopy between 4 and 8 weeks
2
Safety - Adverse Events
Timeframe: At second look hysteroscopy between 4 and 8 weeks