Womed Leaf: Womed Leaf™ device is composed of a uterine anti-adhesion film pre-loaded inside a flexible inserter.
Womed Leaf™ is inserted in the uterine cavity by the gynecologist surgeon as a film folded into a 5 mm diameter flexible inserter. Once released, the film will unfold and swell into the uterine cavity to keep uterus walls separated. It is degraded and discharged naturally through the cervix and vagina.
Study summary
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
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
Efficacy - IUA Severity — At second look hysteroscopy between 4 and 8 weeks Change of AFS score between pre-adhesiolysis and second-look hysteroscopy (AFS) score
The scale used to assess the severity of intrauterine adhesions is the American Fertility Society score. It is a 12 points composite score that adds-up 3 subcomponents: - Extend of adhesions (1 = less than 1/3 of the uterine cavity involved with adhesions to 4 = more than 2/3 of the uterine cavity involved with adhesions),
* Type of adhesions (1 = Filmy adhesions to 4 = dense adhesions)
* Menstrual pattern (0= normal to 4 = amenorrhea).
The final score allows the following prognostic classification:
1-4 = mild disease, 5-8 = moderate disease 9-12 = severe disease
Safety - Adverse Events — At second look hysteroscopy between 4 and 8 weeks Adverse events up to second look hysteroscopy.
Trial sites (15)
Facility
City
Region
Status
Gent UZ
Ghent
Belgium
Guangdong Maternal and Child Health Hospital
Guangzhou
China
Women's Hospital School Of Medicine Zhejiang University
Hangzhou
China
The Obstetrics & Gynecology Hospital Affiliated to Fudan University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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