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Prevalence of intrauterine adhesions after NovaSure ablation with application of Hyaluronic acid

Prevalence of intrauterine adhesions after NovaSure ablation with application of Hyaluronic acid

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON23959
Enrollment
20
Registered
2019-05-06
Start date
2019-06-01
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraurineadhesions after endometrial ablation

Interventions

Intrauterine instillation of MateRegen gel after NovaSure treatment.

Sponsors

none
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: • Women suffering symptoms from HMB, scheduled for a NovaSure endometrial ablation • Women in pre-menopausal age

Exclusion criteria

Exclusion criteria: • Women younger than 34 • Women with a desire to preserve fertility • Women with intracavitary pathology or big intramural myoma seen by transvaginal ultrasound. • Women with a history of a previous endometrial ablation or curettage • Women with cervix pathology

Design outcomes

Primary

MeasureTime frame
We will investigate the prevalence and describe the severity of IUAs (using a valid scoring system, the American Fertility Society (AFS) classification system) following NovaSure treatment for HMB with NCH gel compared to a NovaSure treatment without the NCH gel. In order to prepare for a future hypothesis testing randomized trial.

Secondary

MeasureTime frame
We will also investigate the complications (like uterus perforation and infection) that can occur during administration of the NCH gel in the uterus. Also, we will investigate dysmenorrhoea/ abdominal pain, PBAC score and menstrual bleeding pattern and patient’s satisfaction between the group of patients following NovaSure treatment with NCH and without the NCH gel.

Contacts

Public ContactElke Thijs

Maxima Medisch Centrum

elke.thijs@mmc.nl7816

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)