Incidence and predictors of re-intervention after Novasure endometrial ablation: a validation study in patients with abnormal uterine bleeding with data extraction from the Electronic Health Record and a Clinical Data Collector.

Effectivity of Novasure endometrial ablation for heavy menstrual bleeding: EHR vs CDC (novaSure Ehr vErsus cDc)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON20077

Enrollment

120

Registered

2021-01-19

Start date

2021-01-19

Completion date

Unknown

Last updated

2024-02-28

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

Conditions

Abnormal Uterine Bleeding

Interventions

Novasure endometrial ablation

Eligibility

Inclusion criteria

Inclusion criteria: Woman who suffer from abnormal uterine bleeding and who previously underwent Novasure treatment in 2018 in Máxima MC

Exclusion criteria

Exclusion criteria: Previous surgical intervention for heavy menstrual bleeding

Design outcomes

Primary

Measure	Time frame
Surgical re-intervention in Máxima MC in women with abnormal uterine bleeding who underwent Novasure treatment in 2018	—

Secondary

Measure	Time frame
- Patient characteristics: age, BMI, height and weight - Time between Novasure and re-intervention - Pre-existent Tubal ligation - Pre-existent dysmenorrhea - Uterine position - Time and power ablation - Analgesia (sedation, treatment room, Operating Room)	—

Contacts

Public ContactJ. Leemans

Máxima Medisch Centrum

jaklien.leemans@mmc.nl040-8887811

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)