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Mental wellbeing and quality of life after insertion of a LNG-IUD or Cu-IUD. A randomized patient preference trial.

Mental wellbeing and quality of life after insertion of a LNG-IUD or Cu-IUD. A randomized patient preference trial. - Quality of life after LNG-IUD versus Cu-IUD (E-CHIQ study).

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON48848
Enrollment
394
Registered
2018-08-20
Start date
2018-11-26
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

anticonceptie well-being

Interventions

Randomization between Cu-IUD or LNG-IUD. If a patient is not willing to be randomized she can participate in the parallel cohort study.

Sponsors

Noordwest Ziekenhuisgroep
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age; between 18 and 45 years. - Wish for LARC by means of a LNG-IUD or Cu-IUD for a minimum period of 12 months. - Willing to fill out 5 questionnaires, taking 15 to 20 minutes per questionnaire. - Access to internet and sufficient understanding of Dutch language. - Willing to provide informed consent.

Exclusion criteria

Exclusion criteria: • Cu-IUD insertion as emergency contraception. • Patients with heavy bleeding pattern/problems or with a wish for less blood-loss. • Patients with an Cu-IUD or LNG-IUD

Design outcomes

Primary

MeasureTime frame
Primary endpoint of this prospective cohort study is to determine whether or not a difference in mental well-being can be observed between patients receiving an LNG-IUD versus an Cu-IUD. The comparison will be made prior to and at the time of IUD insertion and at three, six and twelve months after IUD insertion.

Secondary

MeasureTime frame
Secondary outcomes that will be analysed involve overall quality of life, bleeding pattern, satisfaction with their IUD, reasons for discontinuation, sexual functioning and unintended pregnancy at 3, 6 and 12 months.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)