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Mentaal welzijn en kwaliteit van leven na insertie van een LNG-IUD versus een Cu-IUD. Een prospectieve studie.

A prospective cohort study comparing mental wellbeing and quality of life after insertion of a LNG-IUD versus Cu-IUD.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON22570
Enrollment
420
Registered
2018-01-19
Start date
2018-03-01
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

Cu-IUD LNG-IUD Mental well being Quality of live Koper spiraal Mirena spiraal Kyleena spiraal Mentaal welzijn Kwaliteit van leven

Interventions

women willing to participate in the study are requested to answer a web-based questionnaire prior to the IUD insertion, on the day of insertion as well as three, six and twelve months after insertion.

Sponsors

Titus Health Care
Lead Sponsor

Eligibility

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 < 3 months prior to placement this IUD • IUD insertion while being under general anaesthetics. • IUD insertion within 6 weeks postpartum and 12 weeks after a caesarean are excluded. • Contraindications according to the product leaflets. • patients taking medication against a mental conditions

Design outcomes

Primary

MeasureTime frame
rimary 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.

Contacts

Public ContactE.R. Groenewoud

Postbus 10400

e.r.groenewoud@isala.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)