To compare the effects of LNG-IUD (Mirena® of Kyleena®) versus Cu-IUD (T-Safe® or Multi-Safe®) on mental well-being and quality of life.
ID
Source
Brief title
Condition
- Other condition
- Gonadotrophin and sex hormone changes
Synonym
Health condition
anticonceptie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
The number of women looking for long acting reversible contraception (LARC) is
on the rise in the Netherlands. A recent report by the Dutch centre for sexual
health over the period from 2012 till 2017 showed a substantial increase in the
number of women under the age of 25 opting for an intra-uterine device (IUD) as
contraceptive method of choice. The rise in the number of IUDs can
predominantly be ascribed to the growing popularity of the levonorgestrel IUD
(LNG-IUD). The promise of a reduction in the monthly amount of blood loss in
the absence of systemic effects seems to be the most important reason for women
to prefer a LNG-IUD over e.g. oral contraceptives or a Copper-IUD (Cu-IUD).
Shortly after the report of the Rutgers Stichting, a large prospective study
regarding the physiological responses to stress in women using the LNG-IUD was
published. This study showed that despite the low daily dose of levonorgestrel
release by the LNG-IUD significant effects on basal heart rate and the release
of cortisol are observed, disproving the common assumption that the LNG-IUD has
little to no systemic influence. Therefore, as well as other hormonal
contraceptives, LNG-IUD might have an effect on mental wellbeing and quality of
life. Cu-IUDs have been available for decades for women looking for LARC and
offer a true hormone free alternative to the LNG-IUD. In the Dutch GP
Guidelines (NHG) the T-Safe Cu380A and the Multiload IUD*s are the preferred
Cu-IUD due their high efficacy and low discontinuation rates. The Multi-Safe
IUD (generic Multiload IUD) is available since 2016 after the withdrawal of
Multiload from the Dutch market. Most comparative studies between LNG-IUD and
Cu-IUD so far have focussed on bleeding patterns, efficacy as well
discontinuation rates. So far, little notice has been paid on comparison of
mental health or quality of life.
Study objective
To compare the effects of LNG-IUD (Mirena® of Kyleena®) versus Cu-IUD (T-Safe®
or Multi-Safe®) on mental well-being and quality of life.
Study design
A randomized patient preference trial comparing mental wellbeing and quality of
life after insertion of a LNG-IUD or Cu-IUD.
Intervention
Randomization between Cu-IUD or LNG-IUD. If a patient is not willing to be
randomized she can participate in the parallel cohort study.
Study burden and risks
Given the fact that insertion of an IUD and the web-based questionnaires
participating patients are not exposed to any risks or benefits. This study
will hopefully result in improved counselling and thereby ultimately helping
patients decide which IUD suits their personal situation best. The estimated
total time that the questionnaires will take to fill in is approximately 15 to
20 minutes per questionnaire. So a total time investment of 75-100 minutes
after completion of all five questionnaires.
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Wilhelminalaan 12
Alkmaar 1815 JD
NL
Listed location countries
Age
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
• 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
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL64587.048.18 |
| Other | NTR - 6983 |