|- candidate number||28468|
|- NTR Number||NTR6983|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-jan-2018|
|- Secondary IDs||ABR nummer 64587 |
|- Public Title||Mentaal welzijn en kwaliteit van leven na insertie van een LNG-IUD versus een Cu-IUD. Een prospectieve studie. |
|- Scientific Title||A prospective cohort study comparing mental wellbeing and quality of life after insertion of a LNG-IUD versus Cu-IUD. |
|- ACRONYM||E-CHIQ study|
|- hypothesis||The hypothesis of this study is that a difference in mental well-being can be observed after insertion of an LNG-IUD compared to Cu-IUD insertion. |
|- Healt Condition(s) or Problem(s) studied||Quality of life, LNG-IUD, Cu-IUD, Copper IUD, Kyleena IUD, Mirena IUD, Mental well-being|
|- 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
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-mrt-2018|
|- planned closingdate||1-sep-2019|
|- Target number of participants||420|
|- 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. Questions regard mental well-being, quality of life, bleeding pattern, satisfaction with their IUD, reasons for discontinuation and unintended pregnancy. |
|- Primary outcome||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 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. |
|- Timepoints||The comparison with regard to the primary endpoint will be made prior to and at the time of IUD insertion and at three, six and twelve months after IUD insertion. |
|- Trial web site||not jet available|
|- CONTACT FOR PUBLIC QUERIES||drs. E.R. Groenewoud|
|- CONTACT for SCIENTIFIC QUERIES||drs. E.R. Groenewoud|
|- Sponsor/Initiator ||Titus Health Care B.V. |
(Source(s) of Monetary or Material Support)
|Titus Health Care B.V. |
|- Brief summary||The number of women looking for long acting reversible contraception (LARC) is on the rise in the Netherlands. 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. 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. The objective of this prospective cohort study is therefore to compare the effects of LNG-IUD versus Cu-IUD (T-Safe or Multi-Safe) on mental well-being and quality of life. Secundary 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.|
|- Main changes (audit trail)||Study is investigator initiated.|
|- RECORD||19-jan-2018 - 4-feb-2018|