|- candidate number||15680|
|- NTR Number||NTR4258|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||12-nov-2013|
|- Secondary IDs||NL45003.015.13 METC MMC in Veldhoven|
|- Public Title||RCT: LNG-IUS insertion during menstruation compared with random insertion beyond menstruations in patient-perceived pain.|
|- Scientific Title||RCT: LNG-IUS insertion during menstruation compared with random insertion beyond menstruations in patient-perceived pain.|
|- hypothesis||In theory insertion during menstruation is less painful because of a dilated cervical ostium during menstruation. |
|- Healt Condition(s) or Problem(s) studied||Contraception, Pain, Insertion|
|- Inclusion criteria||Women who menstruate with a wish for LNG-IUS.|
|- Exclusion criteria||• Women with an abnormal uterine cavity (myomas, polyps) determined by a TransVaginalUltrasound (TVU)|
• Women with a failed insertion in a previous attempt either bij general practitioner or other Gyneacologist
• Women with a LNG-IUS in situ with request for reinsertion
• Women younger than 18 years
• Peri- or postmenopausal women
• Women with a positive pregnancy test or who had unprotected intercourse since their menses
• Amenorrhea after pregnancy
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2013|
|- planned closingdate||1-sep-2014|
|- Target number of participants||120|
|- Interventions||insertion of LNG-IUS DURING (controlgroup) versus Beyond menstruation (interventiongroup). After insertion, which only takes about 5 minutes, patients are asked to give a VAS scale (0-100 mm) to describe the pain perceived DURING insertion|
|- Primary outcome||Patient-perceived pain during insertion of LNG-IUS using the Visual Analogue Scale (VAS)|
|- Secondary outcome||The secondary outcome will be easiness of insertion by the health care provider, scaled as easy or difficult (scored as difficult whenever advanced tools were necessary to use for a successful insertion, for example cervical dilatation or hysteroscopy) and short-term outcomes, i.e. patient satisfaction with LNG- IUS (scaled using the Likert scale ), removal rate, expulsion rate and pregnancy rate, and bleeding pattern during a follow-up of three months. After 3 months a 2D and 3D ultrasound will be made to check for expulsion and pregnancy rates.|
|- Timepoints||- Directly after insertion (VAS scale)
- monthly until 3 months after insertion of LNG-IUS (using questionnaires for satisfaction using the Likert scale and Pictorial Blood Assessment charts (PBAC)
-after 3 months a 2D and 3D ultrasound will be made to check the lokalisation (check for expulsion/pregnancy, i.e. secondary outcomes)|
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| P.A.H.H. Heijden, van der|
|- CONTACT for SCIENTIFIC QUERIES|| P.A.H.H. Heijden, van der|
|- Sponsor/Initiator ||Initiator|
(Source(s) of Monetary or Material Support)
|- Brief summary||SUMMARY |
Rationale/ Objective: A levonorgestrel releasing intrauterine system (LNG-IUS) is a common contraceptive. LNG-IUS induces endometrial suppression and reduces menstrual bleeding which makes this intrauterine system a very popular form of contraception. LNG-IUS is also used in treatment of menorrhagia, endometriosis and in protection of endometrium in women receiving estrogen replacement therapy. Insertion is performed by a general practitioner or a gynaecologist mostly during menstruation. Insertion during menstruation prevents unintentional insertion during (early) pregnancy. In theory insertion during menstruation is less painful because of a dilated cervical ostium during menstruation. Also in theory, starting release of progestogens could be better during the breakdown of the endometrium in order to prevent prolonged bleedings. For copper-IUDs it is proven there is no difference in timing during menstrual cycle regarding patient-perceived pain. In this randomized study, timing during or beyond menstruation will be compared regarding differences in patient-pain perception and easiness of insertion as percepted by the doctor.
Study design: Randomized controlled trial according to an intention to treat analysis.
Study population: Women who are planned for an insertion of LNG-IUS as contraceptive or treatment for menorrhagia. Before study entry, we will assess the risk for pregnancy.
Intervention (if applicable): insertion of LNG-IUS during menstruation versus beyond menstruation.
Main study parameters/endpoints: Primary outcome is the patient-perceived pain during insertion of LNG-IUS using the VAS scale. Secondary outcomes are ease of insertion and short-term outcomes, i.e. satisfaction, removal, expulsion, pregnancy rates, and bleeding pattern during a follow-up of three months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: As this study compares one common treatment with two different regimens, it will not impose extra risk on the participants. Participants fill out questionnaires at three different occasions and a pictorial blood assessment chart (PBAC) daily within the three months following. After 3 months we will perform a 2D and 3D ultrasound to check for expulsion and pregnancy rates.
Country of recruitment: The Netherlands
|- Main changes (audit trail)|
|- RECORD||12-nov-2013 - 2-dec-2013|