search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


RCT: LNG-IUS insertion during menstruation compared with random insertion beyond menstruations in patient-perceived pain.


- candidate number15680
- NTR NumberNTR4258
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR12-nov-2013
- Secondary IDsNL45003.015.13 METC MMC in Veldhoven
- Public TitleRCT: LNG-IUS insertion during menstruation compared with random insertion beyond menstruations in patient-perceived pain.
- Scientific TitleRCT: LNG-IUS insertion during menstruation compared with random insertion beyond menstruations in patient-perceived pain.
- ACRONYMTIME-trial
- hypothesisIn theory insertion during menstruation is less painful because of a dilated cervical ostium during menstruation.
- Healt Condition(s) or Problem(s) studiedContraception, Pain, Insertion
- Inclusion criteriaWomen 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 receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-okt-2013
- planned closingdate1-sep-2014
- Target number of participants120
- Interventionsinsertion 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 outcomePatient-perceived pain during insertion of LNG-IUS using the Visual Analogue Scale (VAS)
- Secondary outcomeThe 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 siteN/A
- statusopen: 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
- Funding
(Source(s) of Monetary or Material Support)
Self Funding
- PublicationsN/A
- Brief summarySUMMARY
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)
- RECORD12-nov-2013 - 2-dec-2013


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl