In this randomized study, timing during (day 1-7 of the menstruation cycle WITH vaginal blood loss) or beyond menstruation (in menstruation cycle day 8 and further WITHOUT vaginal blood loss) will be compared regarding differences in patient-…
ID
Source
Brief title
Condition
- Menstrual cycle and uterine bleeding disorders
- Obstetric and gynaecological therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Primary outcome is the patient-perceived pain during insertion of LNG-IUS using
the VAS scale.
Secondary outcome
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.
Background summary
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.
Study objective
In this randomized study, timing during (day 1-7 of the menstruation cycle WITH
vaginal blood loss) or beyond menstruation (in menstruation cycle day 8 and
further WITHOUT vaginal blood loss) will be compared regarding differences in
patient-perceived pain.
The secondary outcome will be easiness of insertion by the Physician Assistant,
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,
removal rate, expulsion rate and pregnancy rate, and bleeding pattern during a
follow-up of three months. After three months we will perform a 2D/3D
ultrasound investigate if malposition is related tot the secundary outcomes.
Study design
Randomized controlled trial according to an intention to treat analysis.
Intervention
insertion of LNG-IUS beyond menstruation.
Study burden and risks
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 three months we will perform a 2D/3D ultrasound investigate if
malposition is related tot the secundary outcomes. The time to make the two
ultrasounds will take approximately 5 minutes. In addition, it will take extra
time for the patient to travel to the hospital, which depends on the place of
residence.
De Run 4600
Veldhoven 5500MB
NL
De Run 4600
Veldhoven 5500MB
NL
Listed location countries
Age
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, or with a LNG-IUS in situ and wish for change
* 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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL45003.015.13 |
| OMON | NL-OMON23626 |