Is two-dimensional ultrasound necessary six weeks after insertion of the 52-mg levonorgestrel-releasing intrauterine system (LNG-IUS) contraceptive?
| ISRCTN | ISRCTN11725991 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN11725991 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 15.025 |
| Sponsor | Máxima Medisch Centrum |
| Funder | investigator initiated and funded |
- Submission date
- 29/07/2021
- Registration date
- 07/09/2021
- Last edited
- 07/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Plain English summary of protocol
Background and study aims
The correct position of the contraceptive levonorgestrel intrauterine system (LNG-IUS) can be confirmed by two-dimensional ultrasound (2DUS). However, best the timing of a routine 2DUS to confirm the correct position is subject to discussion. The main aim of this study was to assess how often the LNG-IUS is found to be incorrectly positioned on 2DUS during routine investigation at six weeks after insertion in the gynecological outpatient department. Additionally, the study will investigate the relation between malposition of the LNG-IUS and clinical symptoms like unacceptable bleeding patterns and pelvic pain.
Who can participate?
Women seeking a 52mg LNG-IUS (Mirena®), over 18 years of age, for contraception or treatment of heavy menstrual bleeding.
What does the study involve?
2DUS was performed to check the position of the IUD immediately after insertion and six weeks later. Women were excluded if they did not attend the appointment for 2DUS six weeks after insertion. Women were asked to complete questionnaires six weeks after insertion and were asked about bleeding pattern and pelvic pain.
What are the possible benefits and risks of participating?
No additional benefits or risks to participants are anticipated.
Where is the study run from?
Máxima Medical Centre (Netherlands)
When is the study starting and how long is it expected to run for?
May 2015 to December 2018
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
Patty van der Heijden, pattyvanderheijden@gmail.com
Contact information
Scientific
Elkerliek Hospital
Wesselmanlaan 25
Helmond
5707HA
Netherlands
 ORCID ID |
0000-0002-5290-7646 |
|---|---|
| Phone | +31 615699305 |
| pvanderheijden@elkerliek.nl |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Single-centre observational study |
| Secondary study design | Cohort study |
| Participant information sheet | 40230 PIS.doc |
| Scientific title | Is two-dimensional ultrasound (2DUS) necessary six weeks after insertion of 52-mg LNG-IUS? |
| Study objectives | In this prospective cohort study we assessed the additional value of 2DUS six weeks after insertion. We described the frequency of malposition and the relationship between malposition of the LNG-IUS and clinical symptoms like bleeding pattern and/or pelvic pain. |
| Ethics approval(s) | Approved 23/05/2015, Dagelijks Bestuur METC (Máxima Medisch Centrum, Locatie Veldhoven, Postbus 7777, 5500 MB Veldhoven; 3140-8888525; m.rutten@mmc.nl), ref: 15.025 |
| Health condition(s) or problem(s) studied | Diagnostics of malposition and complaints in women with 52-mg LNG-IUS |
| Intervention | Immediately after insertion of the LNG-IUS, the position of the LNG-IUS was assessed with the 2DUS by the resident, gynaecologist or physician assistant who performed the insertion. Six weeks after insertion a 2DUS was performed to evaluate the position of the LNG-IUS. Participants were asked to complete questionnaires 6 weeks after insertion. In the questionnaires women were asked about their bleeding pattern (presence of bleeding and/or spotting: ‘no bleeding’, ‘regular menstruation’, ‘sometimes a day of spotting (maximum of once a week)’, ‘heavy menstrual bleeding’, ‘several days a week bleeding days’, ‘several days a week spotting days’, ‘continuously spotting’, ‘complete irregular cycle’). Women were asked to rate pelvic pain on a five-point Likert scale. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | levonorgestrel |
| Primary outcome measure(s) |
Incidence of malposition on 2DUS during routine investigation six weeks after insertion |
| Key secondary outcome measure(s) |
Clinical symptoms at six weeks: |
| Completion date | 31/12/2018 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 500 |
| Total final enrolment | 500 |
| Key inclusion criteria | 1. Women who visited our clinic for the insertion of a 52mg LNG-IUS (Mirena®) for contraception or treatment of heavy menstrual bleeding 2. Over 18 years of age |
| Key exclusion criteria | 1. Presence of intracavitary polyps or fibroids on 2DUS prior to insertion 2. Unprotected intercourse one month prior to insertion if insertion took place outside menstruation 3. Women were excluded for analyses if no ultrasound was performed six weeks after insertion |
| Date of first enrolment | 01/03/2015 |
| Date of final enrolment | 31/12/2016 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Veldhoven
5504DB
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Available on request |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding author on reasonable request. (pattyvanderheijden@gmail.com) |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 04/10/2022 | 07/11/2023 | Yes | No | |
| Participant information sheet | In Dutch | 10/08/2021 | No | Yes | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Protocol file | In Dutch | 10/08/2021 | No | No |
Additional files
- 40230 PIS.doc
- In Dutch
- 40230 Protocol.docx
- In Dutch
Editorial Notes
07/11/2023: Publication reference added.
12/08/2021: Trial's existence confirmed by Máxima Medisch Centrum.
