Insertion of Intrauterine Contraception
Conditions
Brief summary
Use of long acting reversible contraception (LARC) such as implants or intrauterine contraception (IUC) has been shown to reduce repeat abortions. LARCs have the advantage of being independent of user error and are considered to be underused, especially among young individuals where oral methods have high rates of user failure. IUC is often underused in young or nulliparous women due to fear of pain at insertion. 10 ml of mepivacaine (10mg/ml) or 10ml of sodium hydrochloride will be injected into the uterine cavity through a hydrosonography catheter before the tenaculum has been applied but prior to sounding and to insertion of the IUC. The investigators' hypothesis is that instillation of 10 ml (10mg/ml) mepivacaine though a hydrosonography catheter prior to any instrument placement will provide more effective pain relief than instillation of 10 ml placebo (sodium chloride 9mg/ml). Primary objective: To evaluate the difference in pain score at the time of the insertion of the IUC between treatment and control group. Secondary objectives: To evaluate acceptability of the procedure.
Interventions
DRUGMepivacaine
10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter
DRUGPlacebo
10 ml of NaCl 0.9 mg/ml instilled into the uterus through a hydrosonography catheter
Sponsors
Karolinska Institutet
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* over 18 years of age and * opting for IUC for contraception * with a negative pregnancy test * willing to participate in the study after it has been explained orally and in written
Exclusion criteria
* previous conisation, * known cervical stenosis, * signs of ongoing genital infection, * known uterine abnormality, * any condition resulting in bleeding disorder or contraindication to any local anestetic will be excluded
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| pain | On day of insertion | difference in pain score (VAS)at the time of the insertion of the IUC between treatment and control group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability | 30 minutes after insertion | They will be asked if the would opt to have this type of pain relief were the ever to insert a new IUC (yes/no), if they would recommend this type of pain relief to any other women (yes/no) and to state how the procedure was compared to their expectations (worse/as expected/better). |
Countries
Sweden
Outcome results
None listed