Insertion of Intrauterine Contraception Clinical Trial
Official title:
Mepivacaine for Pain Relief at Insertion of Intrauterine Contraception
| Verified date | April 2018 |
| Source | Karolinska Institutet |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 86 |
| Est. completion date | November 2017 |
| Est. primary completion date | November 2017 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Dept of Obstetrics and Gynecology, Danderyd Hospital | Stockholm | |
| Sweden | Upplands Väsby Ungdomsmottagning | Stockholm |
| Lead Sponsor | Collaborator |
|---|---|
| Karolinska Institutet |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | pain | difference in pain score (VAS)at the time of the insertion of the IUC between treatment and control group. | On day of insertion | |
| Secondary | Acceptability | 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). | 30 minutes after insertion |