NCT02078063

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2013

Typical duration for phase_3

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2013

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 5, 2014

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

4 years

First QC Date

November 21, 2013

Last Update Submit

April 25, 2018

Conditions

Insertion of Intrauterine Contraception

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Acceptability

    30 minutes after insertion

Study Arms (2)

Mepivacaine

EXPERIMENTAL

10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter

Drug: Mepivacaine

NaCL

PLACEBO COMPARATOR

10 ml NaCl 9mg/ml instilled into the uterus through a hydrosonography catheter

Drug: Placebo

Interventions

MepivacaineDRUG

10 ml of Mepivacaine for injection (Carbocain®) 10 mg/ml instilled into the uterus through a hydrosonography catheter

Also known as: Carbocain (R)
Mepivacaine
PlaceboDRUG

10 ml of NaCl 0.9 mg/ml instilled into the uterus through a hydrosonography catheter

NaCL

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Dept of Obstetrics and Gynecology, Danderyd Hospital

Stockholm, 182 88, Sweden

Location

Upplands Väsby Ungdomsmottagning

Stockholm, Sweden

Location

Related Publications (1)

  • Envall N, Lagercrantz HG, Sunesson J, Kopp Kallner H. Intrauterine mepivacaine instillation for pain relief during intrauterine device insertion in nulliparous women: a double-blind, randomized, controlled trial. Contraception. 2019 Jun;99(6):335-339. doi: 10.1016/j.contraception.2019.02.003. Epub 2019 Mar 1.

    PMID: 30831101DERIVED

MeSH Terms

Interventions

Mepivacaine

Intervention Hierarchy (Ancestors)

PiperidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Helena Kopp Kallner, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

November 21, 2013

First Posted

March 5, 2014

Study Start

November 1, 2013

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

SE(2)