Status:
COMPLETED
10% Lidocaine Spray for Intrauterine Device Insertion
Lead Sponsor:
Mahidol University
Conditions:
Contraception
Intrauterine Device
Eligibility:
FEMALE
18-45 years
Phase:
PHASE4
Brief Summary
Intrauterine device (IUD) insertion is a procedure that can cause pain. Fear of pain during IUD insertion is a barrier to use of this method. Currently, there is no recommended standard method for red...
Detailed Description
Intrauterine device (IUD) is a high efficacy long-acting reversible contraceptive method. However, IUD insertion is a procedure that require well-trained medical personnel and can cause pain in severa...
Eligibility Criteria
Inclusion
- Woman who required for Copper T IUD insertion
- Body mass index 18.5 - 30 kg/m2
- Communicable with Thai language
- New IUD user
Exclusion
- Suspicion of pregnancy
- Puerperal sepsis/Immediate post-septic abortion
- Untreated abnormal uterine bleeding
- Uterine anomaly/abnormal pathology distorting the uterine cavity
- Current pelvic inflammatory disease
- Untreated cervicitis/vaginitis
- Wilson's disease
- Copper allergy
- known hypersensitivity to local anaesthetic
- Analgesic or anxiolytic use within the last 24 h before the procedure
Key Trial Info
Start Date :
August 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 17 2019
Estimated Enrollment :
124 Patients enrolled
Trial Details
Trial ID
NCT03870711
Start Date
August 1 2018
End Date
December 17 2019
Last Update
January 30 2020
Active Locations (1)
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1
Nalinee Panichyawat
Ratchathewi, Bangkok, Thailand, 10400