Lidocaine In-situ Gel Prior to Intrauterine Device Insertion in Women With no Previous Vaginal Delivery

• Status: Completed
• Trial end date: 2020-05-31
• Target enrollment: 0
• Participant gender: Female

Summary

Long-acting reversible contraception methods are highly effective methods for reduction of the unplanned pregnancy rate worldwide. The intrauterine device is a single procedure that provides reliable, effective and long term contraception for many women. However, the insertion procedure can be associated with a troublesome degree of pain that prevent some women from choosing its use. Different interventions have been described to decrease pain perception during intrauterine device insertion with no agreement on an effective one. Pre-insertion oral ibuprofen, diclofenac, nitroprusside, local anesthetics as lidocaine and prostaglandins has been reported with variable degrees of success .

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assiut University
• Treatments: Lidocaine

Criteria

Inclusion criteria:

• Non-pregnant women

• Women that did not receive any analgesics or misoprostol in the 24 hours prior to insertion

• Women who delivered only by caesarean section

Exclusion criteria:

• Women with any uterine abnormalities as congenital anomalies, endometrial lesions, adenomyosis, fibroids

• Those with a Category 3 or 4 conditions for intrauterine device insertion according to the WHO Medical Eligibility Criteria for contraceptive use

• Allergy to lidocaine.

• Women refuse to participate in the study