Comparative Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in IUD Insertion

Contraception Clinical Trial

Official title:

Comparative Safety and Efficacy of Lidocaine Spray Versus Vaginal Dinoprostone in Relieving Pain During Levonorgestrel IUD Insertion

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04339361
• Other study ID #: lidocaine spray IUD
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: April 25, 2020
• Est. completion date: August 15, 2020

Study information

• Verified date: April 2020
• Source: Cairo University
• Contact: AHMED SAMY
• Phone: +201100681167
• Email: ahmedsamy8233[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

the aim of this study is to compare the safety and Efficacy of Lidocaine Spray Versus Vaginal dinoprostone in relieving pain during levonorgestrel IUD Insertion in nulliparous women

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 111
• Est. completion date: August 15, 2020
• Est. primary completion date: August 10, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• nulliparous women requesting levonorgestrel IUD insertion

Exclusion Criteria:

• multiparous women, allergy or contraindication to study drugs or contraindications to LNG-IUD insertion

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• lidocaine spray
four puffs (50 ml, 10 mg/puff) of lidocaine spray before tenaculum placement plus vaginal placebo 3 hours before IUD insertion
• vaginal dinoprostone
vaginal dinoprostone 3 mg will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement
• placebo
vaginal placebo will be given 3 hours before IUD insertion plus four puffs of saline spray before tenaculum placement

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	pain during IUD insertion	pain during IUD insertion assessed by 10 cm visual analog scale where 0 denotes no pain and 10 denotes the worst pain imaginable	2 minutes
Secondary	insertion duration	duration of LNG-IUD insertion from speculum in to speculum out	5 minutes