Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion

Contraception Clinical Trial

Official title:

Comparative Safety and Efficacy of Vaginal Dinoprostone Versus Lidocaine-prilocaine Cream in Copper IUD Insertion in Nulliparous Women: a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04340778
• Other study ID #: dinoprostone vs LP cream
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: April 30, 2020
• Est. completion date: September 5, 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 the present study is to Compare Safety and Efficacy of Vaginal dinoprostone Versus Lidocaine-prilocaine Cream in copper IUD Insertion in nulliparous women: a randomized controlled trial

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 210
• Est. completion date: September 5, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• nulliparous women requesting copper IUD insertion

Exclusion Criteria:

• multiparous women, active vaginal or cervical infections and contraindications to IUD Insertion.

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• vaginal dinoprostone
vaginal dinoprostone 3 mg will be given 3 hours before copper IUD insertion plus inert placebo cream will be applied on the cervix at the time of IUD insertion
• Lidocaine-prilocaine Cream
Lidocaine-prilocaine Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion
• placebo
inert placebo Cream will be applied on the cervix at the time of IUD insertion plus vaginal placebo tablet will be given 3 hours prior to IUD insertion

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: visual analog scale	pain during copper IUD insertion evaluated by 10 cm visual analog scale where 0 denotes no pain and 10 cm denotes the worst pain imaginable	5 minutes
Secondary	duration of insertion	duration of insertion from speculum in to speculum out	5 minutes