Dinoprostone vs Misoprostol Before LNG-IUD Insertion

IUD Insertion Pain Clinical Trial

Official title:

Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Women

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04301349
• Other study ID #: dinoprostone IUDs
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: March 15, 2020
• Est. completion date: June 30, 2020

Study information

• Verified date: March 2020
• Source: Cairo University
• Contact: AHMED SAMY, MD
• 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 vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: June 30, 2020
• Est. primary completion date: June 15, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• multiparous women requesting IUD insetion

Exclusion Criteria:

• active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol

Related Conditions & MeSH terms

• IUD Insertion Pain

Intervention

Drug:
• vaginal dinoprostone
two tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion
• vaginal misoprostol
two tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion
• placebo
two tablets of placebo 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 IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable	2 minutes
Secondary	duration of IUD insertion	duration of IUD insertion measured in minutes	5 minutes