NCT04046302

Vaginal Dinoprostone Administration Prior to an Intrauterine Device Insertion in Multiparous Women.

Effect of Self-Administered Vaginal Dinoprostone on Pain Perception During Copper Intrauterine Device Insertion in Parous Women: a Randomized Controlled Trial

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications, and pain in multiparous women.

Detailed description

Women may experience pain and technical difficulties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally. Pain can be perceived during all steps of IUD insertion including the application of the tenaculum to the cervical lip, sounding the uterus and advancing the IUD introducer through the cervical canal inside the uterine cavity

Conditions

• IUD Insertion

Interventions

Type	Name	Description
DRUG	Dinoprostone	1 vaginal tablet of dinoprostone (3mg) (prostin® E2, Pharmacia \& Upjohn, Puurs, Belgium) self-inserted by participants 3 hours before scheduled IUD insertion appointment.
DRUG	placebo	one tablet of placebo self-inserted by participants 3 hours before scheduled IUD insertion appointment.

Timeline

• Start date: 2019-08-30
• Primary completion: 2020-01-10
• Completion: 2020-01-30
• First posted: 2019-08-06
• Last updated: 2020-03-10

Locations

1 site across 1 country: Egypt