NCT00405288

The Safety of Proctofoam-HC in the Third Trimester of Pregnancy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 408 (actual)
• Sponsor: The Hospital for Sick Children · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the fetal safety of topical application of Proctofoam-HC®, an antihemorrhoidal, in the third trimester of pregnancy.

Detailed description

Hemorrhoids are a frequent condition in pregnancy. The rate is increased as pregnancy progresses, and they affect up to 24% of pregnant women in the third trimester. Complications of untreated hemorrhoids include bleeding, prolapse, soiling, discharge with perianal irritation and itching, and in severe cases, severe pain and venous engorgement which could even lead to thrombosis and infarction. Hemorrhoids are treated with a variety of suppositories and gels, based on analgesic and anti-inflammatory effects. The safety of these antihemorrhoidal products has not yet been documented in pregnant women. Proctofoam-HC® has been on the Canadian market for 25 years. It combines the anti-inflammatory action of hydrocortisone with the surface anesthetic effect of pramoxine HCl. It is approved for temporary relief of anorectal inflammation, pruritus, pain and swelling associated with haemorrhoids, fissures, pruritus ani, cryptitis, proctitis and postoperative pain. We hypothesize that local application of Proctofoam-HC® in the third trimester of pregnancy is safe for the mother and fetus.

Conditions

• Hemorrhoids
• Pregnancy

Interventions

Type	Name	Description
DRUG	Proctofoam-HC®	Observational study of the exposure to Proctofoam-HC®

Timeline

• Start date: 2006-11-01
• Primary completion: 2009-11-01
• Completion: 2010-06-01
• First posted: 2006-11-30
• Last updated: 2014-02-05
• Results posted: 2014-02-05

Locations

2 sites across 1 country: Canada