The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
Recruitment status was Recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Safety of Proctofoam-HC in the Third Trimester of Pregnancy|
- Child developmental milestones at approximately 6 months post-delivery
- Child anthropometric data at approximately 6 months post-delivery
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||November 2009|
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.
|Contact: Gideon Koren, MDfirstname.lastname@example.org|
|The Hospital for Sick Children||Recruiting|
|Toronto, Ontario, Canada, M5G 1X8|
|Contact: Gideon Koren, MD 416 813 5778 email@example.com|
|Principal Investigator: Gideon Koren, MD|
|Sub-Investigator: Arthur Staroselsky, MD|
|Mount Sinai Hospital||Recruiting|
|Toronto, Ontario, Canada, M5G 1X5|
|Contact: Paul Bernstein, MD 416-586-4800 ext 5236 firstname.lastname@example.org|
|Principal Investigator: Paul Bernstein, MD|
|Principal Investigator:||Gideon Koren, MD||The Hospital for Sick Children, Toronto Canada|