The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
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:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||The Safety of Proctofoam-HC in the Third Trimester of Pregnancy|
- Birth-weight [ Time Frame: at birth ] [ Designated as safety issue: Yes ]
- Child developmental milestones at approximately 6 months post-delivery [ Time Frame: 6 months after delivery ] [ Designated as safety issue: Yes ]
- Child anthropometric data at approximately 6 months post-delivery [ Time Frame: 6 months after delivery ] [ Designated as safety issue: Yes ]
|Study Start Date:||November 2006|
|Study Completion Date:||June 2010|
|Primary Completion Date:||November 2009 (Final data collection date for primary outcome measure)|
Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation.
Observational study of the exposure to Proctofoam-HC®
Control, who were not exposed to any teratogens during the course of the pregnancy and to Proctofoam-HC, any of its components, or any other topical corticosteroids or local anaesthetics during the course of their pregnancy.
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.
|The Hospital for Sick Children|
|Toronto, Ontario, Canada, M5G 1X8|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Principal Investigator:||Gideon Koren, MD||The Hospital for Sick Children, Toronto Canada|