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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: Female

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Collaborator: Duchesnay Inc.
• Treatments: Cortisol succinate; Hydrocortisone; Hydrocortisone 17-butyrate 21-propionate; Hydrocortisone acetate; Hydrocortisone hemisuccinate; Pramoxine

Criteria

Inclusion Criteria:

• For intervention group, any pregnant woman with a primary anorectal condition during the third trimester of pregnancy

• For control group, women in third trimester of pregnancy not treated with Proctofoam, and matched on maternal age and smoking status

• for either group,no other pregnancy complications

Exclusion Criteria:

• exposure to known teratogens during pregnancy as evident either during the prenatal or postnatal interview

• insufficient English language skills to understand the questionnaires and assessment material

• Women who have received other corticosteroid medications (systemic or topical)during pregnancy

• Women with the following conditions: abscess, fistula, tuberculosis, varicella, acute Herpes Simplex or fungal infection

• age less than 18 years

• History of previous reaction to any of the product's components, such as: local irritation, hypertrichosis, hypopigmentation, etc.

• Known Intrauterine Growth Restriction (IUGR) or a chronic state that may cause IUGR (SLE, placental insufficiency).

• Multi fetal pregnancy

• Binge alcohol consumption (5 or more drinks on one occasion,in a row or within a short period of time)