Status:
COMPLETED
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
Lead Sponsor:
The Hospital for Sick Children
Collaborating Sponsors:
Duchesnay Inc.
Conditions:
Hemorrhoids
Pregnancy
Eligibility:
FEMALE
18+ years
Brief 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 hemorrh...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
408 Patients enrolled
Trial Details
Trial ID
NCT00405288
Start Date
November 1 2006
End Date
June 1 2010
Last Update
February 5 2014
Active Locations (2)
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1
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
2
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8