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

NCT ID: NCT00405288

Last Updated: 2014-02-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 408 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-11-30
• Study Completion Date: 2010-06-30

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 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Proctofoam-HC®

Women in the third trimester of pregnancy prescribed Proctofoam-HC® aerosol foam canister for 36 applications for treatment of symptoms of hemorrhoids. One applicatorful is to be applied into the anus (or on the perianal area) two or three times daily and after bowel evacuation.

Proctofoam-HC®

Intervention Type: DRUG

Observational study of the exposure to Proctofoam-HC®

Control

Control group of women in the third trimester of pregnancy 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.

No interventions assigned to this group

Interventions

Proctofoam-HC®

Observational study of the exposure to Proctofoam-HC®

Intervention Type: DRUG

Other Intervention Names

1% Pramoxine+1% Hydrocortisone ( Proctofoam-HC®)

Eligibility 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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Duchesnay Inc.

INDUSTRY

Sponsor Role: collaborator

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Gideon Koren

Chief, Global Child Health

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gideon Koren, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children, Toronto Canada

Locations

Mount Sinai Hospital

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000008482

Identifier Type: -

Identifier Source: org_study_id