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

Condition(s) targeted: Hemorrhoids; Pregnancy

Intervention: Proctofoam-HC® (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: The Hospital for Sick Children

Official(s) and/or principal investigator(s):
Gideon Koren, MD, Principal Investigator, Affiliation: The Hospital for Sick Children, Toronto Canada

Overall contact:
Gideon Koren, MD, Phone: 416-813-5778, Email: gkoren@sickkids.ca

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.

Official title: The Safety of Proctofoam-HC in the Third Trimester of Pregnancy

Study design: Treatment, Non-Randomized, Open Label, Dose Comparison, Parallel Assignment, Safety Study

Primary outcome: Birth-weight

Secondary outcome:

Child developmental milestones at approximately 6 months post-delivery

Child anthropometric data at approximately 6 months post-delivery

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.

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

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)

Gideon Koren, MD, Phone: 416-813-5778, Email: gkoren@sickkids.ca

The Hospital for Sick Children, Toronto, Ontario M5G 1X8, Canada; Recruiting
Gideon Koren, MD, Phone: 416 813 5778, Email: gkoren@sickkids.ca
Gideon Koren, MD, Principal Investigator
Arthur Staroselsky, MD, Sub-Investigator

Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; Recruiting
Paul Bernstein, MD, Phone: 416-586-4800, Ext: 5236, Email: pbernstein@mtsinai.on.ca
Paul Bernstein, MD, Principal Investigator

Starting date: November 2006
Ending date: November 2009
Last updated: November 28, 2006