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

Completed

• Conditions: Hemorrhoids; Pregnancy
• Interventions: Drug: Proctofoam-HC®

• Registration Number: NCT00405288
• Lead Sponsor: The Hospital for Sick Children

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.

Study Timeline

• Study Start: 2006-11
• Study First Submitted: 2006-11-28
• Study First Submitted QC: 2006-11-28
• Study First Posted: 2006-11-30
• Primary Completion: 2009-11
• Study Completion: 2010-06
• Results First Submitted: 2013-08-16
• Status Verified: 2014-01
• Results First Submitted QC: 2014-01-03
• Last Update Submitted: 2014-01-03
• Results First Posted: 2014-02-05
• Last Update Posted: 2014-02-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 408

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

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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)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Proctofoam-HC®	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.

Primary Outcome Measures

Name	Time	Method
Birth-weight	until delivery	Weight of the baby measured in grams at time of birth.

Secondary Outcome Measures

Name	Time	Method
Fetal Distress	at birth	Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid
Gestational Age at Delivery	until delivery	Fetal gestational age at delivery
Prematurity	at birth	birth at \<37 gestational weeks
Mode of Delivery	at birth	Method of delivery for both groups: vaginal or caesarean section
Low Birth Weight at Birth	at birth	Low birth weight (birth weights \<2500 grams)
Neonatal Health	at birth	Neonatal health at birthyes=need for medical attention or intervention after birth, abnormalities detected, no= no need for medical attention, no abnormalities detected at birth

Trial Locations

Locations (2)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada