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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Hemorrhoids, Pregnancy

Intervention / Treatment
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* Drug: Proctofoam-HC®


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control<br>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. | |
| Proctofoam-HC®<br>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. | Drug: Proctofoam-HC®<br>* Observational study of the exposure to Proctofoam-HC®<br>* Other names: 1% Pramoxine+1% Hydrocortisone ( Proctofoam-HC®);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth-weight | Weight of the baby measured in grams at time of birth. | until delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gestational Age at Delivery | Fetal gestational age at delivery | until delivery | 
| Mode of Delivery | Method of delivery for both groups: vaginal or caesarean section | at birth | 
| Prematurity | birth at <37 gestational weeks | at birth | 
| Fetal Distress | Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid | at birth | 
| Low Birth Weight at Birth | Low birth weight (birth weights <2500 grams) | at birth | 
| Neonatal Health | 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 | at birth | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemorrhoids, Pregnancy, antihemorrhoidal, Proctofoam, infants