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

The Hospital for Sick Children408 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

408

Conditions

Hemorrhoids Pregnancy

Interventions

Proctofoam-HC®DRUG

Observational study of the exposure to Proctofoam-HC®

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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)

Locations (2)

Mount Sinai Hospital

Toronto, Ontario, Canada

The Hospital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Birth-weight

Weight of the baby measured in grams at time of birth.

Time frame: until delivery

Secondary Outcomes

Gestational Age at Delivery

Fetal gestational age at delivery

Time frame: until delivery

Mode of Delivery

Method of delivery for both groups: vaginal or caesarean section

Time frame: at birth

Prematurity

birth at \<37 gestational weeks

Time frame: at birth

Fetal Distress

Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid

Time frame: at birth

Low Birth Weight at Birth

Low birth weight (birth weights \<2500 grams)

Time frame: 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

Time frame: at birth

Data from ClinicalTrials.gov

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