Clinical trial NCT00405288: The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
Official title: The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemorrhoids
Pregnancy
Keywords: Hemorrhoids
Pregnancy
antihemorrhoidal
Proctofoam
infants
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Duchesnay Inc.
First posted: 2006-11-30
Enrollment: 408
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant woman with a primary anorectal condition during the third trimester of pregnancy and pregnant women in the third trimester of pregnancy without anorectal condition

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.

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)

Primary outcomes:
measure: Birth-weight
timeFrame: until delivery
Secondary outcomes:
measure: Gestational Age at Delivery
timeFrame: until delivery
measure: Mode of Delivery
timeFrame: at birth
measure: Prematurity
timeFrame: at birth
measure: Fetal Distress
timeFrame: at birth
measure: Low Birth Weight at Birth
timeFrame: at birth
measure: Neonatal Health
timeFrame: at birth
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children, Toronto Canada
name: Gideon Koren, MD
role: PRINCIPAL_INVESTIGATOR
References: