We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00405288
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Information provided by (Responsible Party):

November 28, 2006
November 30, 2006
August 16, 2013
February 5, 2014
February 5, 2014
November 2006
November 2009   (Final data collection date for primary outcome measure)
Birth-weight [ Time Frame: until delivery ]
Weight of the baby measured in grams at time of birth.
Complete list of historical versions of study NCT00405288 on ClinicalTrials.gov Archive Site
  • Gestational Age at Delivery [ Time Frame: until delivery ]
    Fetal gestational age at delivery
  • Mode of Delivery [ Time Frame: at birth ]
    Method of delivery for both groups: vaginal or caesarean section
  • Prematurity [ Time Frame: at birth ]
    birth at <37 gestational weeks
  • Fetal Distress [ Time Frame: at birth ]
    Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid
  • Low Birth Weight at Birth [ Time Frame: at birth ]
    Low birth weight (birth weights <2500 grams)
  • Neonatal Health [ Time Frame: 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
  • Child developmental milestones at approximately 6 months post-delivery
  • Child anthropometric data at approximately 6 months post-delivery
Not Provided
Not Provided
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
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.

Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Probability Sample
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
  • Hemorrhoids
  • Pregnancy
Drug: Proctofoam-HC®
Observational study of the exposure to Proctofoam-HC®
Other Name: 1% Pramoxine+1% Hydrocortisone ( 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.
    Intervention: Drug: Proctofoam-HC®
  • Control
    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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
June 2010
November 2009   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
Gideon Koren, The Hospital for Sick Children
The Hospital for Sick Children
Duchesnay Inc.
Principal Investigator: Gideon Koren, MD The Hospital for Sick Children, Toronto Canada
The Hospital for Sick Children
January 2014