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

January 3, 2014 updated by: Gideon Koren, The Hospital for Sick Children
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

408

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
        • The Hospital for Sick Children
      • Toronto, Ontario, Canada, M5G 1X5
        • Mount Sinai Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Drug: Proctofoam-HC®
Observational study of the exposure to Proctofoam-HC®
Other Names:
  • 1% Pramoxine+1% Hydrocortisone ( 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Duchesnay Inc.

Investigators

  • Principal Investigator: Gideon Koren, MD, The Hospital for Sick Children, Toronto Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

June 1, 2010

Study Registration Dates

First Submitted

November 28, 2006

First Submitted That Met QC Criteria

November 28, 2006

First Posted (Estimate)

November 30, 2006

Study Record Updates

Last Update Posted (Estimate)

February 5, 2014

Last Update Submitted That Met QC Criteria

January 3, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000008482

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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