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

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ClinicalTrials.gov Identifier: NCT00405288

Recruitment Status : Completed

First Posted : November 30, 2006

Results First Posted : February 5, 2014

Last Update Posted : February 5, 2014

Sponsor:

Collaborator:

Duchesnay Inc.

Information provided by (Responsible Party):

Gideon Koren, The Hospital for Sick Children

Study Description

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.

Condition or disease	Intervention/treatment
Hemorrhoids Pregnancy	Drug: Proctofoam-HC®

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 Design

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Study Type :	Observational
Actual Enrollment :	408 participants
Observational Model:	Case-Control
Time Perspective:	Prospective
Official Title:	The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
Study Start Date :	November 2006
Actual Primary Completion Date :	November 2009
Actual Study Completion Date :	June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemorrhoids Pregnancy

Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Pramocaine Hydrocortisone cypionate Pramoxine hydrochloride Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC

U.S. FDA Resources

Groups and Cohorts

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 Name: 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.

Outcome Measures

Primary Outcome Measures :

Birth-weight [ Time Frame: until delivery ]
Weight of the baby measured in grams at time of birth.

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
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

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)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405288

Locations

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

Sponsors and Collaborators

The Hospital for Sick Children

Duchesnay Inc.

Investigators

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

More Information

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Responsible Party:	Gideon Koren, Chief, Global Child Health, The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00405288
Other Study ID Numbers:	1000008482
First Posted:	November 30, 2006 Key Record Dates
Results First Posted:	February 5, 2014
Last Update Posted:	February 5, 2014
Last Verified:	January 2014

Keywords provided by Gideon Koren, The Hospital for Sick Children:


Hemorrhoids Pregnancy antihemorrhoidal Proctofoam infants

Additional relevant MeSH terms:

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Hemorrhoids Rectal Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases Vascular Diseases Cardiovascular Diseases Hydrocortisone Hydrocortisone 17-butyrate 21-propionate Hydrocortisone acetate	Hydrocortisone hemisuccinate Pramoxine Anti-Inflammatory Agents Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents

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