The Safety of Proctofoam-HC in the Third Trimester of Pregnancy - Full Text View

Sponsor:	The Hospital for Sick Children
Collaborator:	Duchesnay Inc.
Information provided by:	The Hospital for Sick Children
ClinicalTrials.gov Identifier:	NCT00405288

Purpose

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	Intervention	Phase
Hemorrhoids Pregnancy	Drug: Proctofoam-HC®	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	The Safety of Proctofoam-HC in the Third Trimester of Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Hemorrhoids

Drug Information available for: Hydrocortisone acetate Hydrocortisone Proctofoam-HC Hydrocortisone hemisuccinate Hydrocortamate Hydrocortisone 21-sodium succinate Pramocaine Hydrocortisone cypionate Pramoxine hydrochloride Cortisol succinate Cortisol 21-phosphate

U.S. FDA Resources

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:

Birth-weight

Secondary Outcome Measures:

Child developmental milestones at approximately 6 months post-delivery
Child anthropometric data at approximately 6 months post-delivery

Estimated Enrollment:	400
Study Start Date:	November 2006
Estimated Study Completion Date:	November 2009

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00405288

Contacts

Contact: Gideon Koren, MD

416-813-5778

gkoren@sickkids.ca

Locations

Canada, Ontario
The Hospital for Sick Children	Recruiting
Toronto, Ontario, Canada, M5G 1X8
Contact: Gideon Koren, MD 416 813 5778 gkoren@sickkids.ca
Principal Investigator: Gideon Koren, MD
Sub-Investigator: Arthur Staroselsky, MD
Mount Sinai Hospital	Recruiting
Toronto, Ontario, Canada, M5G 1X5
Contact: Paul Bernstein, MD 416-586-4800 ext 5236 pbernstein@mtsinai.on.ca
Principal Investigator: Paul Bernstein, MD

Sponsors and Collaborators

The Hospital for Sick Children

Duchesnay Inc.

Investigators

Principal Investigator:

Gideon Koren, MD

The Hospital for Sick Children, Toronto Canada

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00405288 History of Changes
Other Study ID Numbers:	1000008482
Study First Received:	November 28, 2006
Last Updated:	November 28, 2006
Health Authority:	Canada: Ethics Review Committee

Keywords provided by The Hospital for Sick Children:

Hemorrhoids
Pregnancy
antihemorrhoidal
Proctofoam
infants

Additional relevant MeSH terms:

Hemorrhoids
Rectal Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Vascular Diseases
Cardiovascular Diseases
Cortisol succinate
Hydrocortisone acetate
Hydrocortisone
Pramoxine

Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012