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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00405288
• Other study ID #: 1000008482
• Status: Completed
• Phase: Phase 4
• First received: November 28, 2006
• Last updated: January 3, 2014
• Start date: November 2006
• Est. completion date: June 2010

Study information

• Verified date: January 2014
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: June 2010
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hemorrhoids
• Pregnancy

Intervention

Drug:
• Proctofoam-HC®
Observational study of the exposure to Proctofoam-HC®

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
The Hospital for Sick Children	Duchesnay Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Birth-weight	Weight of the baby measured in grams at time of birth.	until delivery	Yes
Secondary	Gestational Age at Delivery	Fetal gestational age at delivery	until delivery	Yes
Secondary	Mode of Delivery	Method of delivery for both groups: vaginal or caesarean section	at birth	No
Secondary	Prematurity	birth at <37 gestational weeks	at birth	Yes
Secondary	Fetal Distress	Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid	at birth	Yes
Secondary	Low Birth Weight at Birth	Low birth weight (birth weights <2500 grams)	at birth	Yes
Secondary	Neonatal Health	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	Yes