NCT00405288

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
408

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2006

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

November 28, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 30, 2006

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

February 5, 2014

Completed
Last Updated

February 5, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

November 28, 2006

Results QC Date

August 16, 2013

Last Update Submit

January 3, 2014

Conditions

HemorrhoidsPregnancy

Keywords

HemorrhoidsPregnancyantihemorrhoidalProctofoaminfants

Outcome Measures

Primary Outcomes (1)

  • Birth-weight

    Weight of the baby measured in grams at time of birth.

    until delivery

Secondary Outcomes (6)

  • Gestational Age at Delivery

    until delivery

  • Mode of Delivery

    at birth

  • Prematurity

    at birth

  • Fetal Distress

    at birth

  • Low Birth Weight at Birth

    at birth

  • +1 more secondary outcomes

Study Arms (2)

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®

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.

Interventions

Proctofoam-HC®DRUG

Observational study of the exposure to Proctofoam-HC®

Also known as: 1% Pramoxine+1% Hydrocortisone ( Proctofoam-HC®)
Proctofoam-HC®

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Hemorrhoids

Interventions

proctofoam-HC

Condition Hierarchy (Ancestors)

Rectal DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesVascular DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. Gideon Koren
Organization
The Hospital for Sick Children
gkoren@sickkids.ca

Study Officials

  • Gideon Koren, MD

    The Hospital for Sick Children, Toronto Canada

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief, Global Child Health

Study Record Dates

First Submitted

November 28, 2006

First Posted

November 30, 2006

Study Start

November 1, 2006

Primary Completion

November 1, 2009

Study Completion

June 1, 2010

Last Updated

February 5, 2014

Results First Posted

February 5, 2014

Record last verified: 2014-01

Locations

CA(2)