HemorrhoidsNCT00405288
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
An observational study of Hemorrhoids and Pregnancy, run by The Hospital for Sick Children at 2 sites in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hemorrhoids, Pregnancy
- What is being tested?
- Proctofoam-HC®
- How many people
- 408 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2006to Jun 2010
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
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- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Mount Sinai Hospital
Toronto, Ontario, M5G 1X5
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
About this study
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.
Read the 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.
- Conditions
- Hemorrhoids, Pregnancy
- Being tested
- Proctofoam-HC®
- Keywords
- Hemorrhoids, Pregnancy, antihemorrhoidal, Proctofoam, infants
- Medical subject headings
- Hemorrhoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proctofoam-HC®Drug
Also called 1% Pramoxine+1% Hydrocortisone ( Proctofoam-HC®)
Observational study of the exposure to Proctofoam-HC®
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth-weight
Weight of the baby measured in grams at time of birth.
Measured: until delivery
Secondary outcomes (6)
Gestational Age at Delivery
Fetal gestational age at delivery
Measured: until delivery
Mode of Delivery
Method of delivery for both groups: vaginal or caesarean section
Measured: at birth
Prematurity
birth at <37 gestational weeks
Measured: at birth
Fetal Distress
Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid
Measured: at birth
Low Birth Weight at Birth
Low birth weight (birth weights <2500 grams)
Measured: at birth
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
Measured: at birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2006 (estimated)
- Study startNov 2006
- Primary completionNov 2009
- Study completionJun 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HemorrhoidsStudies of the same condition, open and under way.
- More trials run by The Hospital for Sick ChildrenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Hospital for Sick Children
- Sponsor type
- University, hospital or other
- Collaborators
- Duchesnay Inc.
- Responsible party
- Principal investigator, Gideon Koren, The Hospital for Sick Children
- Investigators
- Gideon Koren, MD, Principal investigator, The Hospital for Sick Children, Toronto Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00405288
- Sponsor's protocol ID
- 1000008482
- Status last verified
- Jan 2014
- First submitted
- 28 Nov 2006
- Last updated
- 5 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
- ClinicalTrials.gov ID
- NCT00405288
- Acronym / sponsor ID
- 1000008482
- Conditions
- Hemorrhoids, Pregnancy
- Keywords
- Hemorrhoids, Pregnancy, antihemorrhoidal, Proctofoam, infants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- The Hospital for Sick ChildrenUniversity, hospital or other
- Collaborators
- Duchesnay Inc.
- Study start
- Nov 2006
- Primary completion
- Nov 2009 (actual)
- Study completion
- Jun 2010 (actual)
- First posted
- 30 Nov 2006 (estimated)
- Results
- Posted 5 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Proctofoam-HC® | – | Drug: 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. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Proctofoam-HC®Also: 1% Pramoxine+1% Hydrocortisone ( Proctofoam-HC®)Observational study of the exposure to Proctofoam-HC® | Drug | Proctofoam-HC® |
Primary outcome
Birth-weight
Time frame: until delivery
Weight of the baby measured in grams at time of birth.
6 secondary outcomes
Gestational Age at Delivery
Time frame: until delivery
Mode of Delivery
Time frame: at birth
Prematurity
Time frame: at birth
Fetal Distress
Time frame: at birth
Low Birth Weight at Birth
Time frame: at birth
Neonatal Health
Time frame: at birth
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gideon Koren, MD principal investigator
The Hospital for Sick Children, Toronto Canada
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemorrhoids and Pregnancy, run by The Hospital for Sick Children at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Feb 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth-weight (time frame: until delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2014; AzTrials last refreshed its copy on 8 Nov 2026.