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| Name | Class |
|---|---|
| Duchesnay Inc. | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Proctofoam-HC® | Drug | Observational study of the exposure to Proctofoam-HC® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Birth-weight | Weight of the baby measured in grams at time of birth. | until delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Gestational Age at Delivery | Fetal gestational age at delivery | until delivery |
| Mode of Delivery | Method of delivery for both groups: vaginal or caesarean section |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Gideon Koren, MD | The Hospital for Sick Children, Toronto Canada | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mount Sinai Hospital | Toronto | Ontario | M5G 1X5 | Canada | ||
| The Hospital for Sick Children |
There were no significant events that occur before assignment of the enrolled patients to groups.
In this multicentre study we recruited pregnant women who were prescribed Proctofoam-HC for hemorrhoids by their physicians and who completed two telephone interviews using two specially designed questionnaires.
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| ID | Title | Description |
|---|---|---|
| FG000 | Proctofoam-HC® | Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation. |
| FG001 | Control | Control, 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Proctofoam-HC® | Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation. |
| BG001 | Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Birth-weight | Weight of the baby measured in grams at time of birth. | Estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight at a power of 80% and alpha of 5%. Seven pairs of twin pregnancies were excluded from the comparison of birth weight. | Posted | Mean | Standard Deviation | grams | until delivery |
|
The data was collected within the 4 year study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Proctofoam-HC® | Proctofoam-HC® aerosol foam canister for 36 applications. One applicatorful should be injected into the anus (or perianal area) two or three times daily and after bowel evacuation. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gideon Koren | The Hospital for Sick Children | gkoren@sickkids.ca |
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| ID | Term |
|---|---|
| D006484 | Hemorrhoids |
| ID | Term |
|---|---|
| D012002 | Rectal Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C009046 | proctofoam-HC |
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| at birth |
| Prematurity | birth at <37 gestational weeks | at birth |
| Fetal Distress | Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid | at birth |
| Low Birth Weight at Birth | Low birth weight (birth weights <2500 grams) | 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 | at birth |
| Toronto |
| Ontario |
| M5G 1X8 |
| Canada |
Control, 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.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
|
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| Secondary | Gestational Age at Delivery | Fetal gestational age at delivery | Posted | Mean | Standard Deviation | gestational weeks | until delivery |
|
|
|
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| Secondary | Mode of Delivery | Method of delivery for both groups: vaginal or caesarean section | Posted | Number | participants | at birth |
|
|
|
|
| Secondary | Prematurity | birth at <37 gestational weeks | Posted | Number | participants | at birth |
|
|
|
|
| Secondary | Fetal Distress | Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid | Posted | Number | participants | at birth |
|
|
|
|
| Secondary | Low Birth Weight at Birth | Low birth weight (birth weights <2500 grams) | Per protocol, the estimated number of 200 patients per arm, to detect significant difference of 200g in birth weight (primary outcome) for a power of 80% and alpha of 5% was used. | Posted | Number | participants | at birth |
|
|
|
|
| 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 | Posted | Number | participants | at birth |
|
|
|
|
| Post-Hoc | Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth | Assessment of neonate's morphology and function of cardiovascular system in the first two weeks after birth | Posted | Number | participants | neonatal period |
|
|
|
|
| Post-Hoc | Respiratory Neonatal Health Concerns | Posted | Number | participants | neonatal period |
|
|
|
|
| Post-Hoc | Neonatal Health Concerns-infections | Infections occuring in the neonatal period | Posted | Number | participants | neonatal period |
|
|
|
|
| Post-Hoc | Skin Conditions in Neonatal Period | Posted | Number | participants | neonatal period |
|
|
|
|
| Post-Hoc | Other Neonatal Health Concerns | Posted | Number | participants | neonatal period |
|
|
|
| 0 |
| 204 |
| 0 |
| 204 |
| EG001 | Control | Control, 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. | 0 | 204 | 0 | 204 |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| Unknown |
|
| Premature atrial contraction |
|
| Tachypnea |
|
| Pneumonia |
|
| Leucocytosis |
|
| Acne |
|
| Colic |
|
| Milk allergy |
|
| Hypoglycemia |
|
| Poor feeding |
|
| Poor weight gain |
|
| Anemia |
|
| Renal calculi |
|