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

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ClinicalTrials.gov Identifier: NCT00405288
Recruitment Status : Completed
First Posted : November 30, 2006
Results First Posted : February 5, 2014
Last Update Posted : February 5, 2014
Sponsor:
Collaborator:
Duchesnay Inc.
Information provided by (Responsible Party):
Gideon Koren, The Hospital for Sick Children

Study Type Observational
Study Design Observational Model: Case Control;   Time Perspective: Prospective
Conditions Hemorrhoids
Pregnancy
Intervention Drug: Proctofoam-HC®
Enrollment 408
Recruitment Details 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.
Pre-assignment Details There were no significant events that occur before assignment of the enrolled patients to groups.
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description 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. 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.
Period Title: Overall Study
Started 204 204
Completed 204 204
Not Completed 0 0
Arm/Group Title Proctofoam-HC® Control Total
Hide Arm/Group Description 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 204 204 408
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants 204 participants 408 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
204
 100.0%
204
 100.0%
408
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 204 participants 204 participants 408 participants
32  (4.9) 31.5  (4.9) 31.75  (4.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 204 participants 204 participants 408 participants
Female
204
 100.0%
204
 100.0%
408
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 204 participants 204 participants 408 participants
204 204 408
1.Primary Outcome
Title Birth-weight
Hide Description Weight of the baby measured in grams at time of birth.
Time Frame until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 201 201
Mean (Standard Deviation)
Unit of Measure: grams
3406.9  (452.7) 3487.7  (491.4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments

Null hypothesis: Birth weight in pregnancies exposed to Proctofoam-HC will be the same as control pregnancies.

To detect a clinically significant decrease of 200 g in birth weight at a power of 80% and alpha of 5%, 200 women per group were required. Post hoc power analysis of our cohort revealed that, in fact, we had a 91.5% power to detect a 200 g difference in birth weight between the two groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 50
Confidence Interval (2-Sided) 95%
0 to 200
Parameter Dispersion
Type: Standard Deviation
Value: 450
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Gestational Age at Delivery
Hide Description Fetal gestational age at delivery
Time Frame until delivery
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 204 194
Mean (Standard Deviation)
Unit of Measure: gestational weeks
39.4  (1.4) 39.1  (2.5)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.16
Comments [Not Specified]
Method Wilcoxon (Mann-Whitney)
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 1
Confidence Interval (2-Sided) 95%
0 to 3
Parameter Dispersion
Type: Standard Deviation
Value: 3
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Mode of Delivery
Hide Description Method of delivery for both groups: vaginal or caesarean section
Time Frame at birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 204 204
Measure Type: Number
Unit of Measure: participants
Vaginal delivery 173 146
Caesarean section 31 55
Unknown 0 3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments The null hypothesis is that the proportion of vaginal deliveries in the Proctofoam and Control groups will be the same (ie. there will not be a greater proportion of complicated deliveries in either group).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter chi square
Estimated Value 30
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Prematurity
Hide Description birth at <37 gestational weeks
Time Frame at birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 201 190
Measure Type: Number
Unit of Measure: participants
yes 8 10
no 193 180
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments The null hypothesis is that the proportion of pre-term births in the Proctofoam and Control groups will be the same.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter chi square
Estimated Value 5
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Fetal Distress
Hide Description Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid
Time Frame at birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 199 173
Measure Type: Number
Unit of Measure: participants
Fetal distress 36 31
No fetal distress 163 142
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments Fetal Distress The null hypothesis is that the proportion of fetal distress in the Proctofoam and Control groups will be the same.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter chi square
Estimated Value 10
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Low Birth Weight at Birth
Hide Description Low birth weight (birth weights <2500 grams)
Time Frame at birth
Hide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 200 201
Measure Type: Number
Unit of Measure: participants
Yes 6 3
No 194 198
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments Low birth weight <2,500g; The null hypothesis is that the proportion of low birth weight babies in the Proctofoam and Control groups will be the same.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.31
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter binary
Estimated Value 3
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Neonatal Health
Hide Description 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
Time Frame at birth
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 199 199
Measure Type: Number
Unit of Measure: participants
Yes (present neonatal health concerns) 28 24
No (absent neonatal health concerns) 171 154
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments The null hypothesis is that the proportion of healthy babies (not requiring NICU (neonatal intensive care unit) or additional medical monitoring) will be the same between the Proctofoam and Control groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.87
Comments [Not Specified]
Method McNemar
Comments [Not Specified]
Method of Estimation Estimation Parameter chi square
Estimated Value 10
Estimation Comments [Not Specified]
8.Post-Hoc Outcome
Title Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth
Hide Description Assessment of neonate's morphology and function of cardiovascular system in the first two weeks after birth
Time Frame neonatal period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 199 179
Measure Type: Number
Unit of Measure: participants
Cardiovascular anomalies 2 0
Heart murmur 6 4
Premature atrial contraction 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value 4
Estimation Comments [Not Specified]
9.Post-Hoc Outcome
Title Respiratory Neonatal Health Concerns
Hide Description [Not Specified]
Time Frame neonatal period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 199 178
Measure Type: Number
Unit of Measure: participants
Pulmonary aspiration 4 0
Mild asthma 2 2
Tachypnea 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value 3
Estimation Comments [Not Specified]
10.Post-Hoc Outcome
Title Neonatal Health Concerns-infections
Hide Description Infections occuring in the neonatal period
Time Frame neonatal period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 199 178
Measure Type: Number
Unit of Measure: participants
Urinary tract infections 2 0
Streptococcus B infection 0 2
Pneumonia 0 2
Leucocytosis 2 0
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.99
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter proportion
Estimated Value 2
Estimation Comments [Not Specified]
11.Post-Hoc Outcome
Title Skin Conditions in Neonatal Period
Hide Description [Not Specified]
Time Frame neonatal period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 199 178
Measure Type: Number
Unit of Measure: participants
Rash 2 2
Eczema 0 2
Acne 0 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Proctofoam-HC®, Control
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.35
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Method of Estimation Estimation Parameter proportions
Estimated Value 2
Estimation Comments [Not Specified]
12.Post-Hoc Outcome
Title Other Neonatal Health Concerns
Hide Description [Not Specified]
Time Frame neonatal period
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 199 178
Measure Type: Number
Unit of Measure: participants
Conjuctivitis 4 0
Myopia 0 2
Colic 0 4
Milk allergy 0 2
Hypoglycemia 4 0
Poor feeding 2 0
Poor weight gain 2 2
Anemia 0 2
Renal calculi 0 2
Time Frame The data was collected within the 4 year study period.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Proctofoam-HC® Control
Hide Arm/Group Description 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. 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.
All-Cause Mortality
Proctofoam-HC® Control
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Proctofoam-HC® Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/204 (0.00%)   0/204 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Proctofoam-HC® Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/204 (0.00%)   0/204 (0.00%) 
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Gideon Koren
Organization: The Hospital for Sick Children
EMail: gkoren@sickkids.ca
Layout table for additonal information
Responsible Party: Gideon Koren, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT00405288     History of Changes
Other Study ID Numbers: 1000008482
First Submitted: November 28, 2006
First Posted: November 30, 2006
Results First Submitted: August 16, 2013
Results First Posted: February 5, 2014
Last Update Posted: February 5, 2014