Trial Outcomes & Findings for The Safety of Proctofoam-HC in the Third Trimester of Pregnancy (NCT NCT00405288)

NCT ID: NCT00405288

Last Updated: 2014-02-05

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 408 participants
• Primary outcome timeframe: until delivery
• Results posted on: 2014-02-05

Participant Flow

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.

There were no significant events that occur before assignment of the enrolled patients to groups.

Participant milestones

Measure	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.	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.
Overall Study STARTED	204	204
Overall Study COMPLETED	204	204
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Proctofoam-HC® n=204 Participants 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 n=204 Participants 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 n=408 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	204 Participants n=5 Participants	204 Participants n=7 Participants	408 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32 years STANDARD_DEVIATION 4.9 • n=5 Participants	31.5 years STANDARD_DEVIATION 4.9 • n=7 Participants	31.75 years STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male Female	204 Participants n=5 Participants	204 Participants n=7 Participants	408 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Canada	204 participants n=5 Participants	204 participants n=7 Participants	408 participants n=5 Participants

PRIMARY outcome

Timeframe: until delivery

Population: 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.

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

Outcome measures

Measure	Proctofoam-HC® n=201 Participants 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 n=201 Participants 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.
Birth-weight	3406.9 grams Standard Deviation 452.7	3487.7 grams Standard Deviation 491.4

SECONDARY outcome

Timeframe: until delivery

Fetal gestational age at delivery

Outcome measures

Measure	Proctofoam-HC® n=204 Participants 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 n=194 Participants 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.
Gestational Age at Delivery	39.4 gestational weeks Standard Deviation 1.4	39.1 gestational weeks Standard Deviation 2.5

SECONDARY outcome

Timeframe: at birth

Method of delivery for both groups: vaginal or caesarean section

Outcome measures

Measure	Proctofoam-HC® n=204 Participants 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 n=204 Participants 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.
Mode of Delivery Unknown	0 participants	3 participants
Mode of Delivery Vaginal delivery	173 participants	146 participants
Mode of Delivery Caesarean section	31 participants	55 participants

SECONDARY outcome

Timeframe: at birth

birth at <37 gestational weeks

Outcome measures

Measure	Proctofoam-HC® n=201 Participants 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 n=190 Participants 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.
Prematurity yes	8 participants	10 participants
Prematurity no	193 participants	180 participants

SECONDARY outcome

Timeframe: at birth

Presence of fetal distress at birth: heart deceleration/acceleration, meconium/amniotic fluid

Outcome measures

Measure	Proctofoam-HC® n=199 Participants 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 n=173 Participants 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.
Fetal Distress Fetal distress	36 participants	31 participants
Fetal Distress No fetal distress	163 participants	142 participants

SECONDARY outcome

Timeframe: at birth

Population: 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.

Low birth weight (birth weights <2500 grams)

Outcome measures

Measure	Proctofoam-HC® n=200 Participants 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 n=201 Participants 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.
Low Birth Weight at Birth Yes	6 participants	3 participants
Low Birth Weight at Birth No	194 participants	198 participants

SECONDARY outcome

Timeframe: at birth

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

Outcome measures

Measure	Proctofoam-HC® n=199 Participants 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 n=199 Participants 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.
Neonatal Health Yes (present neonatal health concerns)	28 participants	24 participants
Neonatal Health No (absent neonatal health concerns)	171 participants	154 participants

POST_HOC outcome

Timeframe: neonatal period

Assessment of neonate's morphology and function of cardiovascular system in the first two weeks after birth

Outcome measures

Measure	Proctofoam-HC® n=199 Participants 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 n=179 Participants 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.
Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth Cardiovascular anomalies	2 participants	0 participants
Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth Heart murmur	6 participants	4 participants
Cardiovascular Neonatal Health Concerns in the First Two Weeks After Birth Premature atrial contraction	0 participants	2 participants

POST_HOC outcome

Timeframe: neonatal period

Outcome measures

Measure	Proctofoam-HC® n=199 Participants 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 n=178 Participants 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.
Respiratory Neonatal Health Concerns Pulmonary aspiration	4 participants	0 participants
Respiratory Neonatal Health Concerns Mild asthma	2 participants	2 participants
Respiratory Neonatal Health Concerns Tachypnea	0 participants	2 participants

POST_HOC outcome

Timeframe: neonatal period

Infections occuring in the neonatal period

Outcome measures

Measure	Proctofoam-HC® n=199 Participants 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 n=178 Participants 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.
Neonatal Health Concerns-infections Urinary tract infections	2 participants	0 participants
Neonatal Health Concerns-infections Streptococcus B infection	0 participants	2 participants
Neonatal Health Concerns-infections Pneumonia	0 participants	2 participants
Neonatal Health Concerns-infections Leucocytosis	2 participants	0 participants

POST_HOC outcome

Timeframe: neonatal period

Outcome measures

Measure	Proctofoam-HC® n=199 Participants 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 n=178 Participants 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.
Skin Conditions in Neonatal Period Rash	2 participants	2 participants
Skin Conditions in Neonatal Period Eczema	0 participants	2 participants
Skin Conditions in Neonatal Period Acne	0 participants	2 participants

POST_HOC outcome

Timeframe: neonatal period

Outcome measures

Measure	Proctofoam-HC® n=199 Participants 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 n=178 Participants 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.
Other Neonatal Health Concerns Poor feeding	2 participants	0 participants
Other Neonatal Health Concerns Poor weight gain	2 participants	2 participants
Other Neonatal Health Concerns Anemia	0 participants	2 participants
Other Neonatal Health Concerns Renal calculi	0 participants	2 participants
Other Neonatal Health Concerns Conjuctivitis	4 participants	0 participants
Other Neonatal Health Concerns Myopia	0 participants	2 participants
Other Neonatal Health Concerns Colic	0 participants	4 participants
Other Neonatal Health Concerns Milk allergy	0 participants	2 participants
Other Neonatal Health Concerns Hypoglycemia	4 participants	0 participants

Adverse Events

Proctofoam-HC®

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Gideon Koren

The Hospital for Sick Children

Email: gkoren@sickkids.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place