N/A
N=408
The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
Hemorrhoids · Pregnancy
Bottom Line
View on ClinicalTrials.gov: NCT00405288 ↗Enrolled (actual)
408
Serious AEs
0.0%
Results posted
Feb 2014
Primary outcome: Primary: Birth-weight — 3406.9; 3487.7 grams — p=0.17
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- Proctofoam-HC® (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- The Hospital for Sick Children
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Birth-weight |
3406.9; 3487.7 | 0.17 |
| SECONDARY Gestational Age at Delivery |
39.4; 39.1 | 0.16 |
| SECONDARY Mode of Delivery |
173; 146; 31; 55; 0; 3 | 0.003 sig |
| SECONDARY Prematurity |
8; 10; 193; 180 | 0.55 |
| SECONDARY Fetal Distress |
36; 31; 163; 142 | 0.97 |
| SECONDARY Low Birth Weight at Birth |
6; 3; 194; 198 | 0.31 |
| SECONDARY Neonatal Health |
28; 24; 171; 154 | 0.87 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
Data sourced from ClinicalTrials.gov (NCT00405288). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.