The fetal safety of hydrocortisone-pramoxine (Proctofoam-HC) for the treatment of hemorrhoids in late pregnancy.

OBJECTIVE: Fetal safety has never been studied for any drug used in the treatment of hemorrhoids. Proctofoam-HC is a combination of a corticosteroid and a local anaesthetic that is proven effective for the treatment of hemorrhoids. The objective of this study was to assess prospectively the fetal safety of third trimester exposure to Proctofoam-HC. METHODS: In a multicentre study, 204 [corrected] women exposed to Proctofoam-HC in the third trimester and a similar number of control pregnant women were followed up postnatally. RESULTS: When compared to controls exposure to Proctofoam-HC was not associated with any adverse fetal effects on birth weight, gestational age, rates of prematurity, or pre- or postnatal complications. CONCLUSION: Proctofoam-HC is safe to use in the treatment of hemorrhoids in late pregnancy.

The effectiveness of Proctofoam-HC for treatment of hemorrhoids in late pregnancy.

OBJECTIVE: Currently no topical anti-hemorrhoidal agents have been studied for effectiveness in pregnancy. This study evaluated the effectiveness of Proctofoam-HC used during the last trimester of pregnancy. METHODS: In this prospective, open-label, observational study, pregnant women prescribed Proctofoam-HC were asked to complete two telephone interview questionnaires. RESULTS: A total of 88 women completed the study. All hemorrhoidal symptoms, including pain, pruritus, swelling, itching, decreased significantly (P < 0.001) and overall well-being improved. The improvement was clinically very significant after correction for potential placebo effect. CONCLUSIONS: Proctofoam-HC appears to provide effective treatment of hemorrhoids in late pregnancy.

A randomized cross over trial of tolerability and compliance of a micronutrient supplement with low iron separated from calcium vs high iron combined with calcium in pregnant women [ISRCTN56071145].

BACKGROUND: Prenatal micronutrient combinations with high iron content are associated with high rates of gastrointestinal symptoms. This coupled with nausea and vomiting of pregnancy results in women often discontinuing their multivitamins. A new prescription supplement (PregVit) that separates iron from calcium in two tablets--morning and evening, has lower elemental iron content (35 mg), but results in similar extent of iron absorption when compared to another supplement containing (60 mg) of elemental iron (Materna). The objectives of this study were to compare tolerability and compliance with PregVit vs. a supplement with high iron content (Materna), in pregnant women. METHODS: Randomized, crossover open labeled study in 135 pregnant women attending outpatient clinics in Ontario and Quebec. RESULTS: Use of PregVit was associated with a 30% reduction in constipation rate as compared to Materna. Both products demonstrated similar compliance rates. Compliance of Materna was negatively associated with the severity of nausea and vomiting of pregnancy. No such correlation was found for PregVvit. CONCLUSION: PregVit, a supplement with lower iron content (35 mg), has significantly decreased constipation rates as compared to 60 mg iron--Materna and has similar compliance rates. High iron content in multivitamin supplements is associated with adverse effects in pregnancy.