The Safety of Proctofoam-HC in the Third Trimester of Pregnancy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 408
- 试验地点
- 2
- 主要终点
- Birth-weight
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
研究组 & 干预措施
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.
干预措施: Proctofoam-HC® (Drug)
结局指标
主要结局
Birth-weight
时间窗: until delivery
Weight of the baby measured in grams at time of birth.
次要结局
- Fetal Distress(at birth)
- Gestational Age at Delivery(until delivery)
- Prematurity(at birth)
- Mode of Delivery(at birth)
- Low Birth Weight at Birth(at birth)
- Neonatal Health(at birth)
研究者
Gideon Koren
Chief, Global Child Health
The Hospital for Sick Children