Can i use proctofoam while pregnant

Save this study. Warning You have reached the maximum number of saved studies The Safety of Proctofoam-HC in the Third Trimester of Pregnancy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U. Federal Government. Read our disclaimer for details. Results First Posted : February 5, Last Update Posted : February 5, Study Description.

Detailed Description:. Drug Information available for: Hydrocortisone acetate Hydrocortisone Hydrocortisone sodium succinate Pramocaine Hydrocortisone cypionate Pramoxine hydrochloride Hydrocortisone valerate Hydrocortisone probutate Proctofoam-HC. FDA Resources. Control group of women in the third trimester of pregnancy 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.

Outcome Measures. Primary Outcome Measures : Birth-weight [ Time Frame: until delivery ] Weight of the baby measured in grams at time of birth. Method of delivery for both groups: vaginal or caesarean section. Eligibility Criteria. Information from the National Library of Medicine Choosing to participate in a study is an important personal decision.

Pregnant woman with a primary anorectal condition during the third trimester of pregnancy and pregnant women in the third trimester of pregnancy without anorectal condition. 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.

Multi fetal pregnancy Binge alcohol consumption 5 or more drinks on one occasion,in a row or within a short period of time. Contacts and Locations. Information from the National Library of Medicine To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials. More Information. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent.

The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention. Stop taking the medication and seek immediate medical attention if any of the following occur:. Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication. Allergies or sensitization: Stop using this medication and call your doctor if irritation, allergic reaction, or sensitization occurs.

Inform all health professionals involved in your care that you have been using corticosteroids. Cautions regarding the container: Contents are flammable and the aerosol container may explode if heated. The contents of the container are under pressure. Do not use in the presence of an open flame or spark and do not place in hot water or near radiators, stoves, or other sources of heat. Diabetes: Hydrocortisone may cause an increase in blood sugar levels may cause a loss of blood glucose control and glucose tolerance may change.

People with diabetes may find it necessary to monitor their blood sugar more frequently while using this medication. If you have diabetes or are at risk for developing diabetes, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Excessive use: Prolonged or excessive use of this product could produce effects similar to those seen after taking corticosteroids by mouth for prolonged periods of time such as thin skin, easy bruising, thin bones, or increased risk of infections.

To minimize this possibility when long-term therapy is anticipated, your doctor may instruct you to periodically interrupt treatment. General precautions: Advise all doctors involved in your care that you have been using this medication. Infected areas: Do not use this medication on infected lesions unless you are also using appropriate anti-infective medications as recommended by your doctor. Infections: Corticosteroids may hide the symptom of new infections and infections may occur more frequently due to the effect corticosteroids have on the immune system.

If you experience skin infections around the affected area or other infections, let your doctor know as soon as possible. Mood changes and mental health: The use of corticosteroids may cause mood swings, a sense of euphoria, depression, or anxiety. If you have a history of mental health concerns, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Ulcerative bowel disease: People with severe ulcerative bowel disease who use rectal hydrocortisone may be at increased risk of perforation of the bowel wall.

If you have ulcerative bowel disease, discuss with your doctor how this medication may affect your medical condition, how your medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed. Pregnancy: This medication should not be used during pregnancy unless the benefits outweigh the risks.

If you become pregnant while using this medication, contact your doctor immediately. Breast-feeding: It is not known if this medication passes into breast milk.

If you are a breast-feeding mother and are using this medication, it may affect your baby. Talk to your doctor about whether you should continue breast-feeding. Children: The safety and effectiveness of using this medication have not been established for children. If you are applying additional medications to the area being treated, speak with your doctor or pharmacist.

If you are taking any of these medications, speak with your doctor or pharmacist. Depending on your specific circumstances, your doctor may want you to:. An interaction between two medications does not always mean that you must stop taking one of them.

Speak to your doctor about how any drug interactions are being managed or should be managed.