Gynuity Instuctions for use: Misoprostol for Treatment of Incomplete Abortion and Miscarriage

Publication date: 2004

A INSTRUCTIONS FOR USE MISOPROSTOL FOR TREATMENT OF INCOMPLETE ABORTION AND MISCARRIAGE BACKGROUND Misoprostol is a prostaglandin E1 analog generally registered for prevention and treatment of gastric ulcers resulting from chronic administration of nonsteroidal anti-inflammatory drugs (NSAIDs). As misoprostol also induces uterine contractions, it is commonly used off-label for treatment of early pregnancy failures including incomplete and missed abortions. Studies have demonstrated that misoprostol can be used effectively and safely for these indications. This information is presented for the guidance of trained healthcare providers. INDICATION AND USAGE Misoprostol is indicated for treatment of incomplete abortion and miscarriage for women with uterine size less than or equal to 12 weeks LMP at presentation. Use of misoprostol for incomplete abortion has a success rate of 66 -100% using the recommended dose. Use of misoprostol for missed abortion has a success rate of 60-93% using the recommended dose. CONTRAINDICATIONS 1. History of allergy to misoprostol or other prostaglandin 2. Suspicion of ectopic pregnancy 3. Signs of pelvic infection and/or sepsis 4. Symptoms of hemodynamic instability or shock PRECAUTIONS 1. Women eligible for misoprostol, but with an IUD in place, should have the IUD removed before drug administration. 2. Caution is advised when treating women with known bleeding disorders or currently taking anti-coagulants. 3. Misoprostol may be used with caution in patients with uterine size larger than 12 weeks LMP but with a known gestational age less than or equal to 12 weeks (e.g. uterine enlargement due to fibroids). 4. Small amounts of misoprostol or its active metabolite may appear in breast milk. There are no known consequences of this and no adverse effects on nursing infants have been reported. EFFECTS AND SIDE EFFECTS Prolonged or serious effects and side effects are rare. 1. BLEEDING After administration of misoprostol, bleeding typically lasts up to two weeks with additional days of spotting that can last until the next menstrual period. The woman should be instructed to contact a provider if any of the following occur: (1) if she soaks more than two extra large sanitary pads an hour for more than two consecutive hours, (2) if she suddenly experiences heavy bleeding after bleeding has slowed or stopped for several days, (3) if she has bled continuously for several weeks and begins to feel dizzy or light-headed. 2. CRAMPING Cramping usually starts within the first few hours and may begin as early as 30 minutes after misoprostol administration. The pain may be stronger than that experienced during a regular period. Nonsteroidal anti- inflammatory drugs (NSAIDs) or other analgesia can be used for pain relief without affecting the success of the method. 3. FEVER AND/OR CHILLS Chills are a common side effect of misoprostol but are transient. Fever is less common and does not necessarily indicate infection. An antipyretic can be used for relief of fever, if needed. If fever or chills persist beyond 24 hours after taking misoprostol, the woman may have an infection and should seek medical attention. 4. NAUSEA AND VOMITING Nausea and vomiting may occur and will resolve 2 to 6 hours after taking misoprostol. An antiemetic can be used if needed. 5. DIARRHEA Diarrhea may also occur following administration of misoprostol but should resolve within a day. DOSAGE AND ADMINISTRATION Incomplete abortion: The recommended regimen for treatment of incomplete abortion with misoprostol is a single dose of 600 mcg misoprostol orally. Missed abortion: In the instance where diagnosis of missed abortion is certain and/or the cervix is firmly closed, the recommended regimen is a single dose of 800 mcg misoprostol vaginally. Highest success rates are achieved with extended follow-up (7 to 14 days) to allow completion of expulsion. Surgical intervention is not recommended prior to 7 days after treatment unless medically necessary. Notes: • There is also evidence that a repeated dose may increase efficacy. • Misoprostol probably also works well when placed between the cheek and gum (buccally) or under the tongue (sublingually). Suggested Citation: Consensus Statement: Instructions for Use – Misoprostol for Treatment of Incomplete Abortion and Miscarriage. Expert Meeting on Misoprostol sponsored by Reproductive Health Technologies Project and Gynuity Health Projects. June 9, 2004. New York, NY. For a reference list of literature supporting this document or for more information, refer to www.gynuity.org or www.rhtp.org. THIS DOCUMENT WILL BE PERIODICALLY REVIEWED AND UPDATED WITH CURRENT INFORMATION AND RESEARCH DEVELOPMENTS. © 2004 Gynuity Health Projects and Reproductive Health Technologies Project 11/23/04 Background Indication and Usage Contraindications 1. History of allergy to misoprostol or other prostaglandin Precautions 1. Women eligible for misoprostol, but with an IUD in place 2. Caution is advised when treating women with known bleedi 3. Misoprostol may be used with caution in patients with ut 4. Small amounts of misoprostol or its active metabolite ma Effects and Side Effects Dosage and Administration

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