Letrozole Pretreatment With Misoprostol fInduction of Abortion In First-Trimester Missed Miscarriage

Study Overview
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Brief Summary
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This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Detailed Description
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According to the American college of obstetricians and gynecologists (2005), medical abortion is an acceptable alternative for surgical procedures in pregnant women with gestational age of less than 49 days based on the last menstrual period Oral or vaginal misoprostol causes complete abortion in almost 85% of cases within seven days before the 12th week letrozole administration with misoprostol raises the rate of complete abortion Hypothesis: In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.

Official Title
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Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage: A Randomized Controlled Trial

Conditions
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Miscarriage, Missed Abortion

Intervention / Treatment
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* Drug: Letrozole 2.5mg
* Drug: Placebo
* Drug: Misoprostol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Gestational age less than 64 days gestation (<9 wks). Hemoglobin >10 g/dL. BMI between 18.5 kg/m2 and 25 kg/m2. Missed abortion. Exclusion Criteria: Molar pregnancy. Fibroid uterus. Uterine anomalies. Coagulopathy. Medical disorder that contraindicate induction of abortion (e.g. heart failure). Previous attempts for induction of abortion in the current pregnancy. Allergy to misoprostol or letrozole.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study group<br>3 tablets of Letrozole 2.5 mg will be given as single daily dose, 7.5 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses. | Drug: Letrozole 2.5mg<br>* total dose 7.5 mg per day for 3 days<br>Drug: Misoprostol<br>* Misoprosrol 800mcg will be given to all patients for induction of abortion<br>|
| Placebo Comparator: Control group<br>three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses | Drug: Placebo<br>* Folic acid for 3 days<br>Drug: Misoprostol<br>* Misoprosrol 800mcg will be given to all patients for induction of abortion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete miscarriage |  | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for surgical evacuation of the products of conception |  | 6 hours | 
| Incidence of Septic Abortion |  | 1 week |