Letrozole Pretreatment With Misoprostol Induction of Abortion in First Trimester Missed Abortion

Study Overview
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Brief Summary
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this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.

Detailed Description
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Intervention type: drug Intervention name: letrozole then misoprostol Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion Arm group label:study group Intervention type :drug Intervention name:placebo then misoprostol Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion Arm group label: control group

Official Title
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Use of Letrozole Pretreatment With Misoprostol for Induction of Abortion in First Trimester Missed Abortion

Conditions
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Missed Abortion

Intervention / Treatment
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* Drug: letrozole
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maternal age more than 18 years old. Gestational age less than 13 weeks confirmed by ultrasound scan on day 1 of the study. Hemoglobin >10 g/dl Missed abortion Exclusion Criteria: Mullerian Uterine anomalies as septate, bicornuate uterus. Fibroid uterus. Coagulopathy. Medical disorder that contraindicate induction of abortion. Allergy to misoprostol or letrozole. -

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 42 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
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: letrozole then misoprostol<br>description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed | Drug: letrozole<br>* Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion<br>|
| Placebo Comparator: placebo then misoprostol<br>Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed | Drug: placebo<br>* placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete abortion | incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgical evacuation | surgical evacuation for the remnants of conception among 110 patients in which 55 took letrozole before misoprostol and other 55 patients who took placebo before misoprostol | 6 hours |