Letrozole Pretreatment With Misoprostol Versus Misoprostol Alone in Missed Abortion

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

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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Missed Abortion

Intervention / Treatment
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* Drug: Letrozole then misoprostol
* Drug: placebo then 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. Scared uterus (previous myomectomy, cesarean section, hysterectomy and ruptured uterus).

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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No

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: study group<br>2 tablets of Letrozole 2.5 mg will be given as single daily doses, 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 three doses. | Drug: Letrozole then misoprostol<br>* total dose 5 mg per day for 3 days then Misoprosrol 800mcg will be given to all patients for induction of abortion<br>|
| Placebo Comparator: control group<br>2 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 three doses | Drug: placebo then misoprostol<br>* placebo tablets for 3 days then 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 |
| --- | --- | --- |
| complete abortion rate | Incidence of complete miscarriage | 9 hours | 
| time from induction to abortion | induction to abortion time interval | 9 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for surgical evacuation of the products of conception | how many women will undergo dilatation and curettage after failed medical induction of abortion | 9 hours |