Letrozole Pretreatment With Misoprostol Induction 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 among women with one or more previous cesarean deliveries.

Official Title
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Letrozole Pretreatment With Misoprostol for Induction of Abortion In First-Trimester Missed Miscarriage Among Women With One or More Previous Cesarean Deliveries.: 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. previous one or more cesarean delivaries 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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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>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 then misoprostol<br>* Drug: Letrozole 2.5mg total dose 7.5 mg per day for 3 days Drug: Misoprostol 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 then misoprostol<br>* Drug: Placebo placebo for 3 days Drug: Misoprostol 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 |
| --- | --- | --- |
| induction to abortion time | induction to abortion time | 6 hours | 
| Incidence of complete miscarriage | Incidence of complete miscarriage | 6 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for surgical evacuation of the products of conception | Need for surgical evacuation of the products of conception | 6 hours |