Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion

Study Overview
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Brief Summary
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The purpose of this study is to compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.

Detailed Description
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Primary outcome: Incidence of complete miscarriage (complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol) Secondary outcome: Need for surgical evacuation of the products of conception Incomplete expulsion of the products of conception (incomplete miscarriage). Considerable bleeding necessitating immediate surgical evacuation. Maternal morbidity Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion) Minor side effects (fever, rigors, nausea, vomiting) Patient's compliance and adherence to treatment Hemoglobin and hematocrit deficit

Official Title
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Use of Letrozole Pretreatment With Misoprostol for First-Trimester Medical Abortion: Randomised Controlled Trial

Conditions
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Complete Miscarriage

Intervention / Treatment
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* Drug: Letrozole
* Drug: Misoprostol
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Maternal age more than 18 years old (age of legal consent). Gestational age less than 13 weeks. Hemoglobin >10 g/dL. BMI between 25 kg/m2 and 35 kg/m2. Missed abortion. Living fetus with multiple congenital malformations incompatible with life. Exclusion Criteria: Maternal age less than 18 years old. Gestational age more than 12 weeks. Hemoglobin <10 g/dL. Anencephaly. Fibroid uterus. BMI less than 25kg/m2 and more than 35kg/m2. Coagulopathy. History or evidence of adrenal pathology. Previous attempts for induction of abortion in the current pregnancy. Allergy to misoprostol or letrozole. Medical disorder that contraindicate induction of abortion (e.g. heart failure).

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: letrozole<br>Women will receive three tablets of letrozole(FemaraR, NOVARTIS) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses. | Drug: Letrozole<br> <br> * Other names: femara;Drug: Misoprostol<br> <br> * Other names: Misotac; Misotec; Cytotec;|
| Placebo Comparator: placebo<br>Women will receive three tablets of placebo as a single dose, for two days at home and will be told to bring back the empty packs. The third dose will be given on admission to hospital on day three and will be followed by 4 tablets of vaginal misoprostol (200 mcg) (MisotacR,SIGMA)soaked with saline every three hours up to maximum 2 doses. | Drug: Misoprostol<br> <br> * Other names: Misotac; Misotec; Cytotec;Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complete abortion | complete expulsion of the products of conception with no need for surgical intervention within one week from the first dose of misoprostol | 1 week | 

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 Incomplete expulsion of the products of conception (incomplete miscarriage). Considerable bleeding necessitating immediate surgical evacuation. | 1 week | 
| Maternal morbidity | Maternal morbidity Major side effects (Sepsis, considerable vaginal bleeding leading to hemodynamic instability or necessitating blood transfusion) Minor side effects (fever, rigors, nausea, vomiting) | 1 week | 
| Hemoglobin and hematocrit deficit |  | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Letrozole, Misoprostol, First-Trimester, Pretreatment