Letrozole in Induction of Abortion of Anembryonic Pregnancy

Study Overview
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Brief Summary
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Some studies suggest the prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion. the aim of the study is to compare the effectiveness of various regimens of letrozole combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with blighted ovum.

Detailed Description
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Some studies suggest prescription of aromatase inhibitors prior to the use of misoprostol for inducing drug abortion, increases the efficiency of the treatment regimen and also decreases the need for surgical interventions. Some conducted studies have mentioned reinforcing the impact of misoprostol with letrozole, but reaching the ideal dose still needs more studies, so in this study, the investigators will compare the effectiveness of various regimens of letrozole ( 10 mg/d for 3 days or a single dose of 20 mg) combined with misoprostol versus using misoprostol alone in inducing complete abortion in patients with a blighted ovum.

Official Title
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Letrozole Plus Misoprostol Versus Misoprostol Alone in Induction of Abortion of Anembryonic Pregnancy:

Conditions
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Anembryonic Pregnancy

Intervention / Treatment
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* Drug: Letrozole tablets
* Drug: Misoprostol Tabets
* Drug: Placebo tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: first trimester of pregnancy pregnancy duration less than 12 weeks based on LMP. non-viable fetus (blighted ovum) Exclusion Criteria: No heart disease, No asthma No History of thromboembolism No History of cancer No renal failure No liver diseases History of allergy to misoprostol or letrozole drugs.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single dose letrozole tablets<br>starting from the first of January, patients will receive a single dose of letrozole (20 mg) two days, before starting misoprostol administration. Placebo tables with a similar appearance to letrozole will be administered the day before misoprostol administration and on the day of misoprostol administration. | Drug: Letrozole tablets<br>* Letrozole is a third-generation non-steroidal aromatase inhibitor<br>Drug: Misoprostol Tabets<br>* a synthetic prostaglandin medication<br>* Other names: prostaglandin E1;Drug: Placebo tablets<br>* Placebo tables with a similar appearance to letrozole<br>|
| Active Comparator: multiple dose letrozole tablets<br>starting from the first of January, patients will receive 10 mg letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration. | Drug: Letrozole tablets<br>* Letrozole is a third-generation non-steroidal aromatase inhibitor<br>Drug: Misoprostol Tabets<br>* a synthetic prostaglandin medication<br>* Other names: prostaglandin E1;|
| Active Comparator: misoprostol tablets<br>starting from the first of January, patients will receive placebo tablets with a similar appearance to letrozole daily for two days before the day of misoprostol administration and on the day of misoprostol administration. | Drug: Misoprostol Tabets<br>* a synthetic prostaglandin medication<br>* Other names: prostaglandin E1;Drug: Placebo tablets<br>* Placebo tables with a similar appearance to letrozole<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete abortion | no emergency or elective curettage was necessary until next menstruation | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Induction-to-abortion interval | the interval between administration of misoprostol) | 2 days | 
| Adverse effects of Misoprostol | diarrhea, abdominal cramps, fever and sweating. | 2 days | 
| Adverse effects of Letrozole | hot flushes, drowsiness and nausea. | 2 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Letrozole, misoprostol, induction of abortion