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This study compares the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of first trimester pregnancy.
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
Hypothesis:
In women with missed miscarriage in the first trimester undergoing induction of abortion pre-treatment with letrozole before misoprostol may lead to abortion rate similar to misoprostol alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Study group | Experimental | 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. |
|
| Control group | Placebo Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole 2.5mg | Drug | total dose 7.5 mg per day for 3 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complete miscarriage | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Need for surgical evacuation of the products of conception | 6 hours | |
| Incidence of Septic Abortion | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dina Mansour | Contact | +20100657 | Dinayahiamansour@hotmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University, Maternity Hospital | Recruiting | Cairo | Egypt |
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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D000030 | Abortion, Missed |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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Randomized
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| Placebo |
| Drug |
Folic acid for 3 days |
|
| Misoprostol | Drug | Misoprosrol 800mcg will be given to all patients for induction of abortion |
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |