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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| letrozole | Active Comparator | 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. |
|
| placebo | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug |
|
| |
| Misoprostol |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Need for surgical evacuation of the products of conception | Need for surgical evacuation of the products of conception
| 1 week |
| Maternal morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University Maternity Hospital | Cairo | Egypt |
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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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| Drug |
|
|
| Placebo | Other |
|
Maternal morbidity
|
| 1 week |
| Hemoglobin and hematocrit deficit | 1 week |
| 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 |