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this study will compare the efficacy of using letrozole pre treatment before misoprostol versus using misoprostol only in the induction of first trimester missed abortion.
Intervention type: drug
Intervention name: letrozole then misoprostol
Description :letrozole 2.5mg twice per day for 2days then misoprostol 800mcg for all patients to induce abortion
Arm group label:study group
Intervention type :drug
Intervention name:placebo then misoprostol
Description : placebo for 2days then 800mcg misoprostol to all patients to induce abortion
Arm group label: control group
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| letrozole then misoprostol | Experimental | description:letrozole 2.5 mg each 12hours for 2 days at home followed by misoprostol 800mcg vaginally at hospital repeated after 4 hours if needed |
|
| placebo then misoprostol | Placebo Comparator | Description:placebo each 12 hours for 2days at home followed by 800mcg misoprostol vaginally at hospital and repeat dose after 4 hours if needed |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| letrozole | Drug | Letrozole 2.5 mg each 12 hours for 2 days followed by vaginal misoprostol 800 mcg for induction of abortion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete abortion | incidence of complete abortion without the need of surgical evacuation among 110patients in which 55 of patients took letrozole before misoprostol and the other 55 patients took placebo before misoprostol | 6 hours |
| Measure | Description | Time Frame |
|---|---|---|
| surgical evacuation | surgical evacuation for the remnants of conception among 110 patients in which 55 took letrozole before misoprostol and other 55 patients who took placebo before misoprostol | 6 hours |
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Inclusion Criteria:
Exclusion Criteria:
Mullerian Uterine anomalies as septate, bicornuate uterus.
Fibroid uterus.
Coagulopathy.
Medical disorder that contraindicate induction of abortion.
Allergy to misoprostol or letrozole.
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Ages of eligibility :18years and older
sex eligibility :female
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| shereen khedr | Contact | 01011304478 | a.m.agdy@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| shereen khedr | AinShams University | Principal Investigator |
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| ID | Term |
|---|---|
| D000030 | Abortion, Missed |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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participant- care provider -investigator- outcomes assessor
| placebo | Drug | placebo given twice daily for 2 days followed by 800mcg misoprostol vaginally to induce abortion |
|
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |