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| Name | Class |
|---|---|
| Benha University | OTHER |
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Aim of study Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
Aim of the Work
Compare the success rate of misoprostol with versus without letrozole as a pretreatment for medical termination of pregnancy during the first trimester.
Hypothesis:
Letrozole value as a pre-treatment medication for misoprostol in induction of abortion during the first trimester.
Research question:
Will letrozole- misoprostol protocol give better results than misoprostol- alone protocol in induction of abortion during the first trimester?
Primary outcome:
Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol.
Secondary outcome:
• Curettage (surgical evacuation of the products of conception)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Letrozole misoprostol | Group (A): A participant will receive three tablets of letrozole (Letrozole®, Technopharma) as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start |
| |
| Misoprostol,placebo | Group (B): A participant will receive three tablets of placebo as a single dose on day One, then she took the second dose herself on day Two and will be told to bring back the empty pack. The third dose will be given on admission to hospital on day Three followed by 4 tablets of vaginal misoprostol (200 μg) (Cytotec®, Pfizer) soaked with saline every three hours for maximum two doses.then give antibiotics when abortion start |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole misoprostol | Device | Letrozole give pretreatment of abortion by misoprostol |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete abortion | Complete abortion (complete expulsion of products of conception with no need for curettage) within one week from the first dose of misoprostol. | 1week |
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Inclusion Criteria:
Exclusion criteria:
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Study Settings:
This clinical trial will be conducted in department of obstetrics and gynecology at Zagazig General Hospital during the period between January 2019 and June 2019.
Study Population:
The patients will be recruited from women attending outpatient clinic of obstetrics or the emergency room of Zagazig General Hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Zagazig General hospital, Ministry hospital | Zagazig general hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dalia Mohammed Al Sayed Zaki | Zagazig | Sharqia Province | 1436 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21252745 | Result | Lee VCY, Ng EHY, Yeung WSB, Ho PC. Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial. Obstet Gynecol. 2011 Feb;117(2 Pt 1):317-323. doi: 10.1097/AOG.0b013e3182073fbf. |
| Label | URL |
|---|---|
| Misoprostol with or without letrozole pretreatment for termination of pregnancy: a randomized controlled trial | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| Individual Participant Data Set | View IPD |
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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 |
|---|---|
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D011459 | Prostaglandins E, Synthetic |
| D011465 | Prostaglandins, Synthetic |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
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| Misoprostol, placebo | Drug | Give placebo pretreatment of abortion by misoprostol |
|
Albrecht ED, Aberdeen GW, Pepe GJ, (2000). The role of estrogen in the maintenance of primate pregnancy. Am J Obstet Gynecol. 182:432-8. Albrecht ED, Robb VA, Pepe GJ, (2004). Regulation of placental vascular endothelial growth permeability factor expression and angiogenesis by estrogen during early baboon pregnancy. J Clin Endocrinol Metab. 89: |
| D005231 |
| Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |