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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single dose letrozole tablets | Active Comparator | 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. |
|
| multiple dose letrozole tablets | Active Comparator | 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. |
|
| misoprostol tablets | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole tablets | Drug | Letrozole is a third-generation non-steroidal aromatase inhibitor |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete abortion | no emergency or elective curettage was necessary until next menstruation | 2 days |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marwa M Abdalla, MD | Kasralainy teaching hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cairo University | Cairo | 12613 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21693030 | Background | Fouda UM, Sayed AM. Extended letrozole regimen versus clomiphene citrate for superovulation in patients with unexplained infertility undergoing intrauterine insemination: a randomized controlled trial. Reprod Biol Endocrinol. 2011 Jun 21;9:84. doi: 10.1186/1477-7827-9-84. | |
| 30647756 | Background | Abbasalizadeh F, Sahhaf F, Sadeghi-Shabestari P, Mirza-Aghazadeh-Attari M, Naghavi-Behzad M. Comparison Between Effect of Letrozole Plus Misoprostol and Misoprostol Alone in Terminating Non-Viable First Trimester Pregnancies: A Single Blind Randomized Trial. J Family Reprod Health. 2018 Mar;12(1):27-33. |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D000527 | Alprostadil |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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A randomized controlled trial
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| Misoprostol Tabets | Drug | a synthetic prostaglandin medication |
|
|
| Placebo tablets | Drug | Placebo tables with a similar appearance to letrozole |
|
| 2 days |
| Adverse effects of Letrozole | hot flushes, drowsiness and nausea. | 2 days |
| 21252745 | Background | 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. |
| 22302719 | Background | Lee VC, Yeung TW, Tang OS, Ng EH, Yeung WS, Ho PC. Effect of letrozole on uterine artery Doppler flow indices prior to first-trimester termination of pregnancy: a randomized controlled trial. Ultrasound Obstet Gynecol. 2012 Oct;40(4):392-7. doi: 10.1002/uog.11115. |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
| D015777 | Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D005229 | Fatty Acids, Monounsaturated |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |