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To compare the success rate of letrozole and misoprostol versus misoprostol alone for medical termination of pregnancy in second trimester abortion.
This prospective double-blind, randomized, clinical trial, will be conducted at Ain Shams University Maternity Hospital.
Patients fulfilling inclusion and exclusion criteria will be divided into two groups.
Group (A):
181 women will receive three tablets of letrozole (On December 28, 2005, the U.S. Food and Drug Administration approved letrozole tablets (Femara®, made by Novartis Pharmaceuticals Corp.) 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 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Group (B):
181 women will receive three tablets of placebo (manufactured by Egyptian Group Company for drug industries) 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 400 mcg vaginal misoprostol soaked with saline every three hours up to maximum five doses on Day 3.
Data recording:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| letrozole + misoprostol | Experimental | Women will receive three tablets of letrozole vaginal as a single dose, each tablet 2.5 mg (total dose 7.5 mg per day) for three days and will be followed by 200 mcg vaginal misoprostol or 100mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses. |
|
| placebo + misoprostol | Placebo Comparator | Women will receive three tablets of placebo vaginal as a single dose, for three days and will be followed by 200 mcg vaginal misoprostol or 100 mcg vaginal misoprostol (according gestational age) soaked with saline every six hours up to maximum four doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Letrozole | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of induction of abortion | 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of need for surgical evacuation of placenta. | 24 hours | |
| Hemoglobin change | 24 hours | |
| Maternal morbidity |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mostafa Gomaa, MD | Ain Shams University | Principal Investigator |
| Ihab Serag-ElDin, MD | Ain Shams University | Study Director |
| Gasser El-Bishry, FRCOG | Ain Shams University | Study Director |
| Ahmed Swidan, M.B.B.ch | Ain Shams University | Principal Investigator |
| Mohamed S. Sweed, MD | Ain Shams University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Cairo | Egypt |
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| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| 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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| Drug |
|
| Misoprostol | Drug |
|
| 24 hours |
| Success of induction of abortion | number of participants with Success of induction of abortion | 24 hours |
| Hematocrit change | 24 hours |
| 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 |