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This study compares the success rate of Adjuvant isonicotinic acid hydrazide and misoprostol versus misoprostol alone for medical termination of first-trimester pregnancy among women with one or more previous cesarean deliveries.
In the past, the role of laminaria and prostaglandins in cervical dilatation and reducing intraoperative complications of cervical dilatation have been proven . Misoprostol is a synthetic analogue of prostaglandin E1 used to treat and prevent gastric ulcers, which is now widely used in obstetrics and gynecology. Its applications in obstetrics and gynecology include medical abortion in the first and second trimesters of pregnancy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| INH | Experimental | 3 tablets of isonicotinic acid hydrazide 300 mg will be given as single daily dose, 900 mg per day for two days at home and the third dose will be given on admission to hospital on day 3 and will be followed by vaginal misoprostol 800 mcg every three hours up to maximum two doses. |
|
| Placebo Comparator | Placebo Comparator | three tablets of placebo will be given as a single daily dose, for two days at home and will be admitted on day 3 and continue treatment with misoprostol 800 mcg every three hours up to maximum two doses |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Isonicotinic Acid | Drug | Drug: Isonicotinic Acid then misoprostol Drug: Isonicotinic Acid 300mg total dose 900 mg per day for 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| induction to abortion time | induction to abortion time | 9 hours |
| number of patient with complete abortion | number of patient with complete abortion | 9 hours |
| Measure | Description | Time Frame |
|---|---|---|
| number of patient need for surgical evacuation of the products of conception | number of patient need for surgical evacuation of the products of conception | 12 hours |
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Inclusion Criteria:
Exclusion Criteria:
women with one or more previous cesarean deliveries with missed miscarriage
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hany f Sallam, md | Contact | +20102435461 | 002 | hany.farouk@aswu.edu.eg |
| nahla w Shady, md | Contact | +201022336052 | 002 | hanygyne@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| nahla w Shady | Aswan universirty | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aswan University Hospital | Aswān | 81528 | Egypt |
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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 |
|---|---|
| D007539 | Isonicotinic Acids |
| D016595 | Misoprostol |
| ID | Term |
|---|---|
| D000147 | Acids, Heterocyclic |
| D006571 | Heterocyclic Compounds |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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double blind randomized controlled study
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double blind randomized controlled study
| Placebo | Drug | Drug: placebo then misoprostol Drug: Placebo placebo for 3 days |
|
| Misoprostol | Drug | Drug: Misoprostol Misoprosrol 800mcg will be given to all patients for induction of abortion |
|
| 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 |