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Comparison between gemeprost and dinoprostone to evacuate first trimester miscarriages.
Women who are diagnosed with first trimester missed miscarriages are invited to participate in the study. They will be randomised to either gemeprost or dinoprostone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gemeprost | Active Comparator | Gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours. |
|
| Dinoprostone | Active Comparator | Dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gemeprost 1 Mg Vaginal Pessary | Drug | Intravaginal gemeprost 1 mg inserted 3 hourly for maximum of 5 doses in 24 hours |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of women who achieved complete evacuation | Complete expulsion of product of conception | from recruitment until up to one week after commencement of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of women who experienced side effects | side effects towards each drug such as fever, gastrointestinal upset | from recruitment until up to one week after commencement of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Rahana Abd Rahman | National University of Malaysia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UKM Medical Center | Kuala Lumpur | W.Persekutuan | 56000 | Malaysia | ||
| UKM Medical Centre |
Yes
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| ID | Term |
|---|---|
| D000030 | Abortion, Missed |
| D000027 | Abortion, Incomplete |
| D000022 | Abortion, Spontaneous |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| C021182 | gemeprost |
| D013488 | Suppositories |
| D015232 | Dinoprostone |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
| D011458 | Prostaglandins E |
| D011453 | Prostaglandins |
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Comparison between intravaginal gemeprost and dinoprostone.
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| Dinoprostone 3 mg | Drug | Intravaginal dinoprostone 3 mg inserted 4 hourly for maximum of 3 doses in 24 hours |
|
| Kuala Lumpur |
| W.Persekutuan |
| 56000 |
| Malaysia |
| D015777 |
| Eicosanoids |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D008055 | Lipids |
| D012898 | Autacoids |
| D018836 | Inflammation Mediators |
| D001685 | Biological Factors |