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| Name | Class |
|---|---|
| Vastra Gotaland Region | OTHER_GOV |
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The aim of this study is to examine whether treatment with 75 mg aspirin daily compared with placebo could reduce the risk for a new miscarriage. The treatment starts when the pregnancy is detected on transvaginal ultrasound (around gestational week 6+) and continues to week 35/36. The study is a single center, randomized, placebo-controlled, double blind and stratified for age. 400 participants with the diagnosis idiopathic recurrent abortion are enrolled, 200 in each arm aspirin / placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose aspirin | Experimental | 75 mg aspirin orally daily from gestational week 7-35 |
|
| Placebo | Placebo Comparator | Placebo pill orally daily from gestational week 7-35 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Daily medication |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Live birth | delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Spontaneous abortion | up to 22 weeks | |
| Vaginal bleeding | up to 42 weeks | |
| Premature delivery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Annika Strandell, Ass.prof. | Göteborg University | Principal Investigator |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Mar 2, 2021 | |
| Reset | Mar 25, 2021 | |
| Release | Apr 3, 2023 | |
| Reset | Apr 25, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Mar 2, 2021 | Mar 25, 2021 | |||
| Apr 3, 2023 |
| ID | Term |
|---|---|
| D000026 | Abortion, Habitual |
| ID | Term |
|---|---|
| D000022 | Abortion, Spontaneous |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo |
| Drug |
Daily intake |
|
| At delivery |
| intrauterine growth retardation, measured by ultrasound as percentage deviation | up to 42 weeks |
| Preeclampsia | up to 42 weeks |
| Pregnancy induced hypertension | up to 42 weeks |
| Placenta praevia | up to 42 weeks |
| Perinatal mortality | Third trimester and 28 days after delivery |
| Perinatal morbidity | 28 days after delivery |
| Apr 25, 2023 |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |