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inability to find qualifying participants
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This study investigates whether low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy.
Recent advances have shown that certain proteins may be present in a pregnant woman's blood very early in pregnancy which can predict who is at the highest risk for developing preeclampsia. These proteins can be measured and may be used to predict a woman's risk of developing preeclampsia.
Special placental cells called endovascular cytotrophoblasts are needed in the early formation of the placenta. These placental cells invade the maternal blood vessels in the formation of the maternal-placental blood interface. Human Leukocytes Antigen-G (HLA-G) is a protein produced by the placental cells and prevents these special cells from being rejected by the mother's immune system. Recent studies have indicated that the level of HLA-G is decreased in placentas from mothers with preeclampsia. Progesterone, a naturally occurring hormone produced in pregnancy, has been shown to increase the production of HLA-G in the placental cytotrophoblast cells.
In regards to the treatment of preeclampsia, studies have shown that low dose aspirin if given to mothers who have had severe early preeclampsia, lowers the risk for having preeclampsia again. This study aims to show that low dose aspirin combined with progesterone will decrease the risk of preeclampsia in pregnant women with a history of preeclampsia in a previous pregnancy. Data generated will determine levels and ratios of blood proteins that are predictive of preeclampsia at specific gestational ages.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aspirin plus Placebo Oral Tablet | Placebo Comparator | Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day |
|
| Aspirin plus Progesterone | Active Comparator | Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aspirin | Drug | Aspirin 81 mg once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Preeclampsia | Number of Participants with preeclampsia in second and third trimester of pregnancy. | second and third trimester of pregnancy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John E Uckele, MD | Corewell Health East | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Beaumont Hospital | Royal Oak | Michigan | 48073 | United States |
No study data is available, will not be shared.
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| ID | Title | Description |
|---|---|---|
| FG000 | Aspirin and Placebo | Aspirin and placebo: Aspirin 81mg once daily and placebo once daily |
| FG001 | Aspirin and Progesterone | aspirin 81 mg once a day oral progesterone 200mg twice daily |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Aspirin and Placebo | Aspirin and placebo: Aspirin 81mg once daily and placebo once daily |
| BG001 | Aspirin and Progesterone | aspirin 81 mg once a day oral progesterone 200mg twice daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 18-50 years, female |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence of Preeclampsia | Number of Participants with preeclampsia in second and third trimester of pregnancy. | 1 Participant withdrawn in aspirin and placebo group, one participant lost to followup in aspirin and progesterone group. | Posted | Count of Participants | Participants | second and third trimester of pregnancy |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Aspirin and Placebo | Aspirin and placebo: Aspirin 81mg once daily and placebo |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Uckele | William Beaumont Hospital | 2485510610 | john.uckele@beaumont.edu |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| D011374 | Progesterone |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo Oral Tablet | Drug | Placebo 1 tab Daily |
|
| Progesterone | Drug | Oral Progesterone 200 mg Twice Daily |
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| 0 |
| 2 |
| 0 |
| 2 |
| 0 |
| 2 |
| EG001 | Aspirin and Progesterone | Aspirin and progesterone: aspirin 81 mg once a day oral progesterone 200mg twice daily | 0 | 1 | 0 | 1 | 0 | 1 |
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| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D003339 | Corpus Luteum Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |