Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00719537|
Recruitment Status : Terminated (inability to find qualifying participants)
First Posted : July 21, 2008
Results First Posted : April 17, 2017
Last Update Posted : April 17, 2017
|Condition or disease||Intervention/treatment||Phase|
|Preeclampsia||Drug: Aspirin Drug: Placebo Oral Tablet Drug: Progesterone||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||3 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia in Patients With a Prior History of Preeclampsia: A Prospective, Randomized Clinical Trial|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||March 2011|
|Actual Study Completion Date :||March 2011|
Placebo Comparator: Aspirin plus Placebo Oral Tablet
Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
Aspirin 81 mg once a day
Drug: Placebo Oral Tablet
Placebo 1 tab Daily
Active Comparator: Aspirin plus Progesterone
Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
Aspirin 81 mg once a day
Oral Progesterone 200 mg Twice Daily
- Incidence of Preeclampsia [ Time Frame: second and third trimester of pregnancy ]Number of Participants with preeclampsia in second and third trimester of pregnancy.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719537
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||John E Uckele, MD||William Beaumont Hospitals|