Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|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|
- Incidence of Preeclampsia [ Time Frame: second and third trimester of pregnancy ]Number of Participants with preeclampsia in second and third trimester of pregnancy.
|Study Start Date:||July 2008|
|Study Completion Date:||March 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
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 dayDrug: 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 dayDrug: Progesterone
Oral Progesterone 200 mg Twice Daily
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00719537
|United States, Michigan|
|William Beaumont Hospital|
|Royal Oak, Michigan, United States, 48073|
|Principal Investigator:||John E Uckele, MD||William Beaumont Hospitals|