Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Preeclampsia

Intervention / Treatment
-----------------
* Drug: Aspirin
* Drug: Placebo Oral Tablet
* Drug: Progesterone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pregnant patients with a previous history of preeclampsia in the immediate preceding pregnancy. 18 to 45 years of age will be included. Exclusion Criteria: Patients with chronic hypertension children (age < 17 years) Patients that are currently taking anti-psychotics or Selective Serotonin Re-uptake Inhibitors patients on medications which may be detrimental to the study interpretation will also be excluded at the principal investigator's discretion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Aspirin plus Placebo Oral Tablet<br>Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day | Drug: Aspirin<br>* Aspirin 81 mg once a day<br>Drug: Placebo Oral Tablet<br>* Placebo 1 tab Daily<br>|
| Active Comparator: Aspirin plus Progesterone<br>Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day | Drug: Aspirin<br>* Aspirin 81 mg once a day<br>Drug: Progesterone<br>* Oral Progesterone 200 mg Twice Daily<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preeclampsia, progesterone, aspirin, prevent, soluble fms-like tyrosine kinase (sFlt-1), Placental Growth Factor (PlGF), risk