Clinical trial NCT00719537: Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Preeclampsia
Keywords: preeclampsia
progesterone
aspirin
prevent
soluble fms-like tyrosine kinase (sFlt-1)
Placental Growth Factor (PlGF)
risk
Lead sponsor: William Beaumont Hospitals
Sponsor class: OTHER
First posted: 2008-07-21
Enrollment: 3
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Incidence of Preeclampsia
timeFrame: second and third trimester of pregnancy
Secondary outcomes:
Other outcomes:
Locations:
city: Royal Oak
country: United States
facility: William Beaumont Hospital
state: Michigan
Study officials:
affiliation: William Beaumont Hospitals
name: John E Uckele, MD
role: PRINCIPAL_INVESTIGATOR
References: