Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

Preeclampsia Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00719537
• Other study ID #: 2008-054
• Status: Terminated
• Phase: N/A
• First received: July 17, 2008
• Last updated: January 16, 2013
• Start date: July 2008
• Est. completion date: March 2011

Study information

• Verified date: January 2013
• Source: William Beaumont Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 3
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pre-Eclampsia
• Preeclampsia

Intervention

Drug:
• Aspirin and progesterone
aspirin 81 mg once a day oral progesterone 200mg twice daily
• Aspirin and placebo
Aspirin 81mg once daily and placebo

Locations

Country	Name	City	State
United States	William Beaumont Hospital	Royal Oak	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
John Uckele

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	reduction in the incidence of preeclampsia		second and third trimester of pregnancy	No
Secondary	Delay in onset of preeclampsia		second and third trimester of pregnancy	No