Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

March 3, 2017 updated by: John Uckele

Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia in Patients With a Prior History of Preeclampsia: A Prospective, Randomized Clinical Trial

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

3

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Michigan
      • Royal Oak, Michigan, United States, 48073
        • William Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Aspirin plus Placebo Oral Tablet
Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
Drug: Aspirin
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
Drug: Aspirin
Aspirin 81 mg once a day
Drug: Progesterone
Oral Progesterone 200 mg Twice Daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Preeclampsia
Time Frame: second and third trimester of pregnancy
Number of Participants with preeclampsia in second and third trimester of pregnancy.
second and third trimester of pregnancy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

John Uckele

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (ACTUAL)

March 1, 2011

Study Completion (ACTUAL)

March 1, 2011

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (ESTIMATE)

July 21, 2008

Study Record Updates

Last Update Posted (ACTUAL)

April 17, 2017

Last Update Submitted That Met QC Criteria

March 3, 2017

Last Verified

March 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No study data is available, will not be shared.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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