Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

NCT ID: NCT00719537

Last Updated: 2017-04-17

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2011-03-31

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.

Conditions

Preeclampsia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Aspirin plus Placebo Oral Tablet

Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day

Group Type: PLACEBO_COMPARATOR

Aspirin

Intervention Type: DRUG

Aspirin 81 mg once a day

Placebo Oral Tablet

Intervention Type: DRUG

Placebo 1 tab Daily

Aspirin plus Progesterone

Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day

Group Type: ACTIVE_COMPARATOR

Aspirin

Intervention Type: DRUG

Aspirin 81 mg once a day

Progesterone

Intervention Type: DRUG

Oral Progesterone 200 mg Twice Daily

Interventions

Aspirin

Aspirin 81 mg once a day

Intervention Type: DRUG

Placebo Oral Tablet

Placebo 1 tab Daily

Intervention Type: DRUG

Progesterone

Oral Progesterone 200 mg Twice Daily

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

John Uckele

OTHER

Sponsor Role: lead

Responsible Party

John Uckele

Medical Doctor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

John E Uckele, MD

Role: PRINCIPAL_INVESTIGATOR

William Beaumont Hospitals

Locations

William Beaumont Hospital

Royal Oak, Michigan, United States

Countries

United States

Other Identifiers

2008-054

Identifier Type: -

Identifier Source: org_study_id