Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

Not Applicable

Terminated

• Conditions: Preeclampsia
• Interventions: Drug: Aspirin; Drug: Placebo Oral Tablet; Drug: Progesterone

• Registration Number: NCT00719537
• Lead Sponsor: John Uckele

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-07-17
• Study First Submitted QC: 2008-07-18
• Study First Posted: 2008-07-21
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2016-11-02
• Status Verified: 2017-03
• Results First Submitted QC: 2017-03-03
• Last Update Submitted: 2017-03-03
• Results First Posted: 2017-04-17
• Last Update Posted: 2017-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 3

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aspirin plus Placebo Oral Tablet	Aspirin	Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
Aspirin plus Placebo Oral Tablet	Placebo Oral Tablet	Drug: Aspirin 81 mg, given orally once per day Drug: Placebo tablet given orally, once a day
Aspirin plus Progesterone	Aspirin	Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day
Aspirin plus Progesterone	Progesterone	Drug: Aspirin 81mg, given orally once per day Drug: Progesterone 200mg given orally, once a day

Primary Outcome Measures

Name	Time	Method
Incidence of Preeclampsia	second and third trimester of pregnancy	Number of Participants with preeclampsia in second and third trimester of pregnancy.

Trial Locations

Locations (1)

William Beaumont Hospital; 🇺🇸 Royal Oak, Michigan, United States