Oral Progesterone and Low Dose Aspirin in the Prevention of Preeclampsia

John Uckele

Status: Terminated

Conditions: Preeclampsia

Treatments: Drug: Progesterone; Drug: Placebo Oral Tablet; Drug: Aspirin

Study type: Interventional

Funder types: Other

Identifiers

NCT00719537

2008-054

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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3 participants in 2 patient groups, including a placebo group

Aspirin plus Placebo Oral Tablet

Placebo Comparator group

Description:

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

Treatment:

Drug: Aspirin

Drug: Placebo Oral Tablet

Aspirin plus Progesterone

Active Comparator group

Description:

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

Treatment:

Drug: Aspirin

Drug: Progesterone