Preeclampsia
Conditions
Keywords
preeclampsia, progesterone, aspirin, prevent, soluble fms-like tyrosine kinase (sFlt-1), Placental Growth Factor (PlGF), risk
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.
Interventions
DRUGAspirin
Aspirin 81 mg once a day
DRUGPlacebo Oral Tablet
Placebo 1 tab Daily
DRUGProgesterone
Oral Progesterone 200 mg Twice Daily
Sponsors
John Uckele
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Preeclampsia | second and third trimester of pregnancy | Number of Participants with preeclampsia in second and third trimester of pregnancy. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Aspirin and Placebo Aspirin and placebo: Aspirin 81mg once daily and placebo once daily | 2 |
| Aspirin and Progesterone aspirin 81 mg once a day oral progesterone 200mg twice daily | 1 |
| Total | 3 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Aspirin and Placebo | Aspirin and Progesterone | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 1 Participants | 3 Participants |
| Region of Enrollment United States | 2 participants | 1 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 2 | 0 / 1 |
| other Total, other adverse events | 0 / 2 | 0 / 1 |
| serious Total, serious adverse events | 0 / 2 | 0 / 1 |
Outcome results
Primary
Incidence of Preeclampsia
Number of Participants with preeclampsia in second and third trimester of pregnancy.
Time frame: second and third trimester of pregnancy
Population: 1 Participant withdrawn in aspirin and placebo group, one participant lost to followup in aspirin and progesterone group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Aspirin and Placebo | Incidence of Preeclampsia | 0 Participants |