Postpartum Low-Dose Aspirin and Preeclampsia
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 1/23/2019 |
| Start Date: | January 7, 2019 |
| End Date: | April 2020 |
| Contact: | Kirsten Cleary, MD |
| Email: | klc2108@cumc.columbia.edu |
| Phone: | 212-305-6293 |
Low-Dose Aspirin in the Postpartum Period and Endothelial Function in Patients With Preeclampsia
The purpose of this research study is to find out whether women with preeclampsia taking
low-dose aspirin (LDA) for 6 weeks post-delivery will experience an improvement in
endothelial function (measured as flow-mediated dilation - FMD) and severity of disease, as
the effects of preeclampsia can persist postpartum. Women diagnosed with preeclampsia prior
to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or
placebo to take daily for up to 6 weeks post-delivery.
low-dose aspirin (LDA) for 6 weeks post-delivery will experience an improvement in
endothelial function (measured as flow-mediated dilation - FMD) and severity of disease, as
the effects of preeclampsia can persist postpartum. Women diagnosed with preeclampsia prior
to delivery will be enrolled and randomized to receive either low-dose aspirin (81mg) or
placebo to take daily for up to 6 weeks post-delivery.
Preeclampsia is a serious disease of pregnancy that manifests with increased blood pressure
and can affect all the organs in a woman's body. It usually develops after 20 weeks of
pregnancy. There is an abnormal amount of protein in the urine and with worsening disease
known as "severe features," patients can have pain in the upper abdomen, changes in vision,
fluid in the lungs, an intense headache, low number of platelets in the blood, and abnormal
liver or kidney function. Very high blood pressure is also considered a severe feature. The
exact cause of preeclampsia is unknown but women with the condition are at increased risk for
complications during pregnancy, including seizures - eclampsia. Babies are at risk of being
born premature because the only cure for preeclampsia is delivery. Women who have had
preeclampsia are also at increased risk of cardiovascular and kidney disease later in life,
including heart attack, stroke and high blood pressure.Studies show that women at high risk
for preeclampsia, ie. have had preeclampsia in a prior pregnancy, are carrying more than one
fetus, have a history of high blood pressure, kidney disease or both, have certain medical
problems such as diabetes, thrombophilia or lupus, have a modestly decreased risk of disease
with daily intake of low-dose aspirin starting after 12 weeks of pregnancy.
Due to the limited data available on the topic of LDA in preeclamptic patients in the
postpartum period, particularly as applicable to the American population, the investigator
intends to start with a small pilot study involving the collection of information on 10 women
not exposed to study intervention. This will allow for confirmation of the sample size based
on the baseline FMD measurements 2 days after delivery.
and can affect all the organs in a woman's body. It usually develops after 20 weeks of
pregnancy. There is an abnormal amount of protein in the urine and with worsening disease
known as "severe features," patients can have pain in the upper abdomen, changes in vision,
fluid in the lungs, an intense headache, low number of platelets in the blood, and abnormal
liver or kidney function. Very high blood pressure is also considered a severe feature. The
exact cause of preeclampsia is unknown but women with the condition are at increased risk for
complications during pregnancy, including seizures - eclampsia. Babies are at risk of being
born premature because the only cure for preeclampsia is delivery. Women who have had
preeclampsia are also at increased risk of cardiovascular and kidney disease later in life,
including heart attack, stroke and high blood pressure.Studies show that women at high risk
for preeclampsia, ie. have had preeclampsia in a prior pregnancy, are carrying more than one
fetus, have a history of high blood pressure, kidney disease or both, have certain medical
problems such as diabetes, thrombophilia or lupus, have a modestly decreased risk of disease
with daily intake of low-dose aspirin starting after 12 weeks of pregnancy.
Due to the limited data available on the topic of LDA in preeclamptic patients in the
postpartum period, particularly as applicable to the American population, the investigator
intends to start with a small pilot study involving the collection of information on 10 women
not exposed to study intervention. This will allow for confirmation of the sample size based
on the baseline FMD measurements 2 days after delivery.
Inclusion Criteria:
- Singleton gestation
- Maternal age >= 18 years
- 20 0/7 to 40 6/7 weeks gestation
- Preeclampsia diagnosed prior to delivery
Exclusion Criteria:
- Multiple gestation
- Aspirin use postpartum for other medical indication
- Hypersensitivity or allergy to Aspirin or other salicylates
- Hypersensitivity or allergy to nonsteroidal anti-inflammatory drugs (NSAIDs)
- Nasal polyps
- Gastric or Duodenal ulcers, history of GI bleeding
- Renal or severe hepatic dysfunction
- Bleeding diathesis
- Breastfeeding a newborn with low platelets (NAIT)
- Patients enrolled in the Pravastatin and Chronic Hypertension and Pregnancy (CHAP)
studies
We found this trial at
1
site
New York, New York 10032
Principal Investigator: Kirsten Cleary, MD
Phone: 646-678-0289
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