Formal Study NamePreserve-1 Early-Onset Preeclampsia
Primary Principal InvestigatorErika Werner
Study InformationThe purpose of the PRESERVE-1 clinical trial is to evaluate the safety and effectiveness of antithrombin (recombinant) for the treatment of early-onset preeclampsia. Antithrombin (recombinant) is used to replace a naturally occurring substance in the body callied antithrombin, which your body uses to keep blood clots from forming. Women who develop early-onset preeclampsia generally have lower than normal antithrombin levels. The study will assess if antithrombin (recombinant) can increase the time that your baby stays in the womb, decrease problems that you may experience and/or improve the health and wellbeing of your baby.
What is preeclampsia?
Preeclampsia is a serious medical condition that occurs in pregnant women. Preeclampsia is a disease of the placenta, which is an organ that provides food, oxygen and nutrients to the baby. It occurs in six to eight percent of all pregnancies in the United States, usually during the second or third trimester. Preeclampsia can affect the health of the mother and her child. High blood pressure is the most common symptom.
Symptoms of preeclampsia
High blood pressure
Stomach pain and nausea
Swelling of the hands, feet and/or face
Altered mental state
How is preeclampsia currently treated?
When preeclampsia occurs between the 23rd and 30th week of pregnancy, the condition is called early-onset preeclampsia and the baby is at risk for being born before the baby is ready.
The only known treatment for preeclampsia is to deliver the baby. Currently, patients are "expectantly managed" when the mother's health permits. "Expectant management" involves careful monitoring of the mother and her baby with the goal of delaying the delivery of the baby. The mother may also receive medications to help reduce her blood pressure and to protect her from other serious problems.
Because babies born too early may have health issues, it is better to delay the delivery of the baby as long as possible. This allows the baby to grow and develop. Every day of the pregnancy may make a difference to a baby's health.
What to expect
First it will be confirmed if you meet the criteria to participate in the study. If you are enrolled in the study, you will receive expectant management, which you would receive regardless of your participation in this study.
You will be randomly selected to receive antithrombin (recombinant) or an inactive saline solution called placebo. Treatment with antithrombin (recombinant) or placebo will be given via a continuous IV infusion. Neither you, not your doctor or nurses will know whether you are receiving antithrombin (recombinant) or placebo, so that any expectations you or the hospital staff may have do not affect the study. In addition, your medical team will:
- Monitor you and your baby as they normally would, regardless of your participation in the study
- Check your vital signs twice a day
- Obtain lab tests of your blood and urine to monitor your health and effects of the study drug
- Check your medications used/taken during the study
- Check your body weight
- Record information about specific preeclampsia related conditions or any other health issues you or your baby experience
How long you will be in this study depends on when your baby is delivered. you will be given antithrombin (recombinant) or placebo until a decision has been made to deliver your baby or you are 34 weeks pregnant.
Once your baby is born, you will have one visit prior to your discharge from the hospital and on additional follow up and exam, approximately 4 to 6 weeks after your delivery. Your baby will be followed for approximately 4 to 12 weeks after birth depending on when he or she is born.
Women & Infants