Purpose of this Study
People who join this study will take one study pill every day until they are 36 weeks pregnant. They will also have monthly visits with the study team, either in person or virtually, until their baby is born. Researchers will collect health information about both the mother and baby through the time they leave the hospital after delivery. The goal is to learn if the study treatment can help lower the chance of another early birth.
Who Can Participate?
Eligibility
People may be able to join this study if they are pregnant with one baby and are between 10 weeks and 15 weeks, 6 days pregnant. They must have had a previous pregnancy that ended before 35 weeks, meaning the baby was born more than five weeks early. Researchers are studying whether taking aspirin during pregnancy can help lower the chance of another preterm birth.
Age Range
14-110
Sex/Genders
Female (cisgender)
Non-binary or gender fluid
Looking for Healthy Participants
No
What is Involved?
Description
This study is testing whether two different doses of aspirin can help lower the chance of having another preterm birth. Researchers want to learn if taking 162 milligrams of aspirin works better than 81 milligrams of aspirin for preventing early delivery.
Participants will take one aspirin pill each day during pregnancy and have regular checkups with the study team. The goal is to find the best aspirin dose to help reduce the risk of delivering a baby too early, regardless of the reason for the previous preterm birth.
Locations
Other
Visit Timing
Weekdays
Compensation
Yes
Spanish Materials Available
Yes
Study Details
Full Title
Aspirin Dose Escalation for the Prevention of recurrent preterm delivery Trial
Principal Investigator
Brenna
Hughes
Protocol Number
PRO00117034
Phase
III
Enrollment Status
Open to Enrollment