ROTEM® Obstetric Hemorrhage Pilot Study (NCT04409015) | Clinical Trial Compass
CompletedNot Applicable
ROTEM® Obstetric Hemorrhage Pilot Study
United States60 participantsStarted 2020-07-27
Plain-language summary
This is a prospective observational study among women at high-risk of postpartum hemorrhage, in their third trimester who are admitted to Labor \&Delivery in spontaneous labor, for induction of labor, or for scheduled cesarean section.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥ 18 years and able to provide consent
. Gestational age ≥ 34 weeks
. ≥ 1 High-risk of postpartum hemorrhage criteria defined as either of:
. Nulliparous women admitted for induction of labor with unfavorable cervix (Bishop's score \<5)
. Prior uterine surgery (\> 1 prior cesarean or myomectomy)
. Patients undergoing trial of labor after cesarean delivery
. History of postpartum hemorrhage
. ≥4 previous vaginal deliveries
Exclusion criteria
. Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to sample collection is not an exclusion)
. Antepartum hemorrhage present on admission (\>500cc Estimated Blood Loss (EBL))
. Coagulation defects
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.
Timeframe: After delivery through study completion, an average of 2 years
. Enrolled in the "Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean (TXA)" (NCT03364491) study or planned receipt of Tranexamic Acid (TXA) prior to enrollment.