Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage

Endeavor Health

Status: Enrolling

Conditions: Pregnancy Related; Post Partum Hemorrhage

Treatments: Other: Ultrasound

Study type: Observational

Funder types: Other

Identifiers

NCT06898034

STUDY00000080

Details and patient eligibility

About

Up to 5% of patients in the United States have a postpartum hemorrhage. "Postpartum hemorrhage" means excessive bleeding after delivery. The majority of these bleeds occur immediately with delivery.

The current study focuses on hemorrhages that occur in the "medium-term" (1.5-24 hours after delivery). Investigators are examining whether ultrasound exams performed at the beginning of this period 1.5 to 2 hours after birth can identify markers that predict a medium-term bleed. Data collected for this study will include medical and obstetrical history, details about the course and outcomes of patients' labor and delivery, and particulars about postpartum bleeding. This information will be collected through the end of the patients' delivery admission and will allow correlation with the results of the ultrasound exam. If patients are re-admitted to the hospital after the delivery discharge, investigators may also collect relevant information about those admissions up to 6 weeks postpartum.

All patients after term delivery (≥ 37 weeks' gestation) will be eligible to participate. Patients will be approached to provide consent for participation as early as feasible during a prenatal visit (≥ 36 weeks' gestation) or during the delivery admission. No subjects will be consented while in significant pain, >6cm dilated without an epidural, or >8cm dilatated with an epidural.

Enrollment: 1,725 estimated patients

Sex: Female

Ages: 17+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Currently pregnant and planning to deliver at Endeavor Health >37 weeks gestational age
• English speaking
• Labor <6cm dilated at time of consent without epidural
• Labor <8cm dilated at time of consent with epidural

Exclusion criteria

• Preterm delivery
• Non-English speaking
• Any conditions that impairs potential participants decision making