Clinical trial NCT06898034: Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
Official title: Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pregnancy Related
Post Partum Hemorrhage
Lead sponsor: Endeavor Health
Sponsor class: OTHER
First posted: 2025-03-27
Enrollment: 1725
Sex: FEMALE
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients admitted to Labor and Delivery for term delivery at Evanston, Highland Park or Swedish Hospitals (≥ 37 weeks' gestation at any maternal age, not decisionally impaired) will be eligible to participate.

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Ultrasound exam: uterine measurements
timeFrame: From enrollment to 1.5-2 hours post partum
measure: Ultrasound exam: endometrial stripe
timeFrame: From enrollment to 1.5-2 hours post partum
measure: Ultrasound exam:fibroids
timeFrame: From enrollment to 1.5-2 hours post partum
measure: Ultrasound exam: Vagina
timeFrame: From enrollment to 1.5-2 hours post partum
measure: Ultrasound exam: Bladder
timeFrame: From enrollment to 1.5-2 hours post partum
Secondary outcomes:
measure: Chart review
timeFrame: From enrollment to 6 weeks post partum
Other outcomes:
Locations:
city: Evanston
country: United States
facility: Endeavor Health
state: Illinois
Study officials:
References: