Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage

NCT ID: NCT06898034

Last Updated: 2025-03-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1725 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-10

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pregnancy Related Post Partum Hemorrhage

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Ultrasound

Postpartum ultrasound exam

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

17 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Endeavor Health

OTHER

Sponsor Role lead

Responsible Party

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Emmet Hirsch

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Endeavor Health

Evanston, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kate Honeyfield

Role: CONTACT

847-570-2243

Facility Contacts

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Emmet Hirsch, MD

Role: primary

Other Identifiers

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STUDY00000080

Identifier Type: -

Identifier Source: org_study_id

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