Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage

NCT06898034 | Recruiting

• 1 other identifier: STUDY00000080
• Study Type: observational
• Target: 1,725
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy Related; Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (5)

• Ultrasound exam: uterine measurements

  * Uterine length (cm) * Uterine width (cm) * Uterine height (cm) These will be correlated with subsequent clinical outcomes, including bleeding events.

  From enrollment to 1.5-2 hours post partum

• Ultrasound exam: endometrial stripe

  Width (cm) of the endometrial stripe (measuring displacement of the uterine walls by intrauterine contents (blood, clots, retained placental fragments or other) to include Doppler study) at 3 levels: * Fundal * Lower uterine segment * Cervix These will be correlated with subsequent clinical outcomes, including bleeding events.

  From enrollment to 1.5-2 hours post partum

• Ultrasound exam:fibroids

  Presence of uterine fibroids (number and size in cm of each) These will be correlated with subsequent clinical outcomes, including bleeding events.

  From enrollment to 1.5-2 hours post partum

• Ultrasound exam: Vagina

  Caliber of the vagina (cm) (to assess distension by clot) These will be correlated with subsequent clinical outcomes, including bleeding events.

  From enrollment to 1.5-2 hours post partum

• Ultrasound exam: Bladder

  * Bladder length (cm) * Bladder height (cm) * Bladder width (cm) All other aspects of clinical management will be left to the discretion of the clinical team. These will be correlated with subsequent clinical outcomes, including bleeding events.

  From enrollment to 1.5-2 hours post partum

Secondary Outcomes (1)

• Chart review

  From enrollment to 6 weeks post partum

Interventions

Ultrasound OTHER

Postpartum ultrasound exam

Eligibility Criteria

• Age: 17 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

Endeavor Health

Evanston, Illinois, 60201, United States

RECRUITING

MeSH Terms

Conditions

Postpartum Hemorrhage

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Central Study Contacts

Kate Honeyfield

CONTACT

847-570-2243; KHoneyfield@northshore.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 27, 2025
• Study Start: March 10, 2025
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)