Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06898034

Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Pregnancy Related Female Urogenital Diseases and Pregnancy Complications Hemorrhage Obstetric Labor Complications Pathologic Processes Pathological Conditions, Signs and Symptoms Post Partum Hemorrhage Postpartum Hemorrhage Pregnancy Complications Puerperal Disorders Urogenital Diseases Uterine Hemorrhage

Age range

17 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Endeavor Health

Evanston, Illinois, 60201, United States

Location status: Recruiting

Location contact

Emmet Hirsch, MD

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ultrasound

Other

Postpartum ultrasound exam

Primary outcomes

  1. Ultrasound exam: uterine measurements

    Time frame: From enrollment to 1.5-2 hours post partum

    • Uterine length (cm)
    • Uterine width (cm)
    • Uterine height (cm)

    These will be correlated with subsequent clinical outcomes, including bleeding events.

  2. Ultrasound exam: endometrial stripe

    Time frame: From enrollment to 1.5-2 hours post partum

    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.

  3. Ultrasound exam:fibroids

    Time frame: From enrollment to 1.5-2 hours post partum

    Presence of uterine fibroids (number and size in cm of each)

    These will be correlated with subsequent clinical outcomes, including bleeding events.

  4. Ultrasound exam: Vagina

    Time frame: From enrollment to 1.5-2 hours post partum

    Caliber of the vagina (cm) (to assess distension by clot)

    These will be correlated with subsequent clinical outcomes, including bleeding events.

  5. Ultrasound exam: Bladder

    Time frame: From enrollment to 1.5-2 hours post partum

    • 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.

Secondary outcomes

  1. Chart review

    Time frame: From enrollment to 6 weeks post partum

    Outcome measures for this study will include details about the postpartum course up to 6 weeks postpartum. This will allow correlation with the results of the ultrasound exam. If patients are re-admitted to the hospital after the delivery discharge, investigators will also collect relevant information about those admissions.

Study contacts

Contact information is provided by the study sponsor or research team.

Kate Honeyfield

CONTACT

[email protected]

847-570-2243

Sponsors and collaborators

Lead sponsor

Endeavor Health

Other

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 27, 2025
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.