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Recruiting NCT06898034

Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage

Observational Pregnancy Related Post Partum Hemorrhage

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound.
Who it may be relevant to
Registry conditions: Pregnancy Related, Post Partum Hemorrhage. Basic parameters: from 17 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Ultrasound
    Postpartum ultrasound exam

Primary outcome measures

  • Ultrasound exam: uterine measurements [Time frame: From enrollment to 1.5-2 hours post partum]
  • Ultrasound exam: endometrial stripe [Time frame: From enrollment to 1.5-2 hours post partum]
  • Ultrasound exam:fibroids [Time frame: From enrollment to 1.5-2 hours post partum]
  • Ultrasound exam: Vagina [Time frame: From enrollment to 1.5-2 hours post partum]
  • Ultrasound exam: Bladder [Time frame: From enrollment to 1.5-2 hours post partum]
Secondary outcome measures (1)
  • Chart review [Time frame: From enrollment to 6 weeks post partum]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Endeavor Health — Evanston

Identifiers

NCT: NCT06898034 · STUDY00000080

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗