Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage

Recruiting

• Conditions: Pregnancy Related; Post Partum Hemorrhage

• Registration Number: NCT06898034
• Lead Sponsor: Endeavor Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-07
• Study Start: 2025-03-10
• Study First Submitted QC: 2025-03-20
• Last Update Submitted: 2025-03-20
• Study First Posted: 2025-03-27
• Last Update Posted: 2025-03-27
• Primary Completion: 2027-02-28
• Study Completion: 2027-03

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 1725

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Ultrasound exam: uterine measurements	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.
Ultrasound exam: Vagina	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.
Ultrasound exam: endometrial stripe	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.
Ultrasound exam:fibroids	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.
Ultrasound exam: Bladder	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 Outcome Measures

Name	Time	Method
Chart review	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.

Trial Locations

Locations (1)

Endeavor Health; 🇺🇸 Evanston, Illinois, United States