Recruiting

Observational Study

Sponsor:

Endeavor Health

Code:

NCT06898034

Conditions

Pregnancy Related

Post Partum Hemorrhage

Eligibility Criteria

Sex: Female

Age: 17+

Healthy Volunteers: Accepted

Interventions

Ultrasound

Study Details

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

Study ID

NCT06898034

Start date

Mar 10, 2025

Status verified date

Mar, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Feb 28, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 17+

Healthy Volunteers: Accepted

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

Enrollment

1725 participants

Anticipated

Interventions and Outcome Measures

Interventions

Ultrasound

Postpartum ultrasound exam

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Locations

Endeavor Health

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Emmet Hirsch, MD

EHirsch@northshore.org

More Information

Sponsor

Endeavor Health

Last update posted

Mar 27, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Endeavor Health on 2025-03-27.