Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age17+
SponsorEndeavor Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
Preterm delivery
Non-English speaking
Any conditions that impairs potential participants decision making
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Ultrasound
Other interventionPostpartum ultrasound exam
Treatment groups
No treatment groups listed
Trial outcomes
Primary outcomes
1
Ultrasound exam: uterine measurements
* Uterine length (cm) * Uterine width (cm) * Uterine height (cm) These will be correlated with subsequent clinical outcomes, including bleeding events.
Time frame
From enrollment to 1.5-2 hours post partum2
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.
Time frame
From enrollment to 1.5-2 hours post partum3
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.
Time frame
From enrollment to 1.5-2 hours post partum4
Ultrasound exam: Vagina
Caliber of the vagina (cm) (to assess distension by clot) These will be correlated with subsequent clinical outcomes, including bleeding events.
Time frame
From enrollment to 1.5-2 hours post partumSecondary outcomes
1
Chart review
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.
Time frame
From enrollment to 6 weeks post partumSponsors and contacts
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Source ClinicalTrials.gov