Pregnancy RelatedNCT06898034
Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
An observational study of Pregnancy Related and Post Partum Hemorrhage, run by Endeavor Health at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 17 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pregnancy Related, Post Partum Hemorrhage
- What is being tested?
- Ultrasound
- How many people
- 1,725 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2025to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study 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.
Who may be able to join
- 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
Who cannot join
- Preterm delivery
- Non-English speaking
- Any conditions that impairs potential participants decision making
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Endeavor Health
Evanston, Illinois, 60201
Emmet Hirsch, MD, EHirsch@northshore.org
About this study
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
- Being tested
- Ultrasound
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundOther
Postpartum ultrasound exam
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound exam: uterine measurements
- Uterine length (cm)
- Uterine width (cm)
- Uterine height (cm)
These will be correlated with subsequent clinical outcomes, including bleeding events.
Measured: From enrollment to 1.5-2 hours post partum
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.
Measured: From enrollment to 1.5-2 hours post partum
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.
Measured: From enrollment to 1.5-2 hours post partum
Ultrasound exam: Vagina
Caliber of the vagina (cm) (to assess distension by clot)
These will be correlated with subsequent clinical outcomes, including bleeding events.
Measured: From enrollment to 1.5-2 hours post partum
Ultrasound exam: Bladder
- 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.
Measured: From enrollment to 1.5-2 hours post partum
Secondary 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.
Measured: From enrollment to 6 weeks post partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2025
- Study start10 Mar 2025
- Primary completion28 Feb 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pregnancy RelatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,725 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Endeavor Health
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmet Hirsch, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06898034
- Sponsor's protocol ID
- STUDY00000080
- Status last verified
- Mar 2025
- First submitted
- 7 Mar 2025
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Ultrasound Evaluation to Assess Risk of Hemorrhage
- ClinicalTrials.gov ID
- NCT06898034
- Acronym / sponsor ID
- STUDY00000080
- Conditions
- Pregnancy Related, Post Partum Hemorrhage
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,725 participants (estimated)
- Lead sponsor
- Endeavor HealthUniversity, hospital or other
- Study start
- 10 Mar 2025 (actual)
- Primary completion
- 28 Feb 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 27 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 17 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Preterm delivery
- Non-English speaking
- Any conditions that impairs potential participants decision making
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundPostpartum ultrasound exam | Other | – |
Primary outcome
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.
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.
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.
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.
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.
1 secondary outcome
Chart review
Time frame: From enrollment to 6 weeks post partum
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy Related and Post Partum Hemorrhage, run by Endeavor Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kate Honeyfield (847-570-2243, KHoneyfield@northshore.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ultrasound exam: uterine measurements (time frame: From enrollment to 1.5-2 hours post partum). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2025.