Postpartum HemorrhageNCT03064152
Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
A study testing Rotational Thromboelastometry in people with Postpartum Hemorrhage, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The aim of this study is to evaluate the impact of a rotational thromboelastometry (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or cesarean delivery. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Hemorrhage
- What is being tested?
- Rotational Thromboelastometry
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2017to 1 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologists (ASA) II or III health status (minimal to no systemic disease), age between 18 and 50 yrs, singleton pregnancies admitted for labor and delivery anticipated or actual PPH, or anticipated transfusion of blood products. This will be defined by one or more of the following eligibility criteria:
- Cesarean delivery with moderate or high risk for PPH (see below).
- Cesarean delivery with acute PPH of > 1000 mL and blood products ordered from the blood bank.
- Vaginal delivery with acute PPH of > 500 mL and blood products ordered from the blood bank.
- For criterion #1, moderate risk for PPH is defined by one or more of the following features:
- prior cesarean delivery in labor
Show all 17Show fewer
- prior cesarean delivery with known adhesive disease of the placenta
- multiple gestation
- >4 previous vaginal births
- chorioamnionitis with maternal temperature > 101 degrees Fahrenheit
- history of previous PPH
- large uterine fibroids (> 5 cm)
- second stage of labor (10cm cervical dilation to delivery) > 3 hours
- High risk for postpartum hemorrhage is defined by one or more of the following features:
- suspected placenta accreta by pre-delivery ultrasound findings
- placenta previa (current or resolved within 4 weeks of delivery) or low-lying placenta
- active bleeding on admission prior to delivery
Who cannot join
- known coagulation defect prior to delivery including inherited (hemophilia A, von Willebrand disease, thrombocytopenia, other) or iatrogenic causes (anticoagulation therapy), refusal to accept blood transfusion (Jehovah's Witness, other).
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The aim of this study is to evaluate the impact of a rotational thromboelastometry (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or cesarean delivery. Maternal transfusion requirement, quantitative blood loss (QBL), need for intensive care unit (ICU) admission, and length of hospital stay will be evaluated. The utilization of ROTEM® for transfusion management will identify patients who develop early coagulation changes such as hypofibrinogenemia or disseminated intravascular coagulation. Our hypothesis is that earlier identification and directed therapy of such coagulation changes will lower overall transfusion requirement (packed red blood cells, fresh frozen plasma, fibrinogen concentrate, cryoprecipitate, or other product), reduce the need for ICU admission, and shorten length of hospital stay. A cost analysis will be performed.
Read the detailed description
Postpartum hemorrhage is increasing in incidence in the United States, renewing interest in targeted approaches to transfusion during cesarean delivery. ROTEM-based transfusion for PPH has been advocated as a mechanism to lower overall requirement of blood components transfused and lower the incidence of transfusion-associated pulmonary morbidity in a small study of women undergoing cesarean delivery. However, larger-scale randomized evaluation of this transfusion approach is warranted for women who experience hemorrhage after vaginal or cesarean delivery. A lower serum fibrinogen level (< 200 mg/dL) at the onset of PPH has a positive predictive value of 100% for progression to severe PPH. However, serum fibrinogen testing has a turnaround time of one hour and is therefore not useful for acute management of PPH. ROTEM provides point-of-care results that have been validated as surrogate markers for serum fibrinogen, within 10 minutes. However, whether ROTEM data alters empiric management of acute PPH is unknown. A comparison of transfusion management decisions and costs incurred for transfused products and transfusion-related morbidity (duration of hospitalization, intensive care unit, respiratory complications) will be performed.
- Conditions
- Postpartum Hemorrhage
- Being tested
- Rotational Thromboelastometry
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotational ThromboelastometryDevice
Also called ROTEM
ROTEM is a point-of-care coagulation assay.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results. |
| ROTEM | Experimental | Patients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH. Receives: Device: Rotational Thromboelastometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Blood Products Transfused Within 48h of Onset of PPH
Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units within 48h of onset of PPH
Measured: t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.
Secondary outcomes (4)
Blood Loss
Visual estimate in suction canister and sponges, or quantitative blood loss
Measured: From the onset of PPH through 4 hours from leaving the operating room or within 4 hours from the last blood transfusion, whichever occurs later and on average 5 hours.
Number of Participants With Admission to the Intensive Care Unit
Number of participants needing admission to the intensive care unit within 2 weeks of delivery
Measured: within 2 weeks of delivery
Number of Participants Who Required a Hysterectomy
Number of participants who required a hysterectomy to control postpartum hemorrhage.
Measured: within 2 weeks of delivery
Number of Participants Who Experienced Maternal Mortality
Number of participants who experienced maternal death after delivery.
Measured: within 2 weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start1 Sep 2017
- Primary completion7 Feb 2020
- Study completion1 Apr 2020
Why it stopped: slow enrollment, outcome measures collected but actual enrollment is below target enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michaela Kristina Farber, MD, Brigham and Women's Hospital
- Investigators
- Michaela K Farber, MD MS, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064152
- Sponsor's protocol ID
- 2016P001800
- Status last verified
- Dec 2025
- First submitted
- 17 Feb 2017
- Last updated
- 16 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotational Thromboelastometry for the Transfusion Management of Postpartum Hemorrhage After Vaginal or Cesarean Delivery
- ClinicalTrials.gov ID
- NCT03064152
- Acronym / sponsor ID
- 2016P001800
- Conditions
- Postpartum Hemorrhage
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: slow enrollment, outcome measures collected but actual enrollment is below target enrollment
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 7 Feb 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Posted 18 Jun 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of this study is to evaluate the impact of a rotational thromboelastometry (ROTEM®)-based transfusion protocol during postpartum hemorrhage (PPH) after vaginal or cesarean delivery. Maternal transfusion requirement, quantitative blood loss (QBL), need for intensive care unit (ICU) admission, and length of hospital stay will be evaluated. The utilization of ROTEM® for transfusion management will identify patients who develop early coagulation changes such as hypofibrinogenemia or disseminated intravascular coagulation. Our hypothesis is that earlier identification and directed therapy of such coagulation changes will lower overall transfusion requirement (packed red blood cells, fresh frozen plasma, fibrinogen concentrate, cryoprecipitate, or other product), reduce the need for ICU admission, and shorten length of hospital stay. A cost analysis will be performed.
Detailed description
Postpartum hemorrhage is increasing in incidence in the United States, renewing interest in targeted approaches to transfusion during cesarean delivery. ROTEM-based transfusion for PPH has been advocated as a mechanism to lower overall requirement of blood components transfused and lower the incidence of transfusion-associated pulmonary morbidity in a small study of women undergoing cesarean delivery. However, larger-scale randomized evaluation of this transfusion approach is warranted for women who experience hemorrhage after vaginal or cesarean delivery. A lower serum fibrinogen level (< 200 mg/dL) at the onset of PPH has a positive predictive value of 100% for progression to severe PPH. However, serum fibrinogen testing has a turnaround time of one hour and is therefore not useful for acute management of PPH. ROTEM provides point-of-care results that have been validated as surrogate markers for serum fibrinogen, within 10 minutes. However, whether ROTEM data alters empiric management of acute PPH is unknown. A comparison of transfusion management decisions and costs incurred for transfused products and transfusion-related morbidity (duration of hospitalization, intensive care unit, respiratory complications) will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients who experience postpartum hemorrhage will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, activated partial thromboplastin time (aPTT), fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the control group will be blinded to ROTEM results. |
| ROTEM | Experimental | Device: Rotational ThromboelastometryPatients will receive standard of care for labor and delivery, cesarean delivery, and postpartum care. Transfusion will be based on standard of care utilizing clinical criteria of hemodynamics (noninvasive blood pressure, heart rate, arterial line if deemed clinically useful) and coagulation labs (PT, aPTT, fibrinogen, complete blood count). In addition to standard of care, additional ROTEM blood assays will be performed at any time routine coagulation labs are sent. Providers in the ROTEM group will receive real-time ROTEM results and a previously validated ROTEM-based transfusion algorithm for PPH. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- American Society of Anesthesiologists (ASA) II or III health status (minimal to no systemic disease), age between 18 and 50 yrs, singleton pregnancies admitted for labor and delivery anticipated or actual PPH, or anticipated transfusion of blood products. This will be defined by one or more of the following eligibility criteria:
- For criterion #1, moderate risk for PPH is defined by one or more of the following features:
- prior cesarean delivery in labor
- prior cesarean delivery with known adhesive disease of the placenta
- multiple gestation
Key exclusion criteria (1 listed)
- known coagulation defect prior to delivery including inherited (hemophilia A, von Willebrand disease, thrombocytopenia, other) or iatrogenic causes (anticoagulation therapy), refusal to accept blood transfusion (Jehovah's Witness, other).
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 |
|---|---|---|
| Rotational ThromboelastometryAlso: ROTEMROTEM is a point-of-care coagulation assay. | Device | ROTEM |
Primary outcome
Total Blood Products Transfused Within 48h of Onset of PPH
Time frame: t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.
Total number of packed red blood cells (PRBCs), fresh frozen plasma (FFP), platelets, cryoprecipitate, cell salvage units within 48h of onset of PPH
4 secondary outcomes
Blood Loss
Time frame: From the onset of PPH through 4 hours from leaving the operating room or within 4 hours from the last blood transfusion, whichever occurs later and on average 5 hours.
Number of Participants With Admission to the Intensive Care Unit
Time frame: within 2 weeks of delivery
Number of Participants Who Required a Hysterectomy
Time frame: within 2 weeks of delivery
Number of Participants Who Experienced Maternal Mortality
Time frame: within 2 weeks of delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Postpartum Hemorrhage
Not yet recruiting
Comparison of Effect of Two Different Doses of Intravenous Oxytocin on Patients Undergoing Elective Cesarean Section
Postpartum Hemorrhage, Uterine Atony
RecruitingPhase 3
Tranexamic Acid to Prevent Heavy Bleeding After Childbirth in Women at Higher Risk
Postpartum Hemorrhage
Not yet recruitingObservational study
Measured Versus Hemoglobin-Calculated Postpartum Blood Loss in Waterbirth
Postpartum Hemorrhage, Waterbirth
RecruitingObservational study
Long Term Outcome After Use of Vacuum-induced Tamponade for Postpartum Hemorrhage
Postpartum Hemorrhage, Treatment Outcome
RecruitingPhase 2
Prevention of Postpartum Hemorrhage With Tranexamic Acid
Post Partum Hemorrhage
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. This study is not recruiting at the moment.
Michaela K Farber, MD MS principal investigator
Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rotational Thromboelastometry in people with Postpartum Hemorrhage, run by Brigham and Women's Hospital 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 17 inclusion and 1 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: stopped early, as of the sponsor's last update on 16 Jan 2026. 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?
Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Blood Products Transfused Within 48h of Onset of PPH (time frame: t0 = diagnosis of PPH by criteria defined; t final = 48h after onset of PPH.). 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 16 Jan 2026.