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Blood test may reduce transfusions in severe postpartum bleeding

NCT ID NCT03064152

Knowledge-focused Sponsor: Brigham and Women's Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a rapid blood test called ROTEM can help doctors better manage blood transfusions in women with severe bleeding after childbirth. The test detects early clotting problems, allowing targeted treatment. The goal was to reduce the amount of blood products needed, intensive care stays, and hospital length. The study was terminated early with 49 participants.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

49 people

The number who actually took part.

Started

Sep 2017

Finished

Apr 2020

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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: 1. Cesarean delivery with moderate or high risk for PPH (see below). 2. Cesarean delivery with acute PPH of \> 1000 mL and blood products ordered from the blood bank. 3. 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 * 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 Exclusion Criteria: * 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).

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Conditions

The condition(s) this trial relates to.

Postpartum Hemorrhage

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Postpartum hemorrhage

Contacts and locations

Locations

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.