High Risk Postpartum Hemorrhage (PPH)NCT04409015
ROTEM® Obstetric Hemorrhage Pilot Study
An observational study of High Risk Postpartum Hemorrhage (PPH), run by Ohio State University at 1 site in United States.
Trial summary
This is a prospective observational study among women at high-risk of postpartum hemorrhage, in their third trimester who are admitted to Labor \&Delivery in spontaneous labor, for induction of labor, or for scheduled cesarean section. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- High Risk Postpartum Hemorrhage (PPH)
- What is being tested?
- ROTEM - rotation thromboelastometry testing
- Type of treatment
- Medical device
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2020to 1 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Study population: Pregnant women with high risk of postpartum hemorrhage
Who may be able to join
- Age ≥ 18 years and able to provide consent
- Gestational age ≥ 34 weeks
- ≥ 1 High-risk of postpartum hemorrhage criteria defined as either of:
- Nulliparous women admitted for induction of labor with unfavorable cervix (Bishop's score <5)
- Prior uterine surgery (> 1 prior cesarean or myomectomy)
- Patients undergoing trial of labor after cesarean delivery
Show all 12Show fewer
- History of postpartum hemorrhage
- ≥4 previous vaginal deliveries
- Multiple gestation
- The presence of > 2 uterine fibroids or fibroid > 5 cm on any ultrasound during the pregnancy
- Planned magnesium sulfate use
- Placenta previa/accreta/increta/percreta
Who cannot join
- Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to sample collection is not an exclusion)
- Antepartum hemorrhage present on admission (>500cc Estimated Blood Loss (EBL))
- Coagulation defects
- Thrombocytopenia with platelets count <100,000
- Enrolled in the "Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean (TXA)" (NCT03364491) study or planned receipt of Tranexamic Acid (TXA) prior to enrollment.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
About this study
This is a prospective observational study among women at high-risk of postpartum hemorrhage, in their third trimester who are admitted to Labor \&Delivery in spontaneous labor, for induction of labor, or for scheduled cesarean section.
- Conditions
- High Risk Postpartum Hemorrhage (PPH)
- Being tested
- ROTEM - rotation thromboelastometry testing
- Keywords
- High risk Postpartum hemorrhage (PPH), ROTEM, pregnant women
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ROTEM - rotation thromboelastometry testingDevice
The ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage.
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.
Measured: After delivery through study completion, an average of 2 years
Secondary outcomes (7)
Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery.
Measured: Pre and post-delivery through study completion, an average of 2 years
Evaluating volume of estimated and quantitative blood loss
Measured: Pre and post-delivery through study completion, an average of 2 years
Evaluating change in hemoglobin/hematocrit ratio between values on admission for delivery (or in the last 4 weeks prior to delivery) and at 24 (+/-4) hours postpartum
Measured: Pre and post-delivery through study completion, an average of 2 years
Evaluating amount of Postpartum hemorrhage defined as Quantitative Blood Loss >500ml for vaginal delivery and >1000ml for cesarean delivery
Measured: Pre and post-delivery through study completion, an average of 2 years
Evaluating frequency of blood transfusion and related morbidities
Measured: Pre and post-delivery through study completion, an average of 2 years
Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock)
Measured: Pre and post-delivery through study completion, an average of 2 years
Evaluating incidence of need for surgical and non-surgical interventions to manage Postpartum hemorrhage (PPH)
Measured: Pre and post-delivery through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2020
- Study start27 Jul 2020
- Primary completion30 Jan 2021
- Study completion1 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk Postpartum Hemorrhage (PPH)Studies of the same condition, open and under way.
- More trials run by Ohio State UniversityThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Cackovic, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04409015
- Sponsor's protocol ID
- 2020H0119
- Status last verified
- Sep 2022
- First submitted
- 26 May 2020
- Last updated
- 21 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- 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 21 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ROTEM® Obstetric Hemorrhage Pilot Study
- ClinicalTrials.gov ID
- NCT04409015
- Acronym / sponsor ID
- 2020H0119
- Conditions
- High Risk Postpartum Hemorrhage (PPH)
- Keywords
- High risk Postpartum hemorrhage (PPH), ROTEM, pregnant women
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 1 Mar 2022 (actual)
- First posted
- 1 Jun 2020 (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.
This is a prospective observational study among women at high-risk of postpartum hemorrhage, in their third trimester who are admitted to Labor \&Delivery in spontaneous labor, for induction of labor, or for scheduled cesarean section.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women with high risk of postpartum hemorrhage
Key inclusion criteria (12 listed)
- Age ≥ 18 years and able to provide consent
- Gestational age ≥ 34 weeks
- ≥ 1 High-risk of postpartum hemorrhage criteria defined as either of:
Key exclusion criteria (5 listed)
- Receipt of anticoagulation (prophylactic anticoagulation stopped 24 hours prior to sample collection is not an exclusion)
- Antepartum hemorrhage present on admission (>500cc Estimated Blood Loss (EBL))
- Coagulation defects
- Thrombocytopenia with platelets count <100,000
- Enrolled in the "Tranexamic Acid for the Prevention of Obstetrical Hemorrhage After Cesarean (TXA)" (NCT03364491) study or planned receipt of Tranexamic Acid (TXA) prior to enrollment.
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 |
|---|---|---|
| ROTEM - rotation thromboelastometry testingThe ROTEM® is a simple blood test that provides information about specific components involved in blood clotting and stopping hemorrhage. | Device | – |
Primary outcome
Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period.
Time frame: After delivery through study completion, an average of 2 years
7 secondary outcomes
Evaluating INTEM, EXTEM and APTEM Clotting time in pre and post-delivery.
Time frame: Pre and post-delivery through study completion, an average of 2 years
Evaluating volume of estimated and quantitative blood loss
Time frame: Pre and post-delivery through study completion, an average of 2 years
Evaluating change in hemoglobin/hematocrit ratio between values on admission for delivery (or in the last 4 weeks prior to delivery) and at 24 (+/-4) hours postpartum
Time frame: Pre and post-delivery through study completion, an average of 2 years
Evaluating amount of Postpartum hemorrhage defined as Quantitative Blood Loss >500ml for vaginal delivery and >1000ml for cesarean delivery
Time frame: Pre and post-delivery through study completion, an average of 2 years
Evaluating frequency of blood transfusion and related morbidities
Time frame: Pre and post-delivery through study completion, an average of 2 years
Evaluating number of severe maternal morbidity (including admission to ICU, intubation, shock)
Time frame: Pre and post-delivery through study completion, an average of 2 years
Evaluating incidence of need for surgical and non-surgical interventions to manage Postpartum hemorrhage (PPH)
Time frame: Pre and post-delivery through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2022.
- Individual participant dataSharing planned: No
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.
The record lists no contact. Use the official record to reach the sponsor.
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 High Risk Postpartum Hemorrhage (PPH), run by Ohio State University 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 12 inclusion and 5 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: finished, as of the sponsor's last update on 21 Sep 2022. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Evaluating degrees of Fibrin polymerization (FIBTEM) ROTEM in the immediate postpartum period. (time frame: After delivery through study completion, an average of 2 years). 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 21 Sep 2022.