Postpartum HemorrhageNCT05127642
Hemostatic Assessment of Postpartum Hemorrhage Using Sonoclot Signature
An observational study of Postpartum Hemorrhage, run by Assiut University at 1 site in Egypt.
Trial summary
Postpartum hemorrhage is the leading cause of maternal morbidity and mortality throughout the world. Rapid diagnosis and early management improve maternal prognosis. Postpartum hemorrhage is defined by a blood loss exceeding 500 ml during the 24 h after delivery. There are many causes of postpartum hemorrhage. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Postpartum Hemorrhage
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2024to 25 Dec 2024
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study will be conducted in Assiut University Hospital, both clinical pathology department and obstetric and gynaecological department.
Who may be able to join
- patients in childbearing period.
- Patients with bleeding occurring in the first 24 hours after delivery (primary postpartum hemorrhage).
- Patients with causes of Postpartum hemorrhage like uterine atony, preeclampsia, blood diseases as inherited and prepartum acquired coagulopathies, and others e.g., acute fatty liver of pregnancy, amniotic fluid embolism, etc.
Who cannot join
- Patients with bleeding after 24 hours from delivery (secondary postpartum hemorrhage).
- Patients with miscarriages (bleeding before 22 weeks of gestation) or Antepartum hemorrhage.
- Traumatic causes of postpartum hemorrhage e.g., rupture uterus, abruptio placenta, Lacerations, hematomas, Uterine inversion, and iatrogenic trauma.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hemostatic Assessment of Postpartum Hemorrhage Cases Using Sonoclot Signature
Postpartum hemorrhage is the leading cause of maternal morbidity and mortality throughout the world. Rapid diagnosis and early management improve maternal prognosis.
Postpartum hemorrhage is defined by a blood loss exceeding 500 ml during the 24 h after delivery.
Read more
There are many causes of postpartum hemorrhage. Most cases develop from uterine atony, which accounts for 75% of cases. Even though there are risk factors for postpartum hemorrhage, it is still an unpredictable obstetric emergency.
Coagulation plays an important role in postpartum hemostasis. Primary and especially secondary coagulation disorders are risk factors for Postpartum hemorrhage.
When bleeding occurs, the decrease in fibrinogen levels is the most rapid change observed among markers of coagulation. Recent studies show that fibrinogen concentration during the initial management of Postpartum hemorrhage is the most informative biological marker for the severity of the hemorrhage.
Various methods are used to record coagulation profile. One of them is estimation by sonoclot.
Viscoelastic hemostatic assays devices (such as sonoclot) have practical advantages as point-of-care devices for monitoring major hemorrhage including a set of parameters that assesses a global coagulation profile like fibrinogen and platelet count.
Identification of coagulopathy by viscoelastic point-of-care testing can be helpful in guiding management of Postpartum hemorrhage and preventing severe maternal outcomes.
- Conditions
- Postpartum Hemorrhage
- Medical subject headings
- Postpartum Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Postpartum hemorrhage patients | Not described | |
| Controls (non postpartum hemorrhage patients) | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Haemostatic assessment in Postpartum haemorrhage Patients using Sonoclot signature.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start1 Dec 2024
- Primary completion1 Dec 2024
- Study completion25 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Postpartum HemorrhageStudies of the same condition, open and under way.
- More trials run by Assiut 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-control
- Time perspective
- Retrospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rehab Abdelnasser Mohammed Omran, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05127642
- Sponsor's protocol ID
- HAOPPHCUSS
- Status last verified
- Mar 2026
- First submitted
- 26 Oct 2021
- Last updated
- 9 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Liew-Spilger AE, Sorg NR, Brenner TJ, Langford JH, Berquist M, Mark NM, Moore SH, Mark J, Baumgartner S, Abernathy MP. Viscoelastic Hemostatic Assays for Postpartum Hemorrhage. J Clin Med. 2021 Aug 31;10(17):3946. doi: 10.3390/jcm10173946.
PubMed 34501395Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. Epub 2009 May 12.
PubMed 19459866Gallos ID, Williams HM, Price MJ, Merriel A, Gee H, Lissauer D, Moorthy V, Tobias A, Deeks JJ, Widmer M, Tuncalp O, Gulmezoglu AM, Hofmeyr GJ, Coomarasamy A. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011689. doi: 10.1002/14651858.CD011689.pub2.
PubMed 29693726Henriquez DDCA, Bloemenkamp KWM, van der Bom JG. Management of postpartum hemorrhage: how to improve maternal outcomes? J Thromb Haemost. 2018 Jun 8. doi: 10.1111/jth.14200. Online ahead of print.
PubMed 29883040Cortet M, Deneux-Tharaux C, Dupont C, Colin C, Rudigoz RC, Bouvier-Colle MH, Huissoud C. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. Br J Anaesth. 2012 Jun;108(6):984-9. doi: 10.1093/bja/aes096. Epub 2012 Apr 6.
PubMed 22490316Benes J, Zatloukal J, Kletecka J. Viscoelastic Methods of Blood Clotting Assessment - A Multidisciplinary Review. Front Med (Lausanne). 2015 Sep 14;2:62. doi: 10.3389/fmed.2015.00062. eCollection 2015.
PubMed 26442265Curry NS, Davenport R, Pavord S, Mallett SV, Kitchen D, Klein AA, Maybury H, Collins PW, Laffan M. The use of viscoelastic haemostatic assays in the management of major bleeding: A British Society for Haematology Guideline. Br J Haematol. 2018 Sep;182(6):789-806. doi: 10.1111/bjh.15524. Epub 2018 Aug 2. No abstract available.
PubMed 30073664
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemostatic Assessment of Postpartum Hemorrhage Cases Using Sonoclot Signature
- ClinicalTrials.gov ID
- NCT05127642
- Acronym / sponsor ID
- HAOPPHCUSS
- Conditions
- Postpartum Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2024 (actual)
- Primary completion
- 1 Dec 2024 (actual)
- Study completion
- 25 Dec 2024 (actual)
- First posted
- 19 Nov 2021 (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.
Postpartum hemorrhage is the leading cause of maternal morbidity and mortality throughout the world. Rapid diagnosis and early management improve maternal prognosis.
Postpartum hemorrhage is defined by a blood loss exceeding 500 ml during the 24 h after delivery.
There are many causes of postpartum hemorrhage. Most cases develop from uterine atony, which accounts for 75% of cases. Even though there are risk factors for postpartum hemorrhage, it is still an unpredictable obstetric emergency.
Coagulation plays an important role in postpartum hemostasis. Primary and especially secondary coagulation disorders are risk factors for Postpartum hemorrhage.
When bleeding occurs, the decrease in fibrinogen levels is the most rapid change observed among markers of coagulation. Recent studies show that fibrinogen concentration during the initial management of Postpartum hemorrhage is the most informative biological marker for the severity of the hemorrhage.
Various methods are used to record coagulation profile. One of them is estimation by sonoclot.
Viscoelastic hemostatic assays devices (such as sonoclot) have practical advantages as point-of-care devices for monitoring major hemorrhage including a set of parameters that assesses a global coagulation profile like fibrinogen and platelet count.
Identification of coagulopathy by viscoelastic point-of-care testing can be helpful in guiding management of Postpartum hemorrhage and preventing severe maternal outcomes.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Postpartum hemorrhage patients | – | – |
| Controls (non postpartum hemorrhage patients) | – | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study will be conducted in Assiut University Hospital, both clinical pathology department and obstetric and gynaecological department.
Key inclusion criteria (3 listed)
- patients in childbearing period.
- Patients with bleeding occurring in the first 24 hours after delivery (primary postpartum hemorrhage).
- Patients with causes of Postpartum hemorrhage like uterine atony, preeclampsia, blood diseases as inherited and prepartum acquired coagulopathies, and others e.g., acute fatty liver of pregnancy, amniotic fluid embolism, etc.
Key exclusion criteria (3 listed)
- Patients with bleeding after 24 hours from delivery (secondary postpartum hemorrhage).
- Patients with miscarriages (bleeding before 22 weeks of gestation) or Antepartum hemorrhage.
- Traumatic causes of postpartum hemorrhage e.g., rupture uterus, abruptio placenta, Lacerations, hematomas, Uterine inversion, and iatrogenic trauma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Haemostatic assessment in Postpartum haemorrhage Patients using Sonoclot signature.
Time frame: 3 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 9 Mar 2026.
- Results publication: PubMed 34501395Liew-Spilger AE, Sorg NR, Brenner TJ, Langford JH, Berquist M, Mark NM, Moore SH, Mark J, Baumgartner S, Abernathy MP. Viscoelastic Hemostatic Assays for Postpartum Hemorrhage. J Clin Med. 2021 Aug 31;10(17):3946. doi: 10.3390/jcm10173946.
- Results publication: PubMed 19459866Huissoud C, Carrabin N, Audibert F, Levrat A, Massignon D, Berland M, Rudigoz RC. Bedside assessment of fibrinogen level in postpartum haemorrhage by thrombelastometry. BJOG. 2009 Jul;116(8):1097-102. doi: 10.1111/j.1471-0528.2009.02187.x. Epub 2009 May 12.
- Results publication: PubMed 29693726Gallos ID, Williams HM, Price MJ, Merriel A, Gee H, Lissauer D, Moorthy V, Tobias A, Deeks JJ, Widmer M, Tuncalp O, Gulmezoglu AM, Hofmeyr GJ, Coomarasamy A. Uterotonic agents for preventing postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2018 Apr 25;4(4):CD011689. doi: 10.1002/14651858.CD011689.pub2.
- Results publication: PubMed 29883040Henriquez DDCA, Bloemenkamp KWM, van der Bom JG. Management of postpartum hemorrhage: how to improve maternal outcomes? J Thromb Haemost. 2018 Jun 8. doi: 10.1111/jth.14200. Online ahead of print.
- Results publication: PubMed 22490316Cortet M, Deneux-Tharaux C, Dupont C, Colin C, Rudigoz RC, Bouvier-Colle MH, Huissoud C. Association between fibrinogen level and severity of postpartum haemorrhage: secondary analysis of a prospective trial. Br J Anaesth. 2012 Jun;108(6):984-9. doi: 10.1093/bja/aes096. Epub 2012 Apr 6.
- Results publication: PubMed 26442265Benes J, Zatloukal J, Kletecka J. Viscoelastic Methods of Blood Clotting Assessment - A Multidisciplinary Review. Front Med (Lausanne). 2015 Sep 14;2:62. doi: 10.3389/fmed.2015.00062. eCollection 2015.
- Results publication: PubMed 30073664Curry NS, Davenport R, Pavord S, Mallett SV, Kitchen D, Klein AA, Maybury H, Collins PW, Laffan M. The use of viscoelastic haemostatic assays in the management of major bleeding: A British Society for Haematology Guideline. Br J Haematol. 2018 Sep;182(6):789-806. doi: 10.1111/bjh.15524. Epub 2018 Aug 2. No abstract available.
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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. 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 Postpartum Hemorrhage, run by Assiut University at 1 site in Egypt.
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 3 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: finished, as of the sponsor's last update on 9 Mar 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 Egypt. 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?
Haemostatic assessment in Postpartum haemorrhage Patients using Sonoclot signature. (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05127642, which also lists 7 linked publications.
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 9 Mar 2026.