Post Partum HemorrhageNCT06351969
Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in Placenta Accreta
An observational study of Post Partum Hemorrhage, run by Benha University at 2 sites in Egypt.
Trial summary
Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placental attachment in the prediction of postpartum hemorrhage in cases of placenta previa accreta and to evaluate both of them as as parameters for identifying high-risk patients. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Post Partum Hemorrhage
- How many people
- 150 participants
- Where
- 2 sitesEgypt
- Study dates
- Jun 2025to Dec 2026
- 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 18 to 50 years
- Women only
- Adult
Study population: The study will be carried out on 100 pregnant women, who will undergo delivery either by vaginal delivery or cesarean section either as elective palnned at operative list or admitted to Obstetrics ER after complete clinical evaluation
Who may be able to join
- Term pregnancy (37 wk gastation and more )
- Single viable fetus
Who cannot join
- Severe hematological disorders that could cause abnormal coagulation
- Previous history of PPH
- twins
- Preterm labour
- IUFD
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt2 sites
Benha University
Banhā, benha, 13511
omar khaled naser, lecturer, 01093826609
B Univeristy
Banī Suwayf
About this study
Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placental attachment in the prediction of postpartum hemorrhage in cases of placenta previa accreta and to evaluate both of them as as parameters for identifying high-risk patients.
- Conditions
- Post Partum Hemorrhage
- Keywords
- Post Partum Hemorrhage, placental thickness, cesarean section, vaginal delivery
- Medical subject headings
- Postpartum Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluating Placental Thickness in cm and Thickness of Uterine Muscle in cm at Placenta Attachment in Prediction of Postpartum Blood Loss in placenta accreta
Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in placenta accreta
Measured: follow up blood loss in ml intraoperative and 24 hour post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study startJun 2025 (estimated)
- Primary completionFeb 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Partum HemorrhageStudies of the same condition, open and under way.
- More trials run by Benha 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelsalam Ahmed Abdelhamid, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06351969
- Sponsor's protocol ID
- 1111
- Status last verified
- Jun 2025
- First submitted
- 28 Mar 2024
- Last updated
- 6 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
PubMed 28456509Widmer M, Piaggio G, Nguyen TMH, Osoti A, Owa OO, Misra S, Coomarasamy A, Abdel-Aleem H, Mallapur AA, Qureshi Z, Lumbiganon P, Patel AB, Carroli G, Fawole B, Goudar SS, Pujar YV, Neilson J, Hofmeyr GJ, Su LL, Ferreira de Carvalho J, Pandey U, Mugerwa K, Shiragur SS, Byamugisha J, Giordano D, Gulmezoglu AM; WHO CHAMPION Trial Group. Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med. 2018 Aug 23;379(8):743-752. doi: 10.1056/NEJMoa1805489. Epub 2018 Jun 27.
PubMed 29949473Ononge S, Mirembe F, Wandabwa J, Campbell OM. Incidence and risk factors for postpartum hemorrhage in Uganda. Reprod Health. 2016 Apr 14;13:38. doi: 10.1186/s12978-016-0154-8.
PubMed 27080710Weeks A. The prevention and treatment of postpartum haemorrhage: what do we know, and where do we go to next? BJOG. 2015 Jan;122(2):202-10. doi: 10.1111/1471-0528.13098. Epub 2014 Oct 7.
PubMed 25289730Liao JB, Buhimschi CS, Norwitz ER. Normal labor: mechanism and duration. Obstet Gynecol Clin North Am. 2005 Jun;32(2):145-64, vii. doi: 10.1016/j.ogc.2005.01.001.
PubMed 15899352B-Lynch, C., Keith, L., Lalonde, A. & Karoshi, M. (2006). A textbook of postpartum haemorrhage: a comprehensive guide to evaluation,managementand surgical intervention, New Delhi, India, Japee Brothers
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in Placenta Accreta
- ClinicalTrials.gov ID
- NCT06351969
- Acronym / sponsor ID
- 1111
- Conditions
- Post Partum Hemorrhage
- Keywords
- Post Partum Hemorrhage, placental thickness, cesarean section, vaginal delivery
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- Jun 2025 (estimated)
- Primary completion
- Feb 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Apr 2024 (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.
Aim of the Work is To determine the significance of the placental thickness and the thickness of the uterine muscle layer at placental attachment in the prediction of postpartum hemorrhage in cases of placenta previa accreta and to evaluate both of them as as parameters for identifying high-risk patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- The study will be carried out on 100 pregnant women, who will undergo delivery either by vaginal delivery or cesarean section either as elective palnned at operative list or admitted to Obstetrics ER after complete clinical evaluation
Key inclusion criteria (2 listed)
- Term pregnancy (37 wk gastation and more )
- Single viable fetus
Key exclusion criteria (5 listed)
- Severe hematological disorders that could cause abnormal coagulation
- Previous history of PPH
- twins
- Preterm labour
- IUFD
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
Evaluating Placental Thickness in cm and Thickness of Uterine Muscle in cm at Placenta Attachment in Prediction of Postpartum Blood Loss in placenta accreta
Time frame: follow up blood loss in ml intraoperative and 24 hour post operative
Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in placenta accreta
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 6 Jun 2025.
- Background: PubMed 28456509WOMAN Trial Collaborators. Effect of early tranexamic acid administration on mortality, hysterectomy, and other morbidities in women with post-partum haemorrhage (WOMAN): an international, randomised, double-blind, placebo-controlled trial. Lancet. 2017 May 27;389(10084):2105-2116. doi: 10.1016/S0140-6736(17)30638-4. Epub 2017 Apr 26.
- Background: PubMed 29949473Widmer M, Piaggio G, Nguyen TMH, Osoti A, Owa OO, Misra S, Coomarasamy A, Abdel-Aleem H, Mallapur AA, Qureshi Z, Lumbiganon P, Patel AB, Carroli G, Fawole B, Goudar SS, Pujar YV, Neilson J, Hofmeyr GJ, Su LL, Ferreira de Carvalho J, Pandey U, Mugerwa K, Shiragur SS, Byamugisha J, Giordano D, Gulmezoglu AM; WHO CHAMPION Trial Group. Heat-Stable Carbetocin versus Oxytocin to Prevent Hemorrhage after Vaginal Birth. N Engl J Med. 2018 Aug 23;379(8):743-752. doi: 10.1056/NEJMoa1805489. Epub 2018 Jun 27.
- Background: PubMed 27080710Ononge S, Mirembe F, Wandabwa J, Campbell OM. Incidence and risk factors for postpartum hemorrhage in Uganda. Reprod Health. 2016 Apr 14;13:38. doi: 10.1186/s12978-016-0154-8.
- Background: PubMed 25289730Weeks A. The prevention and treatment of postpartum haemorrhage: what do we know, and where do we go to next? BJOG. 2015 Jan;122(2):202-10. doi: 10.1111/1471-0528.13098. Epub 2014 Oct 7.
- Background: PubMed 15899352Liao JB, Buhimschi CS, Norwitz ER. Normal labor: mechanism and duration. Obstet Gynecol Clin North Am. 2005 Jun;32(2):145-64, vii. doi: 10.1016/j.ogc.2005.01.001.
- BackgroundB-Lynch, C., Keith, L., Lalonde, A. & Karoshi, M. (2006). A textbook of postpartum haemorrhage: a comprehensive guide to evaluation,managementand surgical intervention, New Delhi, India, Japee Brothers
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Partum Hemorrhage, run by Benha University at 2 sites 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 2 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: opening soon, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
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 Ahmed A A, resident (01005659628, ahmedupwork42@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluating Placental Thickness in cm and Thickness of Uterine Muscle in cm at Placenta Attachment in Prediction of Postpartum Blood Loss in placenta accreta (time frame: follow up blood loss in ml intraoperative and 24 hour post operative). 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 NCT06351969, which also lists 6 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 6 Jun 2025.