- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06351969
Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in Placenta Accreta
Study Overview
Status
Conditions
Detailed Description
PPH remains the most common cause of maternal mortality all over the world
PPH is a serious complication ) is a serious complication of labor and delivery with an incidence of approximately 5-10% and a mortality rate 0.5:1%
PPH can also be a cause of long-term severe morbidity and approximately 12% of women who survive PPH will have severe anaemia A significant percentage of deaths due to PPH can be due to a lack in assessing bleeding amount. Clinically assessing bleeding through inspection underestimates the actual bleeding volume and depending on haemodynamic abnormalities may be to late as effective countermeasures are often not taken in time so identifying pregnant women at risk of PPH prior to delivery is crucial to prevent PPH .
The leading cause of PPH is thought to be uterine atony - the failure of the uterus to contract fully after delivery of the placenta. PPH resulting from uterine atony is a major preventable cause of maternal morbidity and mortality, especially in developing countries .(B-Lynch et al., 2006)
Risk factors for PPH and its main causes, including weak uterine contractions, birth canal lacerations, placental factors, and coagulation abnormalities have been relatively well studied .
However the effect of placental attachment on the thickness of the myometrium and its correlation with PPH is not well studied . By exploring the potential correlation between thinner myometrium at the placenta and a higher incidence of PPH we can reduce mortality occuring with PPH. this study highlight the significance of evaluating the impact of placental attachment on myometrial thickness and placenta thickness in the context of PPH
The study will be carried out on 150 pregnant women, who will undergo delivery at benha university hospital either by vaginal delivery or cesarean section either as elective palnned at operative list or admitted to Obstetrics ER after complete clinical evaluation and decision taken by staff member of Benha gynecology and obstetrics department.
Informed consent will be obtained from all participants prior to commencing the study.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Ahmed A A, resident
- Phone Number: 01005659628
- Email: ahmedupwork42@gmail.com
Study Locations
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Banī Suwayf, Egypt
- B Univeristy
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Benha
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Banha, Benha, Egypt, 13511
- Benha University
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Contact:
- omar khaled naser, lecturer
- Phone Number: 01093826609
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Term pregnancy (37 wk gastation and more )
- Single viable fetus
Exclusion Criteria:
- Severe hematological disorders that could cause abnormal coagulation
- Previous history of PPH
- twins
- Preterm labour
- IUFD
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
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Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in placenta accreta
|
follow up blood loss in ml intraoperative and 24 hour post operative
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ashraf Ismail Mohamed, Professor, benha unviersity
- Study Chair: waleed Mohamed tawfik, Assistant Professor, benha unviersity
- Study Chair: Omar Khaled Naser, Lecturer, benha unviersity
Publications and helpful links
General Publications
- Widmer 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.
- Ononge 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.
- Weeks 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.
- Liao 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.
- B-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
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1111 (Prima Psychiatry internal research fund)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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