Clinical trial NCT06351969: Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in Placenta Accreta
Official title: Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in Placenta Accreta
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Post Partum Hemorrhage
Keywords: Post Partum Hemorrhage
placental thickness
cesarean section
vaginal delivery
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-04-08
Enrollment: 150
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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

Brief 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.


Eligibility criteria: 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

Primary outcomes:
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
timeFrame: follow up blood loss in ml intraoperative and 24 hour post operative
Secondary outcomes:
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Benha University
state: Benha
city: Banī Suwayf
country: Egypt
facility: B Univeristy
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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