Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-25 @ 8:34 PM
Study NCT ID:
NCT06351969
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-06
First Post:
2024-03-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in Placenta Accreta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-03', 'studyFirstSubmitDate': '2024-03-28', 'studyFirstSubmitQcDate': '2024-04-04', 'lastUpdatePostDateStruct': {'date': '2025-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'description': 'Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in placenta accreta'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Post Partum Hemorrhage', 'placental thickness', 'cesarean section', 'vaginal delivery'], 'conditions': ['Post Partum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '28456509', 'type': 'BACKGROUND', '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.'}, {'pmid': '29949473', 'type': 'BACKGROUND', '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.'}, {'pmid': '27080710', 'type': 'BACKGROUND', '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.'}, {'pmid': '25289730', 'type': 'BACKGROUND', '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.'}, {'pmid': '15899352', 'type': 'BACKGROUND', '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.'}, {'type': 'BACKGROUND', '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'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Term pregnancy (37 wk gastation and more )\n* Single viable fetus\n\nExclusion Criteria:\n\n* Severe hematological disorders that could cause abnormal coagulation\n* Previous history of PPH\n* twins\n* Preterm labour\n* IUFD'}, 'identificationModule': {'nctId': 'NCT06351969', 'briefTitle': 'Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in Placenta Accreta', 'organization': {'class': 'OTHER', 'fullName': 'Benha University'}, 'officialTitle': 'Evaluating Placental Thickness and Thickness of Uterine Muscle at Placenta Attachment in Prediction of Postpartum Blood Loss in Placenta Accreta', 'orgStudyIdInfo': {'id': '1111'}}, 'contactsLocationsModule': {'locations': [{'zip': '13511', 'city': 'Banhā', 'state': 'benha', 'country': 'Egypt', 'contacts': [{'name': 'omar khaled naser, lecturer', 'role': 'CONTACT', 'phone': '01093826609'}], 'facility': 'Benha University', 'geoPoint': {'lat': 30.45977, 'lon': 31.1842}}, {'city': 'Banī Suwayf', 'country': 'Egypt', 'facility': 'B Univeristy', 'geoPoint': {'lat': 29.07441, 'lon': 31.09785}}], 'centralContacts': [{'name': 'Ahmed A A, resident', 'role': 'CONTACT', 'email': 'ahmedupwork42@gmail.com', 'phone': '01005659628'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benha University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ahmed Abdelsalam Ahmed Abdelhamid', 'investigatorAffiliation': 'Benha University'}}}}