Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-04-11 @ 3:06 PM
Study NCT ID:
NCT05802251
Status:
RECRUITING
Last Update Posted:
2024-07-30
First Post:
2023-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010923', 'term': 'Placenta Previa'}], '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': 'D010922', 'term': 'Placenta Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 68}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-29', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-04-05', 'lastUpdatePostDateStruct': {'date': '2024-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'maternal bleeding rate', 'timeFrame': 'till delivery', 'description': 'number of attacks of antepartum hemorrhage'}], 'secondaryOutcomes': [{'measure': 'Blood transfusion', 'timeFrame': 'till delivery 36 to 37 weeks', 'description': 'number of PRBCs'}, {'measure': 'Emergency Cesarean section', 'timeFrame': 'till delivery 36 to 37 weeks', 'description': 'severe antepartum hemorrhage requiring delivery'}, {'measure': 'Premature delivery', 'timeFrame': "37 week's gestation", 'description': "before the planned delivery date (before 37 weeks' gestation)"}, {'measure': 'Need for cesarean hysterectomy', 'timeFrame': 'during cesarean section', 'description': 'cesarean hysterectomy due to bleeding or placenta accreta spectrum'}, {'measure': 'Postpartum hemorrhage', 'timeFrame': 'Within 2 hours of delivery', 'description': 'severity of attacks and required further management or blood transfusion'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Previa']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the effectiveness of ultrasonographic parameters (cervical length, placental thickness and distance placental edge from internal os of the cervix) in predicting the risk of antepartum hemorrhage and emergency cesarean delivery in asymptomatic women with placenta previa.', 'detailedDescription': 'The incidence of placenta previa is 3-5 per 1000 pregnancies worldwide and is still rising because of increased maternal age, parity, cesarean section rates, assisted reproductive technology, maternal smoking with the widespread use of transvaginal ultrasound. antepartum hemorrhage is an important cause of maternal and neonatal morbidity and mortality in pregnant women with placenta previa. However, the epidemiological characteristics are not completely understood. this study aims at evaluating the sonographic findings in asymptomatic women with placenta previa as cervical length, placenta thickness and distance from cervix to placental edge to recommend management for in-patients versus out-patient antenatal care and early planned hospital admission and delivery for women at high risk of antepartum hemorrhage and preterm cesarean section and hysterectomy for life threatening antepartum hemorrhage.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Asymptomatic pregnant women diagnosed with placenta previa between 28 to 37 weeks' gestation.", 'genderDescription': 'pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Asymptomatic women diagnosed with placenta previa according to RCOG (GTG No. 27a, 2018): placenta lies directly over the internal os for pregnancies more than 16 weeks' gestation on transabdominal or transvaginal scanning.\n* Gestational age between 28 till 37 weeks' gestation (as delivery should be considered between 36 and 37 weeks of gestation for women presenting with uncomplicated placenta previa)\n\nExclusion Criteria:\n\n* Multiple pregnancies.\n* Threatened preterm labor or preterm rupture of membranes.\n* History of bleeding in the current pregnancy.\n* Polyhydraminos (AFI \\> 25 cm).\n* History of cervical surgery (cone biopsy).\n* Presence of cervical cerclage.\n* Maternal use of vaginla progesterone.\n* History of maternal disease (hypertensive, DM, Cardiac).\n* Fetal malformation or growth restriction"}, 'identificationModule': {'nctId': 'NCT05802251', 'briefTitle': 'Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Sonographic Parameters and Risk of Antepartum Hemorrhage in Asymptomatic Women With Placenta Previa: A Cohort Study', 'orgStudyIdInfo': {'id': 'MD 172 2022'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasonographic parameters', 'type': 'DIAGNOSTIC_TEST', 'description': 'cervical length. placental thickness. distance placental edge from internal os of the cervix'}]}, 'contactsLocationsModule': {'locations': [{'zip': '11591', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Ayman Abulnor, MD', 'role': 'CONTACT', 'email': 'aymanabulnour@gmail.com', 'phone': '01223414990'}], 'facility': 'Faculty of Medicine, Ain Shams University', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Maya Abdelrazek, MD', 'role': 'CONTACT', 'email': 'dr_maya89@med.asu.edu.eg', 'phone': '01222393983'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Maya Abdelrazek', 'investigatorAffiliation': 'Ain Shams University'}}}}