Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-03 @ 4:58 AM
Study NCT ID:
NCT03273569
Status:
UNKNOWN
Last Update Posted:
2017-09-06
First Post:
2017-08-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PDIUC Protocol for Placental Accreta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010921', 'term': 'Placenta Accreta'}], '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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Women with placenta accreta at the time of Cesarean delivery'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2018-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-09-04', 'studyFirstSubmitDate': '2017-08-05', 'studyFirstSubmitQcDate': '2017-09-04', 'lastUpdatePostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine conservation', 'timeFrame': 'Intra-operative (during the time of Cesarean delivery)', 'description': 'Successive Uterine conservation; no peripartum hysterectomy needed'}], 'secondaryOutcomes': [{'measure': 'Primary postpartum hemorrhage', 'timeFrame': 'From delivery of the fetus to 1 hour after delivery of the fetus', 'description': 'Amount of postpartum bleeding \\> 1000 ml'}, {'measure': 'Severe primary postpartum hemorrhage', 'timeFrame': 'From delivery of the fetus to 1 hour after delivery of the fetus', 'description': 'Amount of postpartum bleeding \\> 1500 ml'}, {'measure': 'Bladder injury', 'timeFrame': 'Intra-operative (during the time of Cesarean delivery)', 'description': 'Incidental injury of the bladder during delivery of the placenta or control of bleeding'}, {'measure': 'Bowel injury', 'timeFrame': 'Intra-operative (during the time of Cesarean delivery)', 'description': 'Incidental injury of the bladder during delivery of the placenta or control of bleeding'}, {'measure': 'Surgical site infection', 'timeFrame': 'Up to 2 weeks after Cesarean delivery', 'description': 'Cesarean wound infection'}, {'measure': 'Drop in hemoglobin level', 'timeFrame': 'Hemoglobin is checked 1 hour prior to Cesarean delivery and again postoperative (24 and 72 hours after Cesarean delivery)', 'description': 'Change in hemoglobin before and more than 24 hours after delivery'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Accreta']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate a novel protocol to conserve the uterus during Cesarean delivery indicated for placenta accreta.', 'detailedDescription': 'Placenta accreta is a morbid obstetric condition that describes variable non-physiologic invasion of the placenta into the the uterine wall. The incidence of placenta accreta, as a serious cause of postpartum hemorrhage, has substantially increased secondary to increase the rate of Cesarean delivery. Placenta accreta is primarily managed by peripartum hysterectomy prior to delivery of the placenta to avoid uncontrolled bleeding. However, in addition to the surgical risks, hysterectomy is psychologically morbid to many women particularly younger women and women with low parity. Therefore, several conservative options were studied to provide an alternative for hysterectomy in these women. Our study is designated to evaluate a proposed protocol of multi-step interventions to reduce the anticipated amount of bleeding prior to delivery of the placenta.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with diagnosis of placenta accreta (US or MRI based diagnosis)\n* Women who decline hysterectomy\n* Pregnancy at 28 weeks of gestation or beyond\n* Women who accept to participate in the study\n\nExclusion Criteria:\n\n* Emergency Cesarean delivery (women with active bleeding)\n* Women with cardiac diseases\n* Women with coagulopathy'}, 'identificationModule': {'nctId': 'NCT03273569', 'acronym': 'PDIUC', 'briefTitle': 'PDIUC Protocol for Placental Accreta', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Preplacental Delivery Intervention for Uterine Conservation Protocol: a Novel Approach for Management of Placenta Accreta', 'orgStudyIdInfo': {'id': 'PDIUC001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Women with placenta accreta', 'description': 'PDI-UC protocol', 'interventionNames': ['Procedure: PDI-UC protocol']}], 'interventions': [{'name': 'PDI-UC protocol', 'type': 'PROCEDURE', 'description': 'Preplacental delivery intervention for uterine conservation protocol starts after delivery of the fetus during Cesarean delivery and consists of delayed cord clamping, intramyometrial injection of vasopressin, subdecidual injection of saline, ligation of the uterine arteries, multiple 8 compression sutures, followed by delivery of the placenta, application of pressure and interrupted sutures if needed', 'armGroupLabels': ['Women with placenta accreta']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Sherif Shazly, MBBCh, MSc', 'role': 'CONTACT', 'email': 'sherify2k2@gmail.com', 'phone': '+15075131392'}, {'name': 'Ahmed Abbas, MBBCh, MD', 'role': 'CONTACT', 'email': 'bmr90@hotmail.com', 'phone': '+201003385183'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant lecturer, OBGYN department; principal investigator', 'investigatorFullName': 'Sherif Abdelkarim Mohammed Shazly', 'investigatorAffiliation': 'Assiut University'}}}}