Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2026-02-24 @ 12:13 AM
Study NCT ID:
NCT05419804
Status:
COMPLETED
Last Update Posted:
2024-01-31
First Post:
2022-05-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 57}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2023-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-30', 'studyFirstSubmitDate': '2022-05-30', 'studyFirstSubmitQcDate': '2022-06-11', 'lastUpdatePostDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Success of procedure', 'timeFrame': '1year', 'description': 'Success of procedure regarding ability to preserve the uterus and stoppage of bleeding.\n\nThe bleeding will be evaluated by haemoglobin level preoperative and postoperative.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Placenta Accreta']}, 'referencesModule': {'references': [{'pmid': '32839166', 'type': 'BACKGROUND', 'citation': 'Bloomfield V, Rogers S, Leyland N. Placenta accreta spectrum. CMAJ. 2020 Aug 24;192(34):E980. doi: 10.1503/cmaj.200304. No abstract available.'}, {'pmid': '31469990', 'type': 'BACKGROUND', 'citation': 'Zuckerwise LC, Craig AM, Newton JM, Zhao S, Bennett KA, Crispens MA. Outcomes following a clinical algorithm allowing for delayed hysterectomy in the management of severe placenta accreta spectrum. Am J Obstet Gynecol. 2020 Feb;222(2):179.e1-179.e9. doi: 10.1016/j.ajog.2019.08.035. Epub 2019 Aug 27.'}, {'pmid': '31578123', 'type': 'BACKGROUND', 'citation': 'Pinas Carrillo A, Chandraharan E. Placenta accreta spectrum: Risk factors, diagnosis and management with special reference to the Triple P procedure. Womens Health (Lond). 2019 Jan-Dec;15:1745506519878081. doi: 10.1177/1745506519878081.'}, {'pmid': '23466142', 'type': 'BACKGROUND', 'citation': 'Wortman AC, Alexander JM. Placenta accreta, increta, and percreta. Obstet Gynecol Clin North Am. 2013 Mar;40(1):137-54. doi: 10.1016/j.ogc.2012.12.002.'}, {'pmid': '30471891', 'type': 'BACKGROUND', 'citation': 'Society of Gynecologic Oncology; American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine; Cahill AG, Beigi R, Heine RP, Silver RM, Wax JR. Placenta Accreta Spectrum. Am J Obstet Gynecol. 2018 Dec;219(6):B2-B16. doi: 10.1016/j.ajog.2018.09.042.'}, {'pmid': '32778495', 'type': 'BACKGROUND', 'citation': 'Fonseca A, Ayres de Campos D. Maternal morbidity and mortality due to placenta accreta spectrum disorders. Best Pract Res Clin Obstet Gynaecol. 2021 Apr;72:84-91. doi: 10.1016/j.bpobgyn.2020.07.011. Epub 2020 Jul 20.'}, {'pmid': '30142668', 'type': 'BACKGROUND', 'citation': 'Biyik I, Keskin F, Keskin EU. Conservative Surgical Treatment of a Case of Placenta Accreta. Rev Bras Ginecol Obstet. 2018 Aug;40(8):494-496. doi: 10.1055/s-0038-1668528. Epub 2018 Aug 24.'}, {'pmid': '30204620', 'type': 'BACKGROUND', 'citation': 'Haunschild C, Yeaton-Massey A, Lyell DJ. Antenatal Management of Placenta Accreta. Clin Obstet Gynecol. 2018 Dec;61(4):766-773. doi: 10.1097/GRF.0000000000000394.'}, {'pmid': '31615304', 'type': 'BACKGROUND', 'citation': 'Abo-Elroose AA, Ahmed MR, Shaaban MM, Ghoneim HM, Mohamed TY. Triple P with T-shaped lower segment suture; an effective novel alternative to hysterectomy in morbidly adherent anterior placenta previa. J Matern Fetal Neonatal Med. 2021 Oct;34(19):3187-3191. doi: 10.1080/14767058.2019.1678145. Epub 2019 Oct 15.'}, {'pmid': '30486635', 'type': 'BACKGROUND', 'citation': "Di Mascio D, Cali G, D'antonio F. Updates on the management of placenta accreta spectrum. Minerva Ginecol. 2019 Apr;71(2):113-120. doi: 10.23736/S0026-4784.18.04333-2. Epub 2018 Nov 27."}]}, 'descriptionModule': {'briefSummary': 'To study feasibility and safety of Total lower uterine segmentectomy with cervico-corporeal anastomosis in conservative management of placenta accreta', 'detailedDescription': 'Placenta accreta represents a real challenge in modern obstetric care as its incidence is increasing in a parallelism with increased CSs rates. Its management represents another challenge and a multidisciplinary team with clear plans and alternative strategies that fulfill different situation and address different patient needs must be clearly settled in every referral center dealing with placenta accreta.\n\nHysterectomy without trials of placental separation seems to be the standard and logical procedure. However hysterectomy needs to be a total or at least including the entire invaded Lower uterine segment. Hysterectomy is associated with significant blood loss, and loss of future fertility. There are several fertility conservation approaches with variable success rates, complications, technical demands and costs.\n\nUterine plication sutures has been reported as successful uterine conservation strategy but subsequent intrauterine adhesions, weak uterine scar and uterine necrosis might culminate in a functionless uterus.\n\nThe present work describes total lower uterine segmentectomy with cervical-corporeal anastomosis as a relatively less invasive uterine conservation strategy with minimization of blood loss and transfusion needs. Furthermore, total lower uterine segmentectomy with cervico-corporeal anastomosis has the merits of leaving behind a strong scar and a well-functioning uterus.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, planned and elective cs for women diagnosed with accreta, and accepting participation', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\npregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, Planned and elective cs for women diagnosed with accreta, and accepting participation\n\nExclusion Criteria:\n\nwomen who don't accept participation, women who desire hysterectomy. Women who diagnosed with accrete and placenta separated easily women with concomitant pathology and requiring hysterectomy ."}, 'identificationModule': {'nctId': 'NCT05419804', 'briefTitle': 'Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis', 'organization': {'class': 'OTHER', 'fullName': 'Assiut University'}, 'officialTitle': 'Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis, a Feasibility Study', 'orgStudyIdInfo': {'id': 'TLUSCCA'}}, 'contactsLocationsModule': {'locations': [{'zip': '71511', 'city': 'Asyut', 'country': 'Egypt', 'facility': 'Assiut Medical School', 'geoPoint': {'lat': 27.18096, 'lon': 31.18368}}], 'overallOfficials': [{'name': 'Ezzat H Sayed, professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Assiut medical school'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assiut University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator', 'investigatorFullName': 'Naglaa Mohamed', 'investigatorAffiliation': 'Assiut University'}}}}