Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2025-12-25 @ 1:53 PM
Study NCT ID:
NCT04205292
Status:
UNKNOWN
Last Update Posted:
2020-10-08
First Post:
2019-12-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002921', 'term': 'Cicatrix'}], 'ancestors': [{'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015907', 'term': 'Hysteroscopy'}], 'ancestors': [{'id': 'D003944', 'term': 'Diagnostic Techniques, Obstetrical and Gynecological'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D004724', 'term': 'Endoscopy'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D013513', 'term': 'Obstetric Surgical Procedures'}, {'id': 'D013509', 'term': 'Gynecologic Surgical Procedures'}, {'id': 'D013519', 'term': 'Urogenital Surgical Procedures'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-12-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-10', 'completionDateStruct': {'date': '2022-01-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-10-07', 'studyFirstSubmitDate': '2019-12-15', 'studyFirstSubmitQcDate': '2019-12-17', 'lastUpdatePostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'success rate of treatment protocols,', 'timeFrame': 'resolution of scar pregnancy, day 7', 'description': 'defined as no further treatment required until the complete resolution of the scar pregnancy.'}], 'secondaryOutcomes': [{'measure': 'Further treatment required until the complete resolution of the scar pregnancy', 'timeFrame': 'resolution of scar pregnancy, day 7', 'description': 'Further treatment required until the complete resolution of the CSP (repeat administration of methotrexate (MTX) and/or other surgical procedures),'}, {'measure': 'histerectomy', 'timeFrame': 'resolution of scar pregnancy, day 7', 'description': 'histerectomy'}, {'measure': 'Maternal transfusion', 'timeFrame': 'resolution of scar pregnancy, day 7', 'description': 'Maternal transfusion'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Scar; Previous Cesarean Section']}, 'referencesModule': {'references': [{'pmid': '37142075', 'type': 'DERIVED', 'citation': 'Di Spiezio Sardo A, Zizolfi B, Saccone G, Ferrara C, Sglavo G, De Angelis MC, Mastantuoni E, Bifulco G. Hysteroscopic resection vs ultrasound-guided dilation and evacuation for treatment of cesarean scar ectopic pregnancy: a randomized clinical trial. Am J Obstet Gynecol. 2023 Oct;229(4):437.e1-437.e7. doi: 10.1016/j.ajog.2023.04.038. Epub 2023 May 3.'}]}, 'descriptionModule': {'briefSummary': 'Cesarean scar pregnancy (CSP) is a relative "new" type of ectopic pregnancy where the fertilized egg is implanted in the muscle or fibrous tissue of the scar after a previous cesarean section.\n\nA recent review amounts almost 31 different treatment modalities for CSP. A broad spectrum of options represents a real challenge for the health care provider. The choice may be made among expectant management, medical treatment, local treatment and surgical approach, also combined together. There is insufficient evidence to recommend any one specific intervention over another for caesarean scar pregnancy. Future studies are needed to define the optimal management of pregnancy for caesarean section scars.\n\nThus, we aim to compare the success rate of two different treatment of CSP: the medical management by using two-dose of Methotrexate (MTX) followed by dilation and evacuation (D\\&E) compared to single dose of two-dose of Methotrexate followed by hysperoscopic approach.', 'detailedDescription': 'Cesarean scar pregnancy (CSP) is a relative "new" type of ectopic pregnancy where the fertilized egg is implanted in the muscle or fibrous tissue of the scar after a previous cesarean section. Since the first description of cesarean scar pregnancy in 1978, its frequency has increased dramatically due to the significant increase in the percentage of cesarean section and development of transvaginal (TV) ultrasonography (US). The overall incidence of CSP is 1 in 1,800 to 1 in 2,200 pregnancies, it means 0.05-0.04% of all pregnancies. In women after a cesarean section, the frequency of CSP is approximately 0.15%, which constitutes 6.1% of all ectopic pregnancies in patients after at least one cesarean operation. The risk factors that favour implantation in the CS scar are not well understood; therefore, there are no guidelines for the practicing physicians to determine the women at risk. Uterine surgery, anomalous healing of the scar, previous preterm CS without labour or a term elective CS, breech presentation at previous CS short intervals between the CSP and last pregnancy, last pregnancy ended with abortion may be some of the risk factors for CSP.\n\nAlthough the 15% of CSPs remain undiagnosed, developed egographic techniques and several new US signs of CSP invasiveness are allowing ever better diagnoses. Cali et al. tested the hypothesis the relationship between the gestational sac of the CSP, previous caesarean scar and the anterior uterine wall can be used to predict the evolution of these cases. In order to do this, they propose a new sonographic sign, the "cross-over sign" (COS) . This echographic sign is reflected in the clinical presentation of the CSP, so we can divide the patients into two different groups: type I "endogenic type" characterized by the COS2 insertion, ance type II "exogenic type" characterized by COS1 insertion, the latter with worse outcomes in term of maternal morbidity and mortality.\n\nA recent review amounts almost 31 different treatment modalities for CSP. A broad spectrum of options represents a real challenge for the health care provider. The choice may be made among expectant management, medical treatment, local treatment and surgical approach, also combined together. There is insufficient evidence to recommend any one specific intervention over another for caesarean scar pregnancy. Future studies are needed to define the optimal management of pregnancy for caesarean section scars.\n\nThus, we aim to compare the success rate of two different treatment of CSP: the medical management by using two-dose of Methotrexate (MTX) followed by dilation and evacuation (D\\&E) compared to single dose of two-dose of Methotrexate followed by hysperoscopic approach.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton gestations;\n* 18 years to 50 years;\n* Diagnosis of CSP;\n* Gestational age ≤ 8 weeks and 6 days;\n* Therapy with systemic Methotrexate 2-dose;\n* Thickness of myometrial layer ≥2 mm.\n\nExclusion Criteria:\n\n* Diagnosis of cervical pregnancy, aborting intrauterine pregnancy, or any other anomalous implantation site;\n* Gestational age \\>8 weeks and 6 days;\n* Heavy vaginal bleeding at the time of randomization;\n* Women who did not received Methotrexate or received a single dose or a local dose;\n* Thickness of myometrial layer \\<2 mm\n* Women who are unconscious, ill, mentally handicapped;\n* Women under the age of 18 years or over the age of 50 years.'}, 'identificationModule': {'nctId': 'NCT04205292', 'briefTitle': 'Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Federico II University'}, 'officialTitle': 'Cesarean Scar Pregnancy Managed by Dilatation and Evacuation (D&E) Versus Hysteroscopic Surgery', 'orgStudyIdInfo': {'id': '298-19'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Dilatation and Evacuation (D&E)', 'description': 'Women in this group will receive an in-patient treatment with Dilatation and Evacuation (D\\&E) after two doses of Methotrexate .', 'interventionNames': ['Procedure: hysteroscopic']}, {'type': 'EXPERIMENTAL', 'label': 'hysteroscopic surgery', 'description': 'Women in this group will receive hysteroscopic surgery after two doses of Methotrexate .', 'interventionNames': ['Procedure: hysteroscopic']}], 'interventions': [{'name': 'hysteroscopic', 'type': 'PROCEDURE', 'description': 'Women in the intervention group will receive an inpatient treatment with two-dose of Methotrexate followed by hysteroscopic resection under ultrasound guidance', 'armGroupLabels': ['Dilatation and Evacuation (D&E)', 'hysteroscopic surgery']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80129', 'city': 'Napoli', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gabriele Saccone', 'role': 'CONTACT', 'email': 'gabriele.saccone@libero.it', 'phone': '3394685179'}], 'facility': 'Gabriele Saccone', 'geoPoint': {'lat': 40.87618, 'lon': 14.5195}}], 'centralContacts': [{'name': 'Gabriele Saccone, MD', 'role': 'CONTACT', 'email': 'gabriele.saccone@unina.it', 'phone': '0817461111'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'no plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federico II University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Gabriele Saccone', 'investigatorAffiliation': 'Federico II University'}}}}