Ignite Creation Date:
2025-12-24 @ 2:55 PM
Ignite Modification Date:
2026-01-04 @ 9:36 AM
Study NCT ID:
NCT03218059
Status:
UNKNOWN
Last Update Posted:
2017-07-14
First Post:
2017-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2017-07-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-07-12', 'studyFirstSubmitDate': '2017-03-12', 'studyFirstSubmitQcDate': '2017-07-12', 'lastUpdatePostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of menstruation by questionnaire', 'timeFrame': 'six months after treatment', 'description': 'Duration of menstruation'}, {'measure': 'Endocrine level by blood examination', 'timeFrame': 'six months after treatment', 'description': 'FSH in IU/L'}, {'measure': 'Volume of menstruation by questionnaire', 'timeFrame': 'six months after treatment', 'description': 'in pictorial blood loss score'}], 'secondaryOutcomes': [{'measure': 'The length of the CSD by MRI', 'timeFrame': 'six months after treatment', 'description': 'millimeter'}, {'measure': 'The depth of the CSD by MRI', 'timeFrame': 'six months after treatment', 'description': 'millimeter'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cesarean Scar Pregnancy'], 'conditions': ['Cesarean Scar Pregnancy', 'Menstruation']}, 'descriptionModule': {'briefSummary': 'Cesarean scar pregnancy (CSP)is one of the more serious complications of pregnancies that occur after a prior cesarean delivery. No clinical guidelines have been issued for the management of CSP. More than 30 treatment methods are reported to be used in managing CSP. However, which management can achieve better clinical effects remains unknown. Therefore, this prospective study is designed to compare the outcome between MTX + transvaginal surgery and UAE + D\\&C in the treatment of CSP.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nIncreased levels of serum β-hCG and ultrasonography findings. The criteria for diagnosis by ultrasonography was the presence of the following: (1) an empty uterine cavity and endocervical canal; (2) detection of the placenta and/or a gestational sac embedded in the hysterectomy scar; (3) the presence of the gestation sac with or without a fetal pole and with or without fetal cardiac activity (depending on the gestational age) in the anterior part of the uterine isthmus; and (4) a thin (1-3 mm) or absent myometrial layer between the gestational sac and the bladder. All patients had taken Magnetic Resonance Imaging (MRI) to clarify the diagnosis . Pregnancy tissues were identified by histopathology examinations of the surgical tissues.\n\nExclusion Criteria:\n\nAll enrolled patients had no contraindications for transvaginal surgery or UAE, including renal failure, active pelvic infection, clotting disorders, or known allergy to the contrast material.'}, 'identificationModule': {'nctId': 'NCT03218059', 'briefTitle': 'Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai First Maternity and Infant Hospital'}, 'officialTitle': 'Outcome After MTX & Transvaginal Surgery or UAE & Uterine Curettage in Patients With Cesarean Scar Pregnancy', 'orgStudyIdInfo': {'id': 'ShanghaiFMIH-CSP Treatment'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Methotrexate Combined With Transvaginal Surgery', 'type': 'PROCEDURE', 'otherNames': ['Uterine Artery Embolization Combined With Uterine Curettage'], 'description': 'The methods of treatment of CSP'}]}, 'contactsLocationsModule': {'locations': [{'zip': '201204', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'contacts': [{'name': 'Xipeng Wang', 'role': 'CONTACT', 'email': 'xipengwang@hotmail.com', 'phone': '0086-13817806602'}], 'facility': 'Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Xipeng Wang', 'role': 'CONTACT', 'email': 'xipengwang@hotmail.com', 'phone': '0086-13817806602'}, {'name': 'Huihui Chen', 'role': 'CONTACT', 'email': 'huihui78505@hotmail.com', 'phone': '0086-13916278505'}], 'overallOfficials': [{'name': 'Xipeng Wang', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Gynecology, Shanghai First Maternity and Infant Hospital, affiliated to Tongji University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai First Maternity and Infant Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}