Ignite Creation Date:
2025-12-24 @ 11:19 PM
Ignite Modification Date:
2026-02-23 @ 12:21 PM
Study NCT ID:
NCT02611856
Status:
UNKNOWN
Last Update Posted:
2021-07-07
First Post:
2015-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005330', 'term': 'Fetofetal Transfusion'}], 'ancestors': [{'id': 'D000751', 'term': 'Anemia, Neonatal'}, {'id': 'D000740', 'term': 'Anemia'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007232', 'term': 'Infant, Newborn, Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'sera, urine'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 179}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2007-04-03', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-07-05', 'studyFirstSubmitDate': '2015-07-02', 'studyFirstSubmitQcDate': '2015-11-19', 'lastUpdatePostDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite measure of the cardiac function', 'timeFrame': 'one day', 'description': '* measure of the arterial blood pressure\n* cardiac echography'}, {'measure': 'Composite measure of the renal function', 'timeFrame': 'one day', 'description': '* microalbuminuria\n* level of plasmatic renin, plasmatic cortisol, prorenin, aldosterone\n* renal echography'}], 'secondaryOutcomes': [{'measure': 'Composite measure of the glycoregulation', 'timeFrame': 'one day', 'description': '* provoked oral hyperglycemia\n* level of glycemia\n* level of insulinemia\n* level of glycosuria'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['twin to twin,', 'transfusion syndrome'], 'conditions': ['Twin to Twin Transfusion Syndrome']}, 'descriptionModule': {'briefSummary': 'The twin pregnancies monochorionic are specifically explained to two main types of complications: the anomalies of the embryo affecting a symmetry and in particular the median line on one hand and malformative sequences of vascular origin on the other hand. This last category of anomalies (twin-to-twin syndrome, TTTS) develops because of the presence of a division of the foeto-placentary circulation between both twins through the pooling of certain placentary cotyledons. The latter are then vascularized by an arterial and venous foot belonging to both foetuses (anastomoses arteria-venous or veinous-arterial). It results from it an imbalance moderate but very early hemodynamic which is going to return a hypovolume twin (the donor) and its plethoric co-twin (the recipient).\n\nThese anomalies in utero could not only have consequences during the fetal life, on the born weight and the later development of newborns, but also on the organization and the functioning of a whole series of physiological systems. So these anomalies of the pregnancy could have also consequences which exceed by very far from the perinatal period, by favoring the development of the atheroma, the high blood pressure, the resistance in the insulin, and many other metabolic and endocrine functions were known for their importance in human pathology.\n\nFor these reasons the investigators suggest estimating the tensional, cardiac and metabolic status of children ex-transfusers and of children ex-transfused in 2 different age classes: between 4 and 8 years then when these children will have between 12 and 16 years.\n\nThere are also some evaluation clinical and biological of the puberty (only at the age of 12-16)\n\nTo understand a possible effect of the prenatal status of these children on the endocrinology of the puberty, the measures and the following dosages will be realized:\n\n* Test in the GnRH (T0, T30, T60, T90): dosages of LH and FSH (relationship of peaks to determine the puberty evolution),\n* Dosages of the sexual steroids, the oestradiol for the girl and the testosterone for the boy,\n* Clinical examination looking for the signs of puberty\n\nThis if study leans on the big originality of the physiopathological model of TTTS in which the children present the peculiarity to have an identical genetic and postnatal status and a different prenatal environment.\n\nThe follow-up of these children should allow:\n\n* To understand better the postnatal impact anomalies on these children in the course of pregnancy\n* To anticipate and thus to improve their care in case of appearance of biological or clinical signs'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '8 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Children aged 4 years to 8 years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Child (ren) from (s) of a twin pregnancy with fetal transfusion syndrome fetal\n* Child (ren) age (s) 4 years 0 months to 6 years 12 months\n* Child (ren) fasting\n* Consent signed by the parents or legal representative\n\nExclusion Criteria:\n\n* Child (ren) not derived (s) of a twin pregnancy with fetal transfusion syndrome fetal\n* Child (ren) age (s) under 4 years 0 months or more than 6 years 12 months\n* Child (ren) nonfasting'}, 'identificationModule': {'nctId': 'NCT02611856', 'acronym': 'STT', 'briefTitle': 'Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Assistance Publique - Hôpitaux de Paris'}, 'officialTitle': "STT Study : Pediatric Follow-up of Children's From Monochorial-diamniotic Pregnancies Complicated With a Twin-to-twin Syndrome", 'orgStudyIdInfo': {'id': 'CRC05069'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'monochorial-biamniotic pregnancies'}]}, 'contactsLocationsModule': {'locations': [{'zip': '75019', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Robert Debré', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}], 'overallOfficials': [{'name': 'Laurence Bussières, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Assistance Publique - Hôpitaux de Paris'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assistance Publique - Hôpitaux de Paris', 'class': 'OTHER'}, 'collaborators': [{'name': "Société Française d'Hypentension Artérielle", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}