Ignite Creation Date:
2025-12-24 @ 4:07 PM
Ignite Modification Date:
2025-12-26 @ 9:00 PM
Study NCT ID:
NCT06281366
Status:
RECRUITING
Last Update Posted:
2024-03-20
First Post:
2024-02-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Diamine Oxidase and Adverse Pregnancy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}, {'id': 'C563032', 'term': 'Preterm Premature Rupture of the Membranes'}, {'id': 'D047928', 'term': 'Premature Birth'}, {'id': 'D005313', 'term': 'Fetal Death'}], 'ancestors': [{'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D007752', 'term': 'Obstetric Labor, Premature'}, {'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-18', 'studyFirstSubmitDate': '2024-02-20', 'studyFirstSubmitQcDate': '2024-02-20', 'lastUpdatePostDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diamine oxidase activity first trimester', 'timeFrame': '11-16+6 weeks of gestation', 'description': 'diamine oxidase enzime activity in maternal blood'}, {'measure': 'Diamine oxidase gene polymorphisms', 'timeFrame': '11-16+6 weeks of gestation', 'description': 'variants of the AOC1 gene: rs10156191, rs1049742, rs1049793 and rs2052129'}], 'secondaryOutcomes': [{'measure': 'Blood Diamine oxidase activity at delivery', 'timeFrame': 'At the time of delivery', 'description': 'diamine oxidase enzime activity in maternal blood'}, {'measure': 'Placental Diamine oxidase activity at delivery', 'timeFrame': 'At the time of delivery', 'description': 'diamine oxidase enzime activity in placenta'}, {'measure': 'Blood histamine levels at delivery', 'timeFrame': 'At the time of delivery', 'description': 'histamine levels in maternal blood'}, {'measure': 'Placental histamine levels at delivery', 'timeFrame': 'At the time of delivery', 'description': 'histamine levels in placenta'}, {'measure': 'Urine histamine levels at delivery', 'timeFrame': 'At the time of delivery', 'description': 'histamine levels in 24-hour maternal urine'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Preeclampsia', 'PPROM', 'preterm birth', 'Fetal death', 'Low birthweight'], 'conditions': ['Pregnancy Complications']}, 'descriptionModule': {'briefSummary': 'In normal pregnancies, blood histamine concentration remains within normal values; however, the serum histaminolytic activity is increased. Histamine is mainly produced by mast cells, platelets, basophils, neurons and enterochromatin cells, where it is stored and released when required. Reduced DAO activities have been found in high-risk pregnancies. Lower DAO activity has been associated to miscarriage, fetal demise, preeclampsia, low birthweight and preterm birth. The placenta is very rich in DAO activity and is the principal source of increased histaminolytic activity in normal pregnancies.\n\nFirst-trimester screening for preeclampsia (PE) is a routine screening which is performed in the first trimester. Women with a positive result are at a greater risk of PE but also other pregnancy complications such as stillbirth, preterm birth and low birthweight. These cases are prescribed aspirin until term. This intervention has demonstrated to significantly reduce the risk of PE and other complications. Unfortunately, aspirin does not avoid all cases with adverse outcomes, indicating that additional mechanisms may be involved in the development of such pregnancy complications, such as DAO decreased activity.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Single pregnancies between 11+0 and 16+6 weeks of gestation and high risk for preeclampsia in the first trimester screening (risk ≥1/50)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Single pregnancy\n* Maternal age ≥18\n* High risk (≥1/50) in the first-trimester screening for preeclampsia\n* Gestational age between 11+0 and 16+6 weeks of gestation\n\nExclusion Criteria:\n\n* Fetal malformation\n* Fetal death\n* Maternal digestive inflammatory disease or intolerance\n* Refusal to give informed consent'}, 'identificationModule': {'nctId': 'NCT06281366', 'briefTitle': 'Diamine Oxidase and Adverse Pregnancy Outcomes', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'Diamine Oxidase and Adverse Pregnancy Outcomes', 'orgStudyIdInfo': {'id': 'PR(AMI)470-2023'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Pregnant women with a positive first-trimester screening for preeclampsia (high risk) and no pregnancy complications (preeclampsia, fetal death, preterm birth, PPROM, low birthweight).'}, {'label': 'Cases', 'description': 'Pregnant women with a positive first-trimester screening for preeclampsia (high risk) and any of the following pregnancy complications: preeclampsia, fetal death, preterm birth, PPROM, low birthweight.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Manel Mendoza, PhD', 'role': 'CONTACT', 'email': 'manel.mendoza@vallhebron.cat', 'phone': '+34934893085'}, {'name': 'Erika Bonacina, PhD', 'role': 'CONTACT', 'email': 'erika.bonacina@vallhebron.cat', 'phone': '+34934893264'}, {'name': 'Erika Bonacina, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Manel Mendoza, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mireia Armengol, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Manel Mendoza', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'collaborators': [{'name': 'DR Healthcare', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}