Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-01 @ 12:48 PM
Study NCT ID:
NCT06426732
Status:
RECRUITING
Last Update Posted:
2024-05-23
First Post:
2024-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-18', 'studyFirstSubmitDate': '2024-05-18', 'studyFirstSubmitQcDate': '2024-05-18', 'lastUpdatePostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-05-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females', 'timeFrame': 'from pregnancy to delivery', 'description': 'The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Blood Pressure']}, 'descriptionModule': {'briefSummary': 'The incidence of gestational hypertension and preeclampsia in the assisted reproductive technology population during pregnancy was significantly higher than that in the general normal pregnancy population. The use of assisted reproductive technology in this population due to infertility is often accompanied by many hypertension-related factors. We established a prospective cohort study based on assisted reproductive technology pregnancy population and natural pregnancy population. Through continuous monitoring of blood pressure changes and other risk factors during pregnancy in the two groups, we explored the trajectory trend and inflection point of assisted reproductive technology pregnancy population blood pressure during pregnancy. Through factor analysis, the risk factors of elevated blood pressure during pregnancy can be clearly identified, so as to carry out early intervention and strengthen the control of risk factors of elevated blood pressure in assisted reproductive technology population, in order to expect benign maternal and infant outcomes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'collect sixty patients in each group', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Exposure group:\n\nMother: Seen in the obstetrics department of our hospital and meet the following conditions at the same time:\n\n1. Complete at least one cycle of IVF or ICSI, PGD or IVM treatment (including natural cycles);\n2. Clinical pregnancy was obtained after treatment. Offspring: Offspring born after in vitro fertilization-embryo transfer technique.\n\n * Non-exposed group:\n\nMother: A mother who conceived naturally. Offspring: 1) Offspring born by natural pregnancy. 2) Offspring born from natural pregnancy of exposed mothers.\n\nExclusion Criteria:\n\n* Unwilling to participate in this research;\n* Unable to participate in this study due to special reasons, such as death, immigration, loss to follow-up;\n* Hereditary diseases, mental diseases, malignant tumors, pre-pregnancy hypertension, uterine malformations and other reproductive organ malformations;\n* Pregnant women who voluntarily terminate pregnancy due to non-preeclampsia factors;'}, 'identificationModule': {'nctId': 'NCT06426732', 'briefTitle': 'The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females', 'organization': {'class': 'OTHER', 'fullName': 'The Second Hospital of Shandong University'}, 'officialTitle': 'The Trajectory of Blood Pressure During Pregnancy in Assisted Reproductive Females', 'orgStudyIdInfo': {'id': '2022-919'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Natural pregnancy group'}, {'label': 'Assisted Reproductive Technology Group'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jinan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'cui lin lin, doctor', 'role': 'CONTACT', 'email': '13188936075@163.com', 'phone': '17660082326'}, {'name': 'wang wen ting, doctor', 'role': 'CONTACT', 'phone': '13188936075'}], 'facility': 'Cui linlin', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'centralContacts': [{'name': 'Wenting Wang, M.D. Ph.D.', 'role': 'CONTACT', 'email': '13188936075@163.com', 'phone': '+86 17660082326'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Second Hospital of Shandong University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Linlin Cui', 'investigatorAffiliation': 'The Second Hospital of Shandong University'}}}}