Ignite Creation Date:
2025-12-24 @ 10:51 PM
Ignite Modification Date:
2025-12-25 @ 8:20 PM
Study NCT ID:
NCT05484869
Status:
COMPLETED
Last Update Posted:
2022-09-01
First Post:
2022-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 297}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-27', 'studyFirstSubmitDate': '2022-07-22', 'studyFirstSubmitQcDate': '2022-07-30', 'lastUpdatePostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delivery type in pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'The % of delivery type (vaginal delivery/ cesarean section) will be compared between the three groups'}, {'measure': 'Abortion ratio of pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of abortion will be compared between the three groups'}, {'measure': 'Neonatal death ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of neonatal death will be compared between the three groups'}, {'measure': 'Premature rupture of membranes in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of premature rupture of membranes (PROM) will be compared between the three groups'}, {'measure': 'Preterm labor ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of preterm labor will be compared between the three groups'}, {'measure': 'Ablatio placentae ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of ablatio placentae will be compared between the three groups'}, {'measure': 'Fetal Distress ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of fetal distress will be compared between the three groups'}, {'measure': 'Intrauterine death ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of intrauterine death will be compared between the three groups'}, {'measure': 'Gestational diabetes ratio in pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of gestational diabetes mellitus (GDM) will be compared between the three groups'}, {'measure': 'Preeclampsia ratio in pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of preeclampsia will be compared between the three groups'}, {'measure': 'Surmaturation ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of surmaturation will be compared between the three groups'}, {'measure': 'Polyhydramnios ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of polyhydramnios will be compared between the three groups'}, {'measure': 'Oligohydramnios ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of oligohydramnios will be compared between the three groups'}, {'measure': 'Presentation anomaly ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of presentation anomaly will be compared between the three groups'}, {'measure': 'Multiple pregnancy ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of multiple pregnancy will be compared between the three groups'}, {'measure': 'Intrauterine growth retardation ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of intrauterine growth retardation (IUGR) will be compared between the three groups'}, {'measure': 'Postpartum hemorrhage ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of postpartum hemorrhage will be compared between the three groups'}, {'measure': 'Placenta previa ratio in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'Rate and % of placenta previa will be compared between the three groups'}, {'measure': 'Mean fetal weight of pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1month', 'description': 'The fetal weight (in grams) will be compared between the three groups'}, {'measure': 'Ratio of male, female gender in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': '% of male, female gender will be compared between the three groups'}, {'measure': 'Mean APGAR scores in the 1st minute in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'APGAR scores in the 1st minute (by numbers) will be compared between the three groups'}, {'measure': 'Mean APGAR scores in the 5th minute in pregnancies of pregnant women under the age of 16 ( group 1), over the age of 45 (group 2) and between the age of 25-35 (group 3).', 'timeFrame': '1 month', 'description': 'APGAR scores in the 5th minute (by numbers) will be compared between the three groups'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['age', 'pregnancy', 'adolescent', 'perinatal', 'neonatal'], 'conditions': ['Advanced Maternal Age Pregnancy', 'Early Pregnancy']}, 'referencesModule': {'references': [{'pmid': '26169538', 'type': 'BACKGROUND', 'citation': 'Brown W, Ahmed S, Roche N, Sonneveldt E, Darmstadt GL. Impact of family planning programs in reducing high-risk births due to younger and older maternal age, short birth intervals, and high parity. Semin Perinatol. 2015 Aug;39(5):338-44. doi: 10.1053/j.semperi.2015.06.006. Epub 2015 Jul 10.'}, {'pmid': '22088316', 'type': 'BACKGROUND', 'citation': 'Malabarey OT, Balayla J, Klam SL, Shrim A, Abenhaim HA. Pregnancies in young adolescent mothers: a population-based study on 37 million births. J Pediatr Adolesc Gynecol. 2012 Apr;25(2):98-102. doi: 10.1016/j.jpag.2011.09.004. Epub 2011 Nov 16.'}, {'pmid': '25842790', 'type': 'BACKGROUND', 'citation': 'Traisrisilp K, Tongsong T. Pregnancy outcomes of mothers with very advanced maternal age (40 years or more). J Med Assoc Thai. 2015 Feb;98(2):117-22.'}]}, 'descriptionModule': {'briefSummary': "Maternal age is an important factor affecting the pregnancy process and its results. Adverse obstetric outcomes such as preterm birth, stillbirth, and infant mortality are more common in women older than 35 years and younger than 20 years compared to women aged 20-29. Adolescent pregnancies have been associated with an increased risk of adverse pregnancy outcomes such as preterm birth, low birth weight, perinatal death, and maternal mortality.\n\nAdvanced maternal age pregnancies were associated with higher rates of maternal hypertension and diabetes, and progressively worsening perinatal outcomes such as stillbirth, preterm birth, and low birth weight.\n\nAlthough the investigators' region has high birth rates, as far as they have observed, the rates of early and advanced maternal age are also quite high. the investigators' aim in this study is to determine the absolute effects of early and advanced maternal age on pregnancy and to investigate the pregnancy outcomes of these mothers.", 'detailedDescription': "The investigators' aim in this study is to determine the absolute effects of early and advanced maternal age on pregnancy and to investigate the pregnancy outcomes of these mothers. For this purpose, the information of 90 pregnant women followed in Siirt Training and Research Hospital between 2017-2021 will be accessed through the hospital's data system. Maternal age, pregnancy history, Assisted reproductive technologies history, laboratory findings, screening test results, mode of delivery, baby birth information, pregnancy complications and complications during delivery will be recorded. In the light of the information gathered, the rates of negative effects of gestational age on pregnancy will be calculated."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '47 Years', 'minimumAge': '15 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Pregnant on the age of 16 and below and on the age of 45 and above, control groups', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnants under the age of 16 and younger\n* pregnants over the age of 45 and older\n\nExclusion Criteria:\n\n* history of chronic hypertension\n* history of pre gestational diabetes\n* history of chronic diseases\n* excessive consumption of alcohol\n* smoking pregnants\n* kidney disorders'}, 'identificationModule': {'nctId': 'NCT05484869', 'briefTitle': 'Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Siirt University'}, 'officialTitle': 'Comparison of Perinatal and Neonatal Outcomes of Very Advanced Maternal Aged Pregnants and Early Adolescent Pregnant Women', 'orgStudyIdInfo': {'id': 'SiirtUNIVER'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Early Adolescent Pregnant Women (n:80)', 'description': 'Perinatal and neonatal results of adolescent pregnancies of 16 years and below'}, {'label': 'Very Advanced Maternal Aged Pregnants (n:67)', 'description': 'Perinatal and neonatal results of pregnancies 45 years and older'}, {'label': 'Reproductive period Control Group (n:150)', 'description': 'Reproductive period Pregnant Between 25-35 years'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Şerif Aksin, Assoc.Prof', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Siirt University Medical Faculty Obstetrics and Gynecology Departmant'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siirt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'Serif Aksin', 'investigatorAffiliation': 'Siirt University'}}}}