Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2025-12-30 @ 9:04 AM
Study NCT ID:
NCT01773135
Status:
COMPLETED
Last Update Posted:
2014-04-03
First Post:
2013-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dr.mai_elshahm@yahoo.com', 'phone': '01003922211', 'title': 'Mohamed Saied Eldein El-Safty, Lecturer of Obstetrics and Gynecology Faculty of Medicine - Ain Shams', 'phoneExt': '002', 'organization': 'Ain Shams University Maternity Hospital'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': "It's the different time of day that blood sampling was carried out, although this reflects normal clinical practice, blood samples were collected at the time of admission to hospital regardless of the time of day, rather than diurnal pattern of ACTH."}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Pregnant Women With Threatened Preterm Labor', 'description': 'pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \\> 1 and \\< 4 cm, and/or Cervical effacement ≥ 80%.\n\nthen, collection of blood sample and tocolysis adminstration will be done\n\ninvestigators obtained a blood sample from all patient to measure the serum level of ACTH.\n\nall patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.\n\nAfter delivery, investigators devide the pateints into 2 groups (full term delivery \\& preterm delivery) and investigators compare between these 2 groups by level of hormone.', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'OG000'}, {'value': '101', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Preterm Group', 'description': 'group of patients who delivered before 37 weeks of gestation'}, {'id': 'OG001', 'title': 'Full Term Group', 'description': 'group of patients who delivered after 37 weeks of gestation'}], 'classes': [{'categories': [{'measurements': [{'value': '23.4', 'groupId': 'OG000', 'lowerLimit': '19.2', 'upperLimit': '29'}, {'value': '19.3', 'groupId': 'OG001', 'lowerLimit': '16.7', 'upperLimit': '21.5'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'U statistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': '9 weeks', 'description': 'measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor', 'unitOfMeasure': 'pg/ml', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Pregnant Women With Threatened Preterm Labor', 'description': 'pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened PTL in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \\> 1 and \\< 4 cm, and/or Cervical effacement ≥ 80%.\n\nthen, collection of blood sample and tocolysis adminstration will be done\n\ninvestigators obtained a blood sample from all patient to measure the serum level of ACTH.\n\nall patients with threatened preterm labor will received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 1-2 tablets 4 times daily of slowly releasing nifedipine (epilat retard 20 mg tablet). All women will be followed up till delivery.\n\nAfter delivery, investigators devide the pateints into 2 groups (full term delivery \\& preterm delivery) and investigators compare between these 2 groups by level of hormone.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '262'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Preterm Group', 'description': 'pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.\n\ninvestigators obtained a blood sample from all patient to measure the serum level of ACTH.\n\nall patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.\n\nthis group delivered preterm (before 37 weeks of gestation)'}, {'id': 'BG001', 'title': 'Full Term Group', 'description': 'pregnant healthy female aged from 17 to 35 who suffered from symptoms of threatened preterm labor.\n\ninvestigators obtained a blood sample from all patient to measure the serum level of ACTH.\n\nall patients with threatened preterm labor received a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet). The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women followed up till delivery.\n\nthis group delivered full term (after 37 weeks of gestation)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'BG000', 'lowerLimit': '22', 'upperLimit': '29'}, {'value': '26', 'groupId': 'BG001', 'lowerLimit': '22', 'upperLimit': '30'}, {'value': '26', 'groupId': 'BG002', 'lowerLimit': '22', 'upperLimit': '30'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'INTER_QUARTILE_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '161', 'groupId': 'BG000'}, {'value': '101', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'gestational age at admission', 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'BG000', 'lowerLimit': '29', 'upperLimit': '33'}, {'value': '31', 'groupId': 'BG001', 'lowerLimit': '30', 'upperLimit': '33'}, {'value': '31', 'groupId': 'BG002', 'lowerLimit': '30', 'upperLimit': '33'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'weeks', 'dispersionType': 'INTER_QUARTILE_RANGE'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}, 'targetDuration': '9 Weeks', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-02', 'completionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-02-21', 'studyFirstSubmitDate': '2013-01-15', 'resultsFirstSubmitDate': '2014-02-21', 'studyFirstSubmitQcDate': '2013-01-18', 'lastUpdatePostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-02-21', 'studyFirstPostDateStruct': {'date': '2013-01-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate if ACTH Can be Used as a Predictive Marker for Preterm Labor', 'timeFrame': '9 weeks', 'description': 'measurement of maternal serum ACTH in women daignosed as threatened preterm labor to evaluate if this hormone can be used as a predictive marker for preterm labor'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['threatened preterm labor', 'ACTH', 'PTL'], 'conditions': ['Threatened Preterm Labor']}, 'descriptionModule': {'briefSummary': 'The aim of this study is use of ACTH as a predictive marker in patients of threatened preterm labor .', 'detailedDescription': 'This is a cross sectional study that will include 261 pregnant women aged between 17 and 35 years with singleton pregnancies between 28 and 36 completed weeks of gestation that had been diagnosed with threatened preterm labor and consented to participate in this study. This study will be conducted at Ain Shams University Maternity Hospital after approval of the research and ethics committee.\n\nthe investigators include all patients which have these following criteria (Singleton pregnancy, Age between 17 - 35 years, Gestational age between 28 and 36 weeks and Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \\> 1 and \\< 4 cm, and/or Cervical effacement ≥ 80%.\n\nthe investigators exclude any patient which has any of the following criteria (Preterm rupture of membranes, Any uterine anomalies or cervical incompetence, Chronic illness such as chronic hypertension or kidney disease, Diabetes mellitus, Abruptio placenta, Preeclampsia and HELLP syndrome, Fetal anomalies, IUGR, Smoking or Clinical signs of intrauterine infection).\n\nblood sample was collected from each patient for measurement of ACTH level. According to local protocol in Ain Shams University Maternity Hospital all women will receive a fixed regimen of tocolysis in the form of nifedipine (Epilat) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women will be followed up till delivery.\n\nAfter delivery, the investigators divide the patients into 2 groups (full term delivery \\& preterm delivery) and we compare between these 2 groups by level of hormone.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '17 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'pregnant women aged between 17 and 35 years with singleton pregnancies between 28 and 36 completed weeks of gestation that had been diagnosed with threatened preterm labor', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Singleton pregnancy.\n* Age between 17 - 35 years.\n* Gestational age between 28 and 36 weeks.\n* Diagnosis of threatened preterm labor is based on the American College of Obstetricians and Gynaecologists Guidelines (ACOG, 2003): Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \\> 1 and \\< 4 cm, and/or Cervical effacement ≥ 80%.\n\nExclusion Criteria:\n\n* Preterm rupture of membranes.\n* Any uterine anomalies or cervical incompetence.\n* Chronic illness such as chronic hypertension or kidney disease.\n* Diabetes mellitus.\n* Abruptio placenta.\n* Preeclampsia and HELLP syndrome.\n* Fetal anomalies.\n* IUGR.\n* Smoking.\n* Clinical signs of intrauterine infection eg (uterine tenderness, foul vaginal discharge, maternal pyrexia ≥ 38°C and/or maternal leucocytosis).'}, 'identificationModule': {'nctId': 'NCT01773135', 'acronym': 'PTL', 'briefTitle': 'Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Maternal Serum Level of ACTH as a Predictive Marker of Preterm Labor in Patients With Threatened Preterm Labor', 'orgStudyIdInfo': {'id': 'mai-01110333535'}, 'secondaryIdInfos': [{'id': 'MAI-01110333535m', 'type': 'REGISTRY', 'domain': 'mai ibrahim ali ibrahim'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'preterm group', 'description': 'pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened preterm labor in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \\> 1 and \\< 4 cm, and/or Cervical effacement ≥ 80%. collection of blood sample and tocolysis administration will be done this group will deliver preterm (before 37 weeks of gestation)', 'interventionNames': ['Other: collection of blood sample and tocolysis adminstration']}, {'label': 'full term group', 'description': 'pregnant healthy women aged from 17 to 35 who suffered from symptoms of threatened preterm labor in the form of Presence of uterine contractions (at least 4 in 20 minutes or 8 in 60 minutes), Cervical dilation \\> 1 and \\< 4 cm, and/or Cervical effacement ≥ 80%. collection of blood sample and tocolysis administration will be done this group will deliver full term (after 37 weeks of gestation)', 'interventionNames': ['Other: collection of blood sample and tocolysis adminstration']}], 'interventions': [{'name': 'collection of blood sample and tocolysis adminstration', 'type': 'OTHER', 'description': 'investigators will abtain a blood sample from all patient to measure the serum level of ACTH.\n\nall patients with threatened preterm labor will receive a fixed regimen of tocolysis in the form of nifedipine (Epilate) 10 mg orally every 15 minutes for the first hour or until cessation of uterine contractions. Then, 60 - 160 mg/day (1-2 tablets 3 times daily) of slowly releasing nifedipine (epilat retard 20 mg tablet) may be given depending on uterine activity. The patients will also receive 6 mg dexamethasone every 12 hours for 4 doses. All women will be followed up till delivery.\n\nAfter delivery, investigators devide the pateints into 2 groups (full term delivery \\& preterm delivery) and investigators compare between these 2 groups by level of hormone.', 'armGroupLabels': ['full term group', 'preterm group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '133119', 'city': 'Cairo', 'state': 'Egypt', 'country': 'Egypt', 'facility': 'Ainshams Maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Mohamed S. Elsafty, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ain Shams University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lecturer of Obstetrics and Gynecology Faculty of Medicine - Ain Shams University', 'investigatorFullName': 'Mohamed Saied Eldein El-Safty', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}