Ignite Creation Date:
2025-12-24 @ 7:41 PM
Ignite Modification Date:
2026-02-09 @ 5:54 AM
Study NCT ID:
NCT02739503
Status:
UNKNOWN
Last Update Posted:
2017-01-10
First Post:
2016-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fetal Head Circumference as a Predictor of Operative Delivery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D014463', 'term': 'Ultrasonography'}], 'ancestors': [{'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-06', 'studyFirstSubmitDate': '2016-04-07', 'studyFirstSubmitQcDate': '2016-04-14', 'lastUpdatePostDateStruct': {'date': '2017-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of "operative delivery" including instrumental deliveries or cesarean sections.', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Length (in hours) of the first and second stages of labor.', 'timeFrame': '1 year'}, {'measure': 'Rate of obstetric anal sphincter injury.', 'timeFrame': '1 year'}, {'measure': 'Rate of early postpartum hemorrhage (PPH).', 'timeFrame': '1 year'}, {'measure': 'Rate of neonatal trauma.', 'timeFrame': '1 year'}, {'measure': 'Rate of admission to the neonatal intensive care unit.', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Pregnancy']}, 'referencesModule': {'references': [{'pmid': '26488523', 'type': 'BACKGROUND', 'citation': 'ACOG Practice Bulletin No. 154: Operative Vaginal Delivery. Obstet Gynecol. 2015 Nov;126(5):e56-e65. doi: 10.1097/AOG.0000000000001147. No abstract available.'}, {'pmid': '11675055', 'type': 'BACKGROUND', 'citation': 'Murphy DJ, Liebling RE, Verity L, Swingler R, Patel R. Early maternal and neonatal morbidity associated with operative delivery in second stage of labour: a cohort study. Lancet. 2001 Oct 13;358(9289):1203-7. doi: 10.1016/S0140-6736(01)06341-3.'}, {'pmid': '20633305', 'type': 'BACKGROUND', 'citation': 'Maharaj D. Assessing cephalopelvic disproportion: back to the basics. Obstet Gynecol Surv. 2010 Jun;65(6):387-95. doi: 10.1097/OGX.0b013e3181ecdf0c.'}, {'pmid': '19443160', 'type': 'BACKGROUND', 'citation': 'Lenhard MS, Johnson TR, Weckbach S, Nikolaou K, Friese K, Hasbargen U. Pelvimetry revisited: analyzing cephalopelvic disproportion. Eur J Radiol. 2010 Jun;74(3):e107-11. doi: 10.1016/j.ejrad.2009.04.042. Epub 2009 May 13.'}, {'pmid': '17290365', 'type': 'BACKGROUND', 'citation': "Peregrine E, O'Brien P, Jauniaux E. Clinical and ultrasound estimation of birth weight prior to induction of labor at term. Ultrasound Obstet Gynecol. 2007 Mar;29(3):304-9. doi: 10.1002/uog.3949."}, {'pmid': '10796221', 'type': 'BACKGROUND', 'citation': 'Irion O, Boulvain M. Induction of labour for suspected fetal macrosomia. Cochrane Database Syst Rev. 2000;(2):CD000938. doi: 10.1002/14651858.CD000938.'}, {'pmid': '22229662', 'type': 'BACKGROUND', 'citation': 'Elvander C, Hogberg U, Ekeus C. The influence of fetal head circumference on labor outcome: a population-based register study. Acta Obstet Gynecol Scand. 2012 Apr;91(4):470-5. doi: 10.1111/j.1600-0412.2012.01358.x. Epub 2012 Feb 28.'}, {'pmid': '23651454', 'type': 'BACKGROUND', 'citation': 'Mujugira A, Osoti A, Deya R, Hawes SE, Phipps AI. Fetal head circumference, operative delivery, and fetal outcomes: a multi-ethnic population-based cohort study. BMC Pregnancy Childbirth. 2013 May 7;13:106. doi: 10.1186/1471-2393-13-106.'}, {'pmid': '18348183', 'type': 'BACKGROUND', 'citation': 'Verburg BO, Steegers EA, De Ridder M, Snijders RJ, Smith E, Hofman A, Moll HA, Jaddoe VW, Witteman JC. New charts for ultrasound dating of pregnancy and assessment of fetal growth: longitudinal data from a population-based cohort study. Ultrasound Obstet Gynecol. 2008 Apr;31(4):388-96. doi: 10.1002/uog.5225.'}]}, 'descriptionModule': {'briefSummary': 'This study set out to investigate whether antenatal ultrasound evaluation of the Fetal Head Circumference (FHC) could potentially possess a predictive role in determining women at increased risk for operative delivery or cesarean section.', 'detailedDescription': 'When vaginal delivery poses a danger to the mother or newborn infant, operative delivery (instrumental or cesarean section) is indicated. Some specific indications for operative delivery include prolonged second-stage of labor, suspected compromise of the fetus, health-related disorders of the fetus or the mother that justify shortening of the second-stage of active labor and more. In cases where cephalo-pelvic disproportion (CPD) is suspected or when instrumental delivery is not possible or fails, cesarean section plays a critical role . Studies trying to identify women at greatest risk of CPD have concluded that neither x ray, nor computed tomography or magnetic resonance imaging have a proven value in labor management or in predicting clinical outcomes . Previous studies assessing fetal factors that are associated with operative delivery have focused mainly on estimated fetal weight to predict macrosomia. Nonetheless, ultrasound estimation of the fetal weight was shown to differ by as much as 20% from actual birth weight, and identifying cases with suspected fetal macrosomia, other than for diabetic pregnancies, was not found to improve labor outcome . As weeks may possibly elapse between the time of last antenatal assessment and onset of labor, a further challenge is related to the timing of ultrasound assessment. Several studies have shown an association between increased Fetal Head Circumference (FHC) and prolonged second-stage of labor, instrumental delivery and cesarean section . However, FHC can only be acquired following delivery and has no predictive value for interventions in labor.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': "Women at term (37+0 - 42+0 weeks' gestation)", 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Women at term (37+0 - 42+0 weeks' gestation)\n2. Singleton pregnancies\n3. Cephalic presentation\n4. Anticipated vaginal delivery\n\nExclusion Criteria:\n\n1. Younger than 18 years old and older than 45 years old\n2. Women who incapable of providing informed consent"}, 'identificationModule': {'nctId': 'NCT02739503', 'briefTitle': 'Fetal Head Circumference as a Predictor of Operative Delivery', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Hillel Yaffe Medical Center'}, 'officialTitle': 'Fetal Head Circumference as a Predictor of Operative Delivery', 'orgStudyIdInfo': {'id': '0017-16-HYMC'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Ultrasound', 'type': 'DEVICE', 'description': 'Patients will receive ultrasound in the ultrasound unit at Hillel Yaffe Medical Center within 10 days before onset of induced or spontaneous labors. The ultrasound team has been trained in FHC , Estimated Fetal Weight (EFW) and Biparietal Diameter (BPD) measurement .Optimal ultrasound measurements of FHC and BPD will be obtained. The average of 3 fetal head circumference measurements will be recorded. Investigators consider the FHC and BPD to be optimal when a clear outline of the entire fetal skull is measured, and the landmarks (the thalamus, cavum septum pellucidum and choroid plexus in the atrium of the lateral ventricles) are visualized. Subsequent information of labor outcome as well as normal head circumference ,post-delivery will be obtained from maternal and neonatal medical records.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '38100', 'city': 'Hadera', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ofer Limonad, M.D', 'role': 'CONTACT', 'email': 'oferlimonad@gmail.com', 'phone': '00-972-52-5322972'}, {'name': 'Ofer Limonad, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Alon Scrim, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center', 'geoPoint': {'lat': 32.44192, 'lon': 34.9039}}], 'centralContacts': [{'name': 'Ofer Limonad, M.D', 'role': 'CONTACT', 'email': 'oferlimonad@gmail.com'}, {'name': 'Alon Shrim, M.D', 'role': 'CONTACT', 'email': 'alon.shrim@gmail.com'}], 'overallOfficials': [{'name': 'Ofer Limonad, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hillel Yaffe Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hillel Yaffe Medical Center', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}