Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-01-24 @ 8:54 PM
Study NCT ID:
NCT01995968
Status:
UNKNOWN
Last Update Posted:
2015-08-04
First Post:
2013-11-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050497', 'term': 'Stillbirth'}, {'id': 'D005317', 'term': 'Fetal Growth Retardation'}], 'ancestors': [{'id': 'D005313', 'term': 'Fetal Death'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003643', 'term': 'Death'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D005315', 'term': 'Fetal Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006130', 'term': 'Growth Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}, 'targetDuration': '1 Week', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-31', 'studyFirstSubmitDate': '2013-11-08', 'studyFirstSubmitQcDate': '2013-11-26', 'lastUpdatePostDateStruct': {'date': '2015-08-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of antenatal detection of FGR', 'timeFrame': 'baseline', 'description': 'Crude and adjusted OR of stillbirth according to antenatal detection of FGR'}], 'secondaryOutcomes': [{'measure': 'Factors associated with lack of antenatal detection of FGR in a representative sample of SGA births', 'timeFrame': 'baseline', 'description': 'Crude and adjusted OR and 95% confidence intervals'}, {'measure': 'fetal deaths of SGA newborns with and without antenatal detection of FGR', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Stillbirth', 'Fetal growth restriction', 'Small for gestational age', 'Antenatal detection', 'Prenatal Care', 'Mass Screening'], 'conditions': ['Stillbirth', 'Intrauterine Growth Retardation', 'Infant, Small for Gestational Age']}, 'referencesModule': {'references': [{'pmid': '2590650', 'type': 'BACKGROUND', 'citation': "Altman DG, Hytten FE. Intrauterine growth retardation: let's be clear about it. Br J Obstet Gynaecol. 1989 Oct;96(10):1127-32. doi: 10.1111/j.1471-0528.1989.tb03185.x. No abstract available."}, {'pmid': '11978072', 'type': 'BACKGROUND', 'citation': 'Pardi G, Marconi AM, Cetin I. Placental-fetal interrelationship in IUGR fetuses--a review. Placenta. 2002 Apr;23 Suppl A:S136-41. doi: 10.1053/plac.2002.0802.'}, {'type': 'BACKGROUND', 'citation': 'Kaufmann P SI. Placental development. In: Polin RA FW, eds, editor. Fetal and neonatal physiology. Philadelphia: WB Saunders, 1998:59-70.'}, {'pmid': '15277896', 'type': 'BACKGROUND', 'citation': 'Baschat AA. Pathophysiology of fetal growth restriction: implications for diagnosis and surveillance. Obstet Gynecol Surv. 2004 Aug;59(8):617-27. doi: 10.1097/01.ogx.0000133943.54530.76.'}, {'pmid': '7631665', 'type': 'BACKGROUND', 'citation': 'Hecher K, Snijders R, Campbell S, Nicolaides K. Fetal venous, intracardiac, and arterial blood flow measurements in intrauterine growth retardation: relationship with fetal blood gases. Am J Obstet Gynecol. 1995 Jul;173(1):10-5. doi: 10.1016/0002-9378(95)90161-2.'}, {'pmid': '11896941', 'type': 'BACKGROUND', 'citation': 'Severi FM, Bocchi C, Visentin A, Falco P, Cobellis L, Florio P, Zagonari S, Pilu G. Uterine and fetal cerebral Doppler predict the outcome of third-trimester small-for-gestational age fetuses with normal umbilical artery Doppler. Ultrasound Obstet Gynecol. 2002 Mar;19(3):225-8. doi: 10.1046/j.1469-0705.2002.00652.x.'}, {'pmid': '19426468', 'type': 'BACKGROUND', 'citation': 'Haws RA, Yakoob MY, Soomro T, Menezes EV, Darmstadt GL, Bhutta ZA. Reducing stillbirths: screening and monitoring during pregnancy and labour. BMC Pregnancy Childbirth. 2009 May 7;9 Suppl 1(Suppl 1):S5. doi: 10.1186/1471-2393-9-S1-S5.'}, {'pmid': '21501426', 'type': 'BACKGROUND', 'citation': 'Imdad A, Yakoob MY, Siddiqui S, Bhutta ZA. Screening and triage of intrauterine growth restriction (IUGR) in general population and high risk pregnancies: a systematic review with a focus on reduction of IUGR related stillbirths. BMC Public Health. 2011 Apr 13;11 Suppl 3(Suppl 3):S1. doi: 10.1186/1471-2458-11-S3-S1.'}, {'pmid': '7755042', 'type': 'BACKGROUND', 'citation': 'Alfirevic Z, Neilson JP. Doppler ultrasonography in high-risk pregnancies: systematic review with meta-analysis. Am J Obstet Gynecol. 1995 May;172(5):1379-87. doi: 10.1016/0002-9378(95)90466-2.'}, {'pmid': '10796263', 'type': 'BACKGROUND', 'citation': 'Bricker L, Neilson JP. Routine ultrasound in late pregnancy (after 24 weeks gestation). Cochrane Database Syst Rev. 2000;(2):CD001451. doi: 10.1002/14651858.CD001451.'}, {'pmid': '18843617', 'type': 'BACKGROUND', 'citation': "Bricker L, Neilson JP, Dowswell T. Routine ultrasound in late pregnancy (after 24 weeks' gestation). Cochrane Database Syst Rev. 2008 Oct 8;(4):CD001451. doi: 10.1002/14651858.CD001451.pub3."}, {'type': 'BACKGROUND', 'citation': 'Neilson JP AZ. Doppler ultrasound for fetal assessment in high risk pregnancies (Cochrane review). The Cochrane Library, Issue 1, Oxford:Update software, 2002.'}, {'pmid': '12504932', 'type': 'BACKGROUND', 'citation': 'GRIT Study Group. A randomised trial of timed delivery for the compromised preterm fetus: short term outcomes and Bayesian interpretation. BJOG. 2003 Jan;110(1):27-32. doi: 10.1046/j.1471-0528.2003.02014.x.'}, {'pmid': '15302194', 'type': 'BACKGROUND', 'citation': 'Thornton JG, Hornbuckle J, Vail A, Spiegelhalter DJ, Levene M; GRIT study group. Infant wellbeing at 2 years of age in the Growth Restriction Intervention Trial (GRIT): multicentred randomised controlled trial. Lancet. 2004 Aug 7-13;364(9433):513-20. doi: 10.1016/S0140-6736(04)16809-8.'}, {'pmid': '15358457', 'type': 'BACKGROUND', 'citation': 'Bais JM, Eskes M, Pel M, Bonsel GJ, Bleker OP. Effectiveness of detection of intrauterine growth retardation by abdominal palpation as screening test in a low risk population: an observational study. Eur J Obstet Gynecol Reprod Biol. 2004 Oct 15;116(2):164-9. doi: 10.1016/j.ejogrb.2004.01.037.'}, {'pmid': '9688242', 'type': 'BACKGROUND', 'citation': 'Jahn A, Razum O, Berle P. Routine screening for intrauterine growth retardation in Germany: low sensitivity and questionable benefit for diagnosed cases. Acta Obstet Gynecol Scand. 1998 Jul;77(6):643-8. doi: 10.1034/j.1600-0412.1998.770611.x.'}, {'pmid': '20129608', 'type': 'BACKGROUND', 'citation': 'Mattioli KP, Sanderson M, Chauhan SP. Inadequate identification of small-for-gestational-age fetuses at an urban teaching hospital. Int J Gynaecol Obstet. 2010 May;109(2):140-3. doi: 10.1016/j.ijgo.2009.11.023. Epub 2010 Feb 2.'}, {'pmid': '15717289', 'type': 'BACKGROUND', 'citation': 'Lindqvist PG, Molin J. Does antenatal identification of small-for-gestational age fetuses significantly improve their outcome? Ultrasound Obstet Gynecol. 2005 Mar;25(3):258-64. doi: 10.1002/uog.1806.'}, {'pmid': '11023165', 'type': 'BACKGROUND', 'citation': 'Ogundipe EM, Wolfe CD, Seed P, Gamsu HR. Does the antenatal detection of small-for-gestational-age babies influence their two-year outcomes? Am J Perinatol. 2000;17(2):73-81. doi: 10.1055/s-2000-9273.'}, {'pmid': '1727582', 'type': 'BACKGROUND', 'citation': 'Fretts RC, Boyd ME, Usher RH, Usher HA. The changing pattern of fetal death, 1961-1988. Obstet Gynecol. 1992 Jan;79(1):35-9.'}]}, 'descriptionModule': {'briefSummary': 'The main objective is to assess the role of antenatal detection of fetal growth restriction (FGR) on stillbirth, by a case-control study in a population-based sample of small for gestational age (SGA) livebirths and stillbirths in 3 French counties (Isère, Savoie and Haute-Savoie). SGA births will be defined as a birthweight below the 10th percentile of French customised birth weight curves.\n\nOur secondary objectives are\n\n* to identify determinants of antenatal detection of FGR among a representative sample of SGA births, with a special interest in the definition of FGR. Our hypothesis is that births who are SGA by customised birthweight curves and non-SGA by population birthweight curves, are not detected antenatally, despite the current strategy including the use of umbilical Doppler.\n* to analyse prenatal care of a subsample of SGA stillbirths with and without detection of FGR by a confidential enquiry.', 'detailedDescription': 'Stillbirths will be identified by the RHEOP (Registre des Handicaps de l\'Enfant et Observatoire Périnatal).\n\nThe RHEOP was created in 1988 in the Isère district in the Rhône-Alpes region of France. The area covered by the registry was enlarged to include two contiguous districts in 2005 (Savoie and Haute-Savoie). This registry includes all cases of childhood disability as well as all stillbirths to residents in these districts. Its objective is to monitor the trends in stillbirth and chid disability, and to identify conditions associated with these events. The three participating districts constitute a population-based sample of 30 000 births per year. The RHEOP registry uses the WHO definition of a stillbirth, i.e., "the birth of a baby with a birth weight of 500 g or 22 or more completed weeks of gestation who died before or during labor and birth". Its completeness is checked by matching its database with three data sources : results of placental examination and fetal autopsy, adjacent register of fetal anomalies, and regional reference center for prenatal diagnosis.\n\nStillbirths are identified in maternity hospitals thanks to collaborating midwifes and routinely collected data. Several specific investigators, who are trained nurses, midwives or physicians, complete a standardized form based on the medical record for each case.\n\nFor the purpose of the project, additional data will be collected allowing to describe prenatal care including ultrasound and Doppler examinations, and obstetrical management. Healthcare professionals (GP, midwife, obstetricians and gynecologists) will be solicited if data are missing in maternity medical records. SGA stillbirths in 2012 and 2013 will be included.\n\nConsecutive SGA livebirths to residents in Isère, Savoie and Haute-Savoie, will be identified by the same way. Two months (probably october and november 2013)are approximately needed to record the sample size of controls.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '42 Weeks', 'minimumAge': '24 Weeks', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'SGA births to mothers residents in 3 French districts (Isère, Savoie and Haute-Savoie)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBirths:\n\n* Stillbirths (antepartum or intrapartum fetal death) (=Cases) or livebirths (=Controls)\n* at or after 24 completed weeks of gestational age\n* singletons\n* to mothers residents in 1 of the 3 districts (Isère, Savoie, Haute-Savoie) of the RHEOP register\n* SGA: birthweight below the 10th percentile of French customised birthweight curves)\n\nExclusion Criteria:\n\n* Fetal deaths with date of death estimated being older than date of birth by at least 1 week\n* Lethal congenital anomalies'}, 'identificationModule': {'nctId': 'NCT01995968', 'acronym': 'REPERE', 'briefTitle': 'Antenatal Detection of Fetal Growth Restriction and Stillbirths Rate.', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Grenoble'}, 'officialTitle': 'Antenatal Detection of Fetal Growth Restriction : Determinants and Consequences for Stillbirths Rate.', 'orgStudyIdInfo': {'id': 'DCIC12 08'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'SGA stillbirths (Cases)', 'description': 'Stillbirths, SGA births (below the 10th percentile of French customised birthweight curves), born in 2012-13, at or after 24 completed weeks of gestational age, without lethal congenital anomalies, to mothers residents in Isère, Savoie or Haute-Savoie', 'interventionNames': ['Other: Antenatal identification of fetal growth restriction']}, {'label': 'SGA livebirths (Controls)', 'description': 'Livebirths, SGA births (below the 10th percentile of French customised birthweight curves), born in 2013, at or after 24 completed weeks of gestational age, without lethal congenital anomalies, to mothers residents in Isère, Savoie or Haute-Savoie', 'interventionNames': ['Other: Antenatal identification of fetal growth restriction']}], 'interventions': [{'name': 'Antenatal identification of fetal growth restriction', 'type': 'OTHER', 'otherNames': ['Antenatal detection', 'Antenatal recognition', 'Antenatal suspicion'], 'description': 'FGR is considered as "identified" if:\n\n* FGR was mentioned in medical charts\n* OR at least one ultrasound fetometry had indicated an estimated fetal weight or an abdominal diameter below the 10th percentile (whatever the reference curve used)\n* OR no (or insufficient) weight gain between two ultrasounds mentioned in medical charts\n* OR pathological Doppler examination of the umbilical artery (absent or reversed blood flow at the end of diastole)\n* OR utero-placental Doppler ultrasound indicated for suspicion of growth failure', 'armGroupLabels': ['SGA livebirths (Controls)', 'SGA stillbirths (Cases)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '73200', 'city': 'Albertville', 'country': 'France', 'facility': 'CH Albertville-Moutiers', 'geoPoint': {'lat': 45.67452, 'lon': 6.39061}}, {'zip': '74000', 'city': 'Annecy', 'country': 'France', 'facility': 'Clinique Générale Annecy', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '74374', 'city': 'Annecy', 'country': 'France', 'facility': 'CH Annecy', 'geoPoint': {'lat': 45.90878, 'lon': 6.12565}}, {'zip': '74100', 'city': 'Annemasse', 'country': 'France', 'facility': 'Polyclinique de Savoie Annemasse', 'geoPoint': {'lat': 46.19439, 'lon': 6.23775}}, {'zip': '74107', 'city': 'Bonneville', 'country': 'France', 'facility': 'CHI Annemasse Bonneville', 'geoPoint': {'lat': 46.0802, 'lon': 6.40726}}, {'zip': '73704', 'city': 'Bourg-Saint-Maurice', 'country': 'France', 'facility': 'CH Bourg Saint Maurice', 'geoPoint': {'lat': 45.61463, 'lon': 6.76845}}, {'zip': '38300', 'city': 'Bourgoin', 'country': 'France', 'facility': 'Centre Hospitalier Bourgoin Jallieu', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'zip': '38300', 'city': 'Bourgoin', 'country': 'France', 'facility': 'Clinique Saint Vincent de Paul Bourgoin Jallieu', 'geoPoint': {'lat': 45.59889, 'lon': 5.27236}}, {'zip': '69677', 'city': 'Bron', 'country': 'France', 'facility': 'Hopital Femme Mere Enfant', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}, {'zip': '73000', 'city': 'Chambéry', 'country': 'France', 'facility': 'CH Chambéry', 'geoPoint': {'lat': 45.56628, 'lon': 5.92079}}, {'zip': '38432', 'city': 'Échirolles', 'country': 'France', 'facility': 'Clinique des Cèdres', 'geoPoint': {'lat': 45.14603, 'lon': 5.71441}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Chu Grenoble', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '38000', 'city': 'Grenoble', 'country': 'France', 'facility': 'Clinique Mutualiste Eaux Claires', 'geoPoint': {'lat': 45.17869, 'lon': 5.71479}}, {'zip': '69317', 'city': 'Lyon', 'country': 'France', 'facility': 'Hopital Croix rousse', 'geoPoint': {'lat': 45.74906, 'lon': 4.84789}}, {'zip': '38400', 'city': 'Saint Martin D Hères', 'country': 'France', 'facility': 'Clinique Belledonne'}, {'zip': '73303', 'city': 'Saint-Jean-de-Maurienne', 'country': 'France', 'facility': 'CH Saint Jean de Maurienne', 'geoPoint': {'lat': 45.27534, 'lon': 6.35293}}, {'zip': '74164', 'city': 'Saint-Julien-en-Genevois', 'country': 'France', 'facility': 'CH Sud Léman Valserine', 'geoPoint': {'lat': 46.14434, 'lon': 6.08256}}, {'zip': '74700', 'city': 'Sallanches', 'country': 'France', 'facility': 'Hôpitaux du Mont Blanc', 'geoPoint': {'lat': 45.94423, 'lon': 6.63162}}, {'zip': '74203', 'city': 'Thonon-les-Bains', 'country': 'France', 'facility': 'Hôpitaux du Léman', 'geoPoint': {'lat': 46.37049, 'lon': 6.47985}}, {'zip': '38209', 'city': 'Vienne', 'country': 'France', 'facility': 'Centre Hospitalier Vienne', 'geoPoint': {'lat': 45.52569, 'lon': 4.87484}}, {'zip': '38506', 'city': 'Voiron', 'country': 'France', 'facility': 'Centre Hospitalier Voiron', 'geoPoint': {'lat': 45.36471, 'lon': 5.5856}}], 'overallOfficials': [{'name': 'Anne Ego, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Grenoble'}, {'name': 'Christine CANS, MD PHD', 'role': 'STUDY_CHAIR', 'affiliation': "Registre Handicaps de l'Enfant et Observatoire Périnatal"}, {'name': 'Jennifer Zeitlin, MD PHD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'INSERM U953'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Grenoble', 'class': 'OTHER'}, 'collaborators': [{'name': "Registre de Handicap de l'Enfant et Observatoire Périnatal (RHEOP) Isère, Savoie et Haute-Savoie", 'class': 'UNKNOWN'}, {'name': "UMRS 953, Epidemiological Research Unit on Perinatal and Women's and Children's Health, INSERM", 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}