Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-31 @ 7:04 AM
Study NCT ID:
NCT04827433
Status:
RECRUITING
Last Update Posted:
2024-01-02
First Post:
2021-03-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mode of Delivery in Women With Low-lying Placenta
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006470', 'term': 'Hemorrhage'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2550}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-10-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-04-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-29', 'studyFirstSubmitDate': '2021-03-22', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2024-01-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-28', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of vaginal delivery and urgent cesarean section', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Rate of vaginal birth and emergency cesarean section in labor due to vaginal bleeding'}], 'secondaryOutcomes': [{'measure': 'Frequency of resolution of placenta previa or low-lying', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Frequency of resolution of placenta previa or low-lying in relation to the placental location at the time of diagnosis and in relation to maternal history of hysterotomy'}, {'measure': 'Placental migration speed and its correlation with different variables', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Description of time needed for resolution of previa or low-lying placenta in relation to placental location at diagnosis (anterior/posterior; praevia/low-lying), and maternal history of hysterotomy, and its correlation to the mode of birth and risk of bleeding during pregnancy and in labor.'}, {'measure': 'Frequency of ultrasound visualization of the marginal breast in low-lying placentas and other variables', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Frequency of marginal sinus in women with low-lying placenta and its relation with mode of birth and risk of ante-, intra-, and post-partum bleeding.'}, {'measure': 'Refusal of elective caesarean section', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Rate of women declining the mode of birth suggested by clinicians during counselling.'}, {'measure': 'Morbidity associated with the various groups of placental distance analyzed by the antepartum hemorrhage incidence.', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Incidence of antepartum hemorrhage requiring hospital admission or immediate delivery.'}, {'measure': 'Morbidity associated with the various groups of placental distance studied with the intrapartum hemorrhage incidence.', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Incidence of intrapartum hemorrhage requiring emergency CS.'}, {'measure': 'Morbidity associated with the various groups of placental distance through the severe postpartum hemorrhage incidence.', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Incidence of severe postpartum hemorrhage, defined as bleeding ≥ 1000 ml following birth and administration of uterotonic drugs, use of balloon tamponade, uterine artery embolization, ligature of uterine arteries, hysterectomy, blood transfusion;'}, {'measure': 'Morbidity associated with the various groups of placental distance associated with the admission to Intensive Care Unit (ICU)', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'The maternal admission to ICU.'}, {'measure': 'Morbidity associated with the various groups of placental distance described by the preterm bith incidence', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Incidence of preterm birth can described the morbidity associated wiith the various groups of placenta distance.'}, {'measure': 'Morbidity associated with the various groups of placental distance described through the preterm incidence less than 32 weeks.', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Incidence of preterm birth \\< 32 weeks.'}, {'measure': 'Morbidity associated with the various groups of placental distance according to the neonatal admission to ICU', 'timeFrame': 'Until the end of the study (approximately 54 months).', 'description': 'Neonatal admission to Neonatal ICU and length of stay.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['low-lying placenta', 'mode of birth', 'labor and birth'], 'conditions': ['Low-Lying; Placenta, Hemorrhage, Complicating Delivery']}, 'referencesModule': {'references': [{'pmid': '28742678', 'type': 'BACKGROUND', 'citation': 'Committee on Obstetric Practice. Committee Opinion No. 713: Antenatal Corticosteroid Therapy for Fetal Maturation. Obstet Gynecol. 2017 Aug;130(2):e102-e109. doi: 10.1097/AOG.0000000000002237.'}, {'pmid': '30681545', 'type': 'BACKGROUND', 'citation': 'ACOG Committee Opinion No. 764: Medically Indicated Late-Preterm and Early-Term Deliveries. Obstet Gynecol. 2019 Feb;133(2):e151-e155. doi: 10.1097/AOG.0000000000003083.'}, {'pmid': '25222161', 'type': 'BACKGROUND', 'citation': 'Al Wadi K, Schneider C, Burym C, Reid G, Hunt J, Menticoglou S. Evaluating the safety of labour in women with a placental edge 11 to 20 mm from the internal cervical Os. J Obstet Gynaecol Can. 2014 Aug;36(8):674-677. doi: 10.1016/S1701-2163(15)30508-9.'}, {'pmid': '21962622', 'type': 'BACKGROUND', 'citation': 'Blackwell SC. Timing of delivery for women with stable placenta previa. Semin Perinatol. 2011 Oct;35(5):249-51. doi: 10.1053/j.semperi.2011.05.004.'}, {'pmid': '14511970', 'type': 'BACKGROUND', 'citation': 'Bhide A, Prefumo F, Moore J, Hollis B, Thilaganathan B. Placental edge to internal os distance in the late third trimester and mode of delivery in placenta praevia. BJOG. 2003 Sep;110(9):860-4.'}, {'pmid': '30688129', 'type': 'BACKGROUND', 'citation': 'Alouini S, Megier P, Fauconnier A, Huchon C, Fievet A, Ramos A, Megier C, Valery A. Diagnosis and management of placenta previa and low placental implantation. J Matern Fetal Neonatal Med. 2020 Oct;33(19):3221-3226. doi: 10.1080/14767058.2019.1570118. Epub 2019 Jan 27.'}, {'pmid': '24176163', 'type': 'BACKGROUND', 'citation': 'Dashe JS. Toward consistent terminology of placental location. Semin Perinatol. 2013 Oct;37(5):375-9. doi: 10.1053/j.semperi.2013.06.017.'}, {'pmid': '3048096', 'type': 'BACKGROUND', 'citation': 'Farine D, Fox HE, Jakobson S, Timor-Tritsch IE. Vaginal ultrasound for diagnosis of placenta previa. Am J Obstet Gynecol. 1988 Sep;159(3):566-9. doi: 10.1016/s0002-9378(88)80009-7.'}, {'pmid': '19173234', 'type': 'BACKGROUND', 'citation': 'Bronsteen R, Valice R, Lee W, Blackwell S, Balasubramaniam M, Comstock C. Effect of a low-lying placenta on delivery outcome. Ultrasound Obstet Gynecol. 2009 Feb;33(2):204-8. doi: 10.1002/uog.6304.'}, {'pmid': '23505018', 'type': 'BACKGROUND', 'citation': 'Ginsberg Y, Goldstein I, Lowenstein L, Weiner Z. Measurements of the lower uterine segment during gestation. J Clin Ultrasound. 2013 May;41(4):214-7. doi: 10.1002/jcu.22023. Epub 2013 Mar 16.'}, {'pmid': '27032737', 'type': 'BACKGROUND', 'citation': 'Fukuda M, Fukuda K, Shimizu T, Bujold E. Ultrasound Assessment of Lower Uterine Segment Thickness During Pregnancy, Labour, and the Postpartum Period. J Obstet Gynaecol Can. 2016 Feb;38(2):134-40. doi: 10.1016/j.jogc.2015.12.009. Epub 2016 Mar 2.'}, {'pmid': '30663270', 'type': 'BACKGROUND', 'citation': 'Jansen C, de Mooij YM, Blomaard CM, Derks JB, van Leeuwen E, Limpens J, Schuit E, Mol BW, Pajkrt E. Vaginal delivery in women with a low-lying placenta: a systematic review and meta-analysis. BJOG. 2019 Aug;126(9):1118-1126. doi: 10.1111/1471-0528.15622. Epub 2019 Mar 10.'}, {'pmid': '22612540', 'type': 'BACKGROUND', 'citation': 'Nakamura M, Hasegawa J, Matsuaka R, Mimura T, Ichizuka K, Sekizawa A, Okai T. Amount of hemorrhage during vaginal delivery correlates with length from placental edge to external os in cases with low-lying placenta whose length between placental edge and internal os was 1-2 cm. J Obstet Gynaecol Res. 2012 Aug;38(8):1041-5. doi: 10.1111/j.1447-0756.2011.01776.x. Epub 2012 May 21.'}, {'pmid': '22378482', 'type': 'BACKGROUND', 'citation': 'Ohira S, Kikuchi N, Kobara H, Osada R, Ashida T, Kanai M, Shiozawa T. Predicting the route of delivery in women with low-lying placenta using transvaginal ultrasonography: significance of placental migration and marginal sinus. Gynecol Obstet Invest. 2012;73(3):217-22. doi: 10.1159/000333309. Epub 2012 Mar 1.'}, {'pmid': '30260097', 'type': 'BACKGROUND', 'citation': 'Jauniaux E, Alfirevic Z, Bhide AG, Belfort MA, Burton GJ, Collins SL, Dornan S, Jurkovic D, Kayem G, Kingdom J, Silver R, Sentilhes L; Royal College of Obstetricians and Gynaecologists. Placenta Praevia and Placenta Accreta: Diagnosis and Management: Green-top Guideline No. 27a. BJOG. 2019 Jan;126(1):e1-e48. doi: 10.1111/1471-0528.15306. Epub 2018 Sep 27. No abstract available.'}, {'pmid': '11529986', 'type': 'BACKGROUND', 'citation': 'Oppenheimer L, Holmes P, Simpson N, Dabrowski A. Diagnosis of low-lying placenta: can migration in the third trimester predict outcome? Ultrasound Obstet Gynecol. 2001 Aug;18(2):100-2. doi: 10.1046/j.1469-0705.2001.00450.x.'}, {'pmid': '17346497', 'type': 'BACKGROUND', 'citation': 'Oppenheimer L; MATERNAL FETAL MEDICINE COMMITTEE. RETIRED: Diagnosis and management of placenta previa. J Obstet Gynaecol Can. 2007 Mar;29(3):261-266. doi: 10.1016/S1701-2163(16)32401-X.'}, {'pmid': '19733273', 'type': 'BACKGROUND', 'citation': 'Oppenheimer LW, Farine D. A new classification of placenta previa: measuring progress in obstetrics. Am J Obstet Gynecol. 2009 Sep;201(3):227-9. doi: 10.1016/j.ajog.2009.06.010. No abstract available.'}, {'pmid': '24764329', 'type': 'BACKGROUND', 'citation': 'Reddy UM, Abuhamad AZ, Levine D, Saade GR; Fetal Imaging Workshop Invited Participants. Fetal imaging: executive summary of a joint Eunice Kennedy Shriver National Institute of Child Health and Human Development, Society for Maternal-Fetal Medicine, American Institute of Ultrasound in Medicine, American College of Obstetricians and Gynecologists, American College of Radiology, Society for Pediatric Radiology, and Society of Radiologists in Ultrasound Fetal Imaging Workshop. J Ultrasound Med. 2014 May;33(5):745-57. doi: 10.7863/ultra.33.5.745.'}, {'pmid': '26244528', 'type': 'BACKGROUND', 'citation': 'Silver RM. Abnormal Placentation: Placenta Previa, Vasa Previa, and Placenta Accreta. Obstet Gynecol. 2015 Sep;126(3):654-668. doi: 10.1097/AOG.0000000000001005.'}, {'pmid': '34873004', 'type': 'DERIVED', 'citation': 'Ornaghi S, Colciago E, Vaglio Tessitore I, Abbamondi A, Antolini L, Locatelli A, Inversetti A, Pintucci A, Cetin I, Bracco B, Fabbri E, Sala V, Meroni M, Volpe G, Benedetti S, Bulfoni C, Marconi A, Lagrasta F, Paolini CL, Mazza E, Candiani M, Valsecchi L, Smid M, Pasi F, Pozzoni M, Castoldi M, Vignali M, Dal Molin G, Guarano A, Pellegrino A, Callegari C, Betti M, Lazzarin S, Prefumo F, Zanardini C, Parolin V, Catalano A, Barbolini E, Antonazzo P, Pignatti L, Tintoni M, Spelzini F, Martinelli A, Facchinetti F, Chiossi G, Vergani P. Mode of birth in women with low-lying placenta: protocol for a prospective multicentre 1:3 matched case-control study in Italy (the MODEL-PLACENTA study). BMJ Open. 2021 Dec 6;11(12):e052510. doi: 10.1136/bmjopen-2021-052510.'}]}, 'descriptionModule': {'briefSummary': 'Multicentre study; observational, longitudinal prospective, case-control', 'detailedDescription': 'This is a new protocol to evaluate the mode of birth in women with a low-lying placenta. In particular, we intend to propose a vaginal birth in women having a low-lying placenta with a distance between the inferior placental edge and the internal cervical os, called internal-os-distance (IOD) of \\> 5 mm, as assessed in the late III trimester using transvaginal sonography.\n\nDuration of the study:\n\n* Duration of the study: 54 months\n* Duration of enrollment: 42 months\n* Duration of follow-up completion of enrolled cases: 6 months\n* Duration of data analysis: 6 months\n\nStudy Design:\n\nDuring the II trimester scan, all women presenting a placenta located in the lower uterine segment will undergo evaluation by Transvaginal Sonography (TVS).\n\nIf a placenta previa or a low-lying placenta will be confirmed, the woman will be recruited and asked to participate in our study, by signing a written informed consent. In addition women attending the Maternity Triage with vaginal bleeding at \\< 316/7 weeks of gestation, with a diagnosis of placenta previa or low-lying placenta and not requiring an emergency delivery will be asked to participate and will be recruited after signing the informed consent.\n\nAn expert Obstetrician will perform the TVS as scheduled, after inviting the woman to void.\n\nThe assessment will include:\n\n* the measurement of the IOD (first caliper on the internal cervical os and second caliper on the inferior placental edge). In case of a marginal sinus, the distance between the internal cervical os and the marginal sinus will also be assessed;\n* the cervical length (defined as shortened if ≤25 mm);\n* the placental edge thickness, measured within 1 cm from the meeting point between the basal and the chorionic plate. The placental edge will be considered "thick" if \\> 1cm or if the angle is \\>45°.\n\nAll women with a resolution of a previa or low-lying placenta will be assessed in accordance with the protocol of each participating Maternity Unit, including a scan assessment at 38-39 weeks of gestation or within 28 days from the due date.\n\nCalculation of sample size / power:\n\nConsidering that the incidence of previa and low-lying placenta is approximately 2% at the II trimester scan and 0.4% at birth, and assuming a C.I. of 19% in the probability of vaginal birth in women with low-lying placenta/resolved low-lying (\\> 20 mm), 27 women will be needed for each participating Maternity Unit at the late III trimester scan. Anticipating a 10% drop out, 30 women will be needed to achieve a 95% statistical power to identify a clinically relevant difference in the rate of vaginal birth. This leads to the need of recruiting 150 women at the II trimester scan.\n\nCRF and data management:\n\nAll data will be recorded through CRF provided by the promoter center and the database will be based on Microsoft Excel.\n\nA sample of about 20-30 patients for each enrollment center is necessary to have a statistical power of 95% in detecting a clinically relevant difference in outcomes in the various study groups.\n\nAnalysis plan:\n\nDescriptive statistics will be performed for all variables evaluated in the study population. Variables will be described by mean and standard deviation if normally distributed, otherwise by median and interquantile range; proportions will be used for categorical variables. The quantitative variables, among the study groups defined by the IOD at the last TVS, will be compared by parametric and non-parametric tests, whereas the categorical variables will be compared using Pearson\'s chi2 test (Fisher exact test where appropriate). The analyses for the primary outcome measure will be performed among women admitted to labor. A multivariate analysis will be conducted to assess the association between obstetric variables and vaginal birth.\n\nA p-value\\<0.05 will be considered significant.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Women having a persisten low-lying placenta with an IOD between 6 and 20 mm and women with a resolved previa or low-lying placenta with an IOD \\> 20 mm who will be offered a trial of labor.\n\nA control group will be represented by women with a normal placental location at the II trimester scan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Minimum age of 18\n* Women with placenta previa or low-lying placenta confirmed by TVS at 19-23 6/7 weeks of gestation.\n\nWomen attending Maternity Triage with vaginal bleeding at \\< 32 weeks of gestation, with a diagnosis of placenta previa or low-lying placenta and not requiring an emergency delivery.\n\n* Women with a normally located placenta at the II trimester ultrasound scan, at 19-23 6/7 week of gestation (control group)\n* Single pregnancy\n* Signature of the informed consent to participate in the study\n\nNote: Women of the "control group" will be recruited in a 1:3 ratio. After the inclusion of 1 case, 3 women with a normally located placenta will be recruited, according to the parity of the woman representing the case (e.g.: 1 CASE= nulliparous woman, 3 CONTROLS= 3 nulliparous women).\n\nExclusion Criteria:\n\n* Suspected or confirmed invasive placentation (i.e., placenta accreta)\n* Vaginal bleeding requiring emergency delivery\n* Inability to meet the conditions set out in the study protocol'}, 'identificationModule': {'nctId': 'NCT04827433', 'acronym': 'MODEL-PLACENTA', 'briefTitle': 'Mode of Delivery in Women With Low-lying Placenta', 'organization': {'class': 'OTHER', 'fullName': 'University of Milano Bicocca'}, 'officialTitle': 'Mode of Delivery in Women With Low-lying Placenta: an Italian Multicentre Study', 'orgStudyIdInfo': {'id': 'MODEL-PLACENTA STUDY'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Women having a persistent low-lying placenta with an IOD between 6 and 20 mm', 'description': 'Women having a persistent low-lying placenta with an IOD between 6 and 20 mm who will be offered a vaginal birth, considering 3 subgroups: 1) 6-10 mm; 2) 11-20mm; 3) \\> 20 mm (resolution of previa or low-lying placenta)'}, {'label': 'Women with normal located placenta', 'description': 'Women with a normally located placenta at the II trimester scan will represent the control group.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bergamo', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Luisa Patane'", 'role': 'CONTACT'}, {'name': 'Luigi Frigerio', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Papa Giovanni XXIII', 'geoPoint': {'lat': 45.69601, 'lon': 9.66721}}, {'city': 'Brescia', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Edoardo Barbolini', 'role': 'CONTACT'}, {'name': 'Anna Catalano', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Fondazione Poliambulanza Istituto Ospedaliero', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Brescia', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Cristina Zanardini', 'role': 'CONTACT'}, {'name': 'Valentina Parolin', 'role': 'CONTACT'}, {'name': 'Federico Prefumo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Spedali Civili', 'geoPoint': {'lat': 45.53558, 'lon': 10.21472}}, {'city': 'Carate Brianza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Annalisa Inversetti', 'role': 'CONTACT'}, {'name': 'Anna Locatelli', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Vittorio Emanuele III', 'geoPoint': {'lat': 45.67574, 'lon': 9.23723}}, {'city': 'Cesena', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucrezia Pignatti', 'role': 'CONTACT'}, {'name': 'Patrizio Antonazzo', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale M. Bufalini di Cesena', 'geoPoint': {'lat': 44.1391, 'lon': 12.24315}}, {'city': 'Desio', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Armando Pintucci', 'role': 'CONTACT'}, {'name': 'Armando Pintucci', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Desio', 'geoPoint': {'lat': 45.61831, 'lon': 9.20249}}, {'city': 'Lecco', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Celia Callegari', 'role': 'CONTACT'}, {'name': 'Antonio Pellegrino', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Alessandro Manzoni', 'geoPoint': {'lat': 45.85589, 'lon': 9.39704}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisa Fabbri', 'role': 'CONTACT'}, {'name': 'Valentina Sala', 'role': 'CONTACT'}, {'name': 'Irene Cetin', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale dei Bambini "Vittore Buzzi"', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Enrico Ferrazzi', 'role': 'CONTACT'}, {'name': 'Enrico Ferrazzi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Mangiagalli', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Grazia Volpe', 'role': 'CONTACT'}, {'name': 'Mario Giuseppe Meroni', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Niguarda', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Valsecchi', 'role': 'CONTACT'}, {'name': 'Massimo Candiani', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale San Raffaele', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alice Guarano', 'role': 'CONTACT'}, {'name': 'Giulia Dal Molin', 'role': 'CONTACT'}, {'name': 'Michele Vignali', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Macedonio Melloni', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Milan', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Federica Lagrasta', 'role': 'CONTACT'}, {'name': 'Cinzia Paolini', 'role': 'CONTACT'}, {'name': 'Anna Maria Marconi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale San Paolo', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'city': 'Modena', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Giuseppe Chiossi', 'role': 'CONTACT'}, {'name': 'Fabio Facchinetti', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Policlinico di Modena', 'geoPoint': {'lat': 44.64783, 'lon': 10.92539}}, {'city': 'Monza', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Alessandra Abbamondi', 'role': 'CONTACT'}, {'name': 'Isadora VaglioTessitore', 'role': 'CONTACT', 'email': 'i.vagliotessitore@campus.unimib.it', 'phone': '3343200574'}, {'name': 'Sara Ornaghi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Obstetrics and Gynecology, MBBM Foundation at San Gerardo Hospital', 'geoPoint': {'lat': 45.58005, 'lon': 9.27246}}, {'city': 'Rimini', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Lucrezia Pignatti', 'role': 'CONTACT'}, {'name': 'Federico Spelzini', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Infermi di Rimini', 'geoPoint': {'lat': 44.05755, 'lon': 12.56528}}, {'city': 'Varese', 'status': 'NOT_YET_RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Antonella Cromi', 'role': 'CONTACT'}, {'name': 'Fabio Ghezzi', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ospedale Filippo Del Ponte', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}], 'centralContacts': [{'name': 'Elisabetta Colciago', 'role': 'CONTACT', 'email': 'elisabetta.colciago@gmail.com', 'phone': '0392332657'}, {'name': 'Isadora Vaglio Tessitore', 'role': 'CONTACT', 'email': 'i.vagliotessitore@campus.unimib.it', 'phone': '0392332657'}], 'overallOfficials': [{'name': 'Sara Ornaghi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'sara.ornaghi@unimib.it'}, {'name': 'Patrizia Vergani', 'role': 'STUDY_DIRECTOR', 'affiliation': 'patrizia.vergani@unimib.it'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Milano Bicocca', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}