CHIMERE - Mother-to-Child Chikungunya virus infection: an ambispective cohort study 
Head :
Gérardin Patrick, Centre d'Investigation Clinique (CIC 1410) - ex Centre d'Investigation Clinique - Epidémiologie Clinique (CIE2)
Fritel Xavier, Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Poitiers, Université de Poitiers, Faculté de Médecine et Pharmacie. http://medphar.univ-poitiers.fr/CESP UMR Inserm U1018, Equipe 7 : Genre, Santé Sexuelle et Reproductive.
Fritel Xavier, Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Poitiers, Université de Poitiers, Faculté de Médecine et Pharmacie. http://medphar.univ-poitiers.fr/CESP UMR Inserm U1018, Equipe 7 : Genre, Santé Sexuelle et Reproductive.
Last update : 10/01/2018 | Version : 2 | ID : 23302
| General | |
| Identification | |
| Detailed name | Mother-to-Child Chikungunya virus infection: an ambispective cohort study |
| Sign or acronym | CHIMERE |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL 1836406, CPP Tours 2006/2007 |
| General Aspects | |
| Medical area |
Infectious diseases |
| Keywords | Chikungunya virus; pregnancy; obstetrics; perinatal medicine; mother; neonate; mother-to-child transmission; pediatrics; children; encephalitis; encephalopathy; neurodevelopmental outcome; sequelae; cohort studies |
| Scientific investigator(s) (Contact) | |
| Name of the director | Gérardin |
| Surname | Patrick |
| Address | Centre de Recherche Médicale et en Santé - CHU Réunion - Site du Groupe Hospitalier Sud Réunion - avenue du Président François Mitterrand - BP 350 - 97448 Saint Pierre Cedex - île de la Réunion |
| Phone | + (262) 262.35.90.00 + 5.42.71 ; + (262) 262.35.90.00 + 5.83.94 ; + (262) 262.35.90.00 + 5.87.53 |
| patrick.gerardin@chu-reunion.fr | |
| Unit | Centre d'Investigation Clinique (CIC 1410) - ex Centre d'Investigation Clinique - Epidémiologie Clinique (CIE2) |
| Organization | CHU de La Réunion / Inserm /Université de La Réunion / Union Régionale des Médecins Libéraux de l'Océan |
| Name of the director | Fritel |
| Surname | Xavier |
| Address | Gynécologue-Obstétricien, Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Poitiers, 2 rue de la Milétrie, 86000 Poitiers, France |
| Phone | + (33) 5.49.44.33.60. ; + (33) 5.49.44.39.45 |
| xavier.fritel@univ-poitiers.fr | |
| Unit | Service de Gynécologie-Obstétrique et Médecine de la Reproduction, CHU de Poitiers, Université de Poitiers, Faculté de Médecine et Pharmacie. http://medphar.univ-poitiers.fr/CESP UMR Inserm U1018, Equipe 7 : Genre, Santé Sexuelle et Reproductive. |
| Organization | 2224Inserm CIC-P 1402 Centre d’Investigation Clinique Plurithématique du CHU de Poitiers. http://cic0802.labo.univ-poitiers.fr |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Details | Reacting network for the Chikungunya in French West Indies and Guyana |
| Funding | |
| Funding status |
Public |
| Details | PHRC grant 2006 |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | CHU de la Réunion |
| Organisation status |
Public |
| Additional contact | |
| Main features | |
| Type of database | |
| Type of database |
Study databases |
| Study databases (details) |
Cohort study |
| Database recruitment is carried out by an intermediary |
A selection of health institutions and services |
| Database recruitment is carried out as part of an interventional study |
No |
| Additional information regarding sample selection. | Ambispective: prospective enrollement of consecutive mother-infant pairs from April, 2006 to November, 2006; retrospective enrollment of 33 additional mother-infant pairs whose child had been infected between June 2005 to April 2006. |
| Database objective | |
| Main objective |
1- Primary objective: to assess the prevalence and the neurodevelopmental outcomes of maternal-fetal chikungunya infection ; 2-Secundary objectives: to decipher the mechanisms and risk factors of mother-to-child chikungunya virus transmission; to describe the chikungunya virus in the pregnant woman and in the neonate;
to propose a guideline for diagnosis and treatment of infections over pregnancy, childbirth and neonatal periods; to valid the virological diagnosis in the neonate using cord blood RT-PCRs; to study viral strains; to describe in children exposed in utero to maternal infection the kinetics of seroreversion of maternal transplacental IgG antibodies. |
| Inclusion criteria | Maternal study: pregnant women with life insurance cover; Child study: children born from women enrolled in t the maternal cohort. Inclusion whatever the pregnancy story and the exposure the first two months, then only the exposed women reporting a chikungunya attack the next six following months. |
| Population type | |
| Age |
Newborns (birth to 28 days) Infant (28 days to 2 years) |
| Population covered |
General population |
| Gender |
Woman |
| Geography area |
Departmental |
| French regions covered by the database |
La Réunion |
| Detail of the geography area | Cohort study conducted in four public maternities: Saint Denis, Saint Louis, Saint Paul, Saint Pierre; one semi-public semi-private maternity: Saint Benoît; one private maternity: Sainte Clotilde |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 06/2005 |
| Date of last collection (YYYY or MM/YYYY) | 10/2008 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 1433 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data Administrative data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Mothers: inclusions, clinical examinations and anthropometric measures during pregnancy and/or at childbirth. Children: inclusions and clinical examinations and anthropometric measures at birth, 9-12 months (CLAMS and babyvision), 18-24 months (revised Brunet-Lezine DQ) |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Mothers: inclusions, clinical examinations and anthropometric measures during pregnancy and/or at childbirth. Children: inclusions and clinical examinations and anthropometric measures at birth, 9-12 months (CLAMS and babyvision), 18-24 months (revised Brunet-Lezine DQ) |
| Paraclinical data (detail) | Mothers: virological and serological examinations during pregnancy and/or at childbirth. Children: virological and serological examinations at birth, then serological examinations exclusively at 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months. |
| Biological data (detail) | Mothers: blood numeration and formula at childbirth; children: blood numeration and formula at birth |
| Administrative data (detail) | Hospital stays |
| Presence of a biobank |
No |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Data collection method | Data collected by hospital-based gynecologists-obstetricians, midwives, neonatologists-pediatricians, psychometrists, neuropsychologists in CAMSP centers at the different time-points of follow-up (see above). |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Children: clinical examinations and anthropometric measures at birth by neonatologists-pediatricians at 9-12 months (CLAMS and babyvision by pyschometrists), at 18-24 months (revised Brunet-Lezine DQ by blind neuropsychologist of the infectious status);Serological examinations at 3 weeks, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.sciencedirect.com/science/article/pii/S1201971208001586 |
| Link to the document | http://wwwnc.cdc.gov/eid/article/16/3/pdfs/09-1403.pdf |
| Link to the document | http://tinyurl.com/HAL-CHIMERE |
| Description | List of publications in HAL |
| Link to the document | http://tinyurl.com/Pubmed-CHIMERE |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | modalities of access to the database in progress. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
