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Pregnancy Environment and Newborn Malformations (PENEW)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT01613638
First received: May 24, 2012
Last updated: August 5, 2014
Last verified: August 2014
  Purpose

Congenital malformations rate is about 3% in France. There are already 5 registries in France, covering about 16% of French births: Paris Registry, (about 38 000 births /year), Alsace Registry, (about 23 000 births/year), Rhône-Alpes Registry, (about 56 000 births/year), Auvergne Registry, (about 14 000 births/year), and la Réunion Registry. The aim of malformation registries is to carry out epidemiologic surveillance of congenital anomalies. The objectives are mainly to provide essential epidemiologic information on congenital anomalies, to facilitate the early warning of teratogenic exposures, to act as an information and resource centre regarding clusters, to provide data for research related to the causes and prevention of congenital anomalies.

A previous study was carried out in Brittany in 2008-2009, by the perinatal network of Ille et Vilaine, in collaboration with two research teams (Inserm U1085 and Inserm U 936), to record all cases of 4 types of congenital anomalies: congenital heart disease, spina bifida, diaphragmatic hernia and hypospadia. The results showed prevalence rates similar to those observed by Eurocat for spina bifida and diaphragmatic hernia, but a higher prevalence regarding congenital heart diseases and hypospadia. In this study the investigators could not determine whether this was due to a real higher frequency or to a particular exhaustiveness in the recording methodology.

There are hypothesis about the role of intrauterine exposure to pesticides, known as endocrine disruptors, and the risk of congenital genital anomalies. Brittany is an intensive agricultural area, and it is thus worth studying the impact of pesticides exposure on congenital anomalies.

There are also hypothesis on the impact of occupational exposure to solvents on congenital anomalies (Garlantezec 2009), and on the role of alcohol exposure (which concerns about 8% pregnant women in France) on oro-facial clefts and congenital heart diseases.

The Registry of congenital anomalies in Brittany was set up in 2010. The main aim is to study the impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.

Secondary objectives are to study other risk factors such as medicine intake, pregnancy illness…


Condition Intervention
Congenital Malformation
Other: meconium samples + maternal self-questionnaire

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Congenital Malformations and Intrauterine Pollutants Exposure (Alcohol, Solvents and Pesticides) in Brittany. Population Based Case-control Study Short Title : Malformations and Environment Acronym : PENEW for "Pregnancy Environment and Newborn Malformations"

Resource links provided by NLM:


Further study details as provided by Rennes University Hospital:

Primary Outcome Measures:
  • impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires. [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
    impact of intra-uterine exposure to solvents, pesticides and alcohol on the risk of congenital malformations diagnosed at births, by measuring the exposure both directly in meconium, and indirectly by questionnaires.


Secondary Outcome Measures:
  • other risk factors such as medicine intake, pregnancy illness… [ Time Frame: up to 48 hours ] [ Designated as safety issue: No ]
    other risk factors such as medicine intake, pregnancy illness…


Estimated Enrollment: 5000
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Congenital malformations

All livebirths, fetal deaths with gestational age (GA) ≥22 weeks and terminations of pregnancy (at any gestational age) after prenatal diagnosis of malformation.

  • born from mothers living in Brittany at delivery
  • with a congenital anomaly according to Eurocat criteria, diagnosed or suspected (and then confirmed) at birth
  • or with mild congenital heart defects, genital anomalies or hip dislocation diagnosed after birth (and before the age of one)
Other: meconium samples + maternal self-questionnaire
meconium samples + maternal self-questionnaire
control
2 controls per case will be included, corresponding to the first 2 births without congenital anomalies, with same sex and same birth place, following the case.
Other: meconium samples + maternal self-questionnaire
meconium samples + maternal self-questionnaire

Detailed Description:

Population based case-control study:

2 controls per case will be included, corresponding to the first 2 births without congenital anomalies, with same sex and same birth place, following the case.

INVESTIGATION METHODOLOGY :

All maternity in Brittany were proposed to participate. In each maternity, the referent practitioner informs the parents and includes the cases.

For each case and control, meconium samples and a mother's lock are collected by nurses or midwives, medical data are collected from medical reports by the registry investigator, and a self-questionnaire is filled by the mother.

Meconium samples are immediately stored in a freezer (-20°C), secondarily transported to a biological storage centre at the university hospital and then dispatched to specialised laboratories for toxicological analyses: INERIS (for solvents and pesticides) and Toxicology Unit, University hospital Rennes (for Alcohol).

For dead fetuses (stillbirths or termination of pregnancy), meconium will be collected by the pathologist in charge of the autopsy, after parents' consent.

Evaluation of exposure:

  • direct evaluation: by toxicological analyses in meconium samples: Alcohol, Solvents and pesticides
  • indirect evaluation: by maternal self-questionnaire including data on occupational and domestic exposures, hobbies, life habits…, precise address (for spatial location)

Particular cases: mild congenital heart defects, genital anomalies and hip dislocation diagnosed later after birth (after the period oh meconium and before the age of one): these cases will be spotted through the Registry, there won't be any biological sample for them, but mothers will be contacted by main investigator and medical data and mother questionnaires will be collected. There won't be any control included for those cases included after birth.

Associations between exposure risk factors (alcohol, solvents and pesticides) and the risk of congenital malformations will be estimated by a multivariate analysis.

  • Exposure to solvents will be estimated by assay in meconium and by occupational questionnaire
  • Exposure to alcohol will be estimated by assay of Ethylglucuronide et de Ethylsulfate in meconium.
  • Exposure to pesticides will be estimated by assay in meconium, by questionnaire and by spatial location.
  Eligibility

Ages Eligible for Study:   up to 12 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

All live births, fetal deaths with gestational age (GA) ≥22 weeks and terminations of pregnancy (at any gestational age) after prenatal diagnosis of malformation.

  • born from mothers living in Brittany at delivery
  • with a congenital anomaly according to Eurocat criteria, diagnosed or suspected (and then confirmed) at birth
  • or with mild congenital heart defects, genital anomalies or hip dislocation diagnosed after birth (and before the age of one)

Non inclusion criteria :

  • Spontaneous abortion before 22 weeks gestational age.
  • Mother with legal protection (guardianship)

Exclusion Criteria:

  • Prenatally suspected malformations, which are not confirmed by postnatal screening or clinical evolution
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01613638

Contacts
Contact: Florence Rouget, MD florence.rouget@chu-rennes.fr

Locations
France
Brest University Hospital Recruiting
Brest, Brittany, France, 29609
Contact: Michel Collet, MD         
Principal Investigator: Michel Collet, MD         
Sub-Investigator: Philippe Parent, MD         
Sub-Investigator: Jacques Sizun, MD         
Sub-Investigator: Pascale Marcorelles, MD         
Clinique Pasteur Recruiting
Brest, Brittany, France, 29200
Contact: Alain Hassoun, MD         
Principal Investigator: Alain Hassoun, MD         
Polyclinique de Keraudren Recruiting
Brest, Brittany, France, 29200
Contact: David Somerville, MD         
Principal Investigator: David Somerville, MD         
Principal Investigator: Mohamed-Salah Benkhelifa, MD         
Dinan Hospital Recruiting
Dinan, Brittany, France, 22101
Contact: Michel Turban, MD         
Principal Investigator: Michel Turban, MD         
Fougères Hospital Recruiting
Fougères, Brittany, France, 35300
Contact: Philippe Lefevre, MD         
Principal Investigator: Philippe Lefevre, MD         
Lannion Hospital Recruiting
Lannion, Brittany, France, 22303
Contact: Philippe Rebour, MD         
Principal Investigator: Philippe Rebour, MD         
Lorient Hospital Recruiting
Lorient, Brittany, France, 56322
Contact: Philippe Tillaut, MD         
Principal Investigator: Philippe Tillaut, MD         
Principal Investigator: Anne-Laure Joncquez-Puybasset, MD         
Ploermel Hospital Recruiting
Ploermel, Brittany, France, 56804
Contact: Marie-Agnès Guillou, MD         
Principal Investigator: Marie-Agnès Guillou, MD         
Principal Investigator: Marie-Paule Thomas, MD         
Pontivy Hospital Recruiting
Pontivy, Brittany, France, 56306
Contact: Patrick Vallée, MD         
Principal Investigator: Patrick Vallée, MD         
Quimper Hospital Recruiting
Quimper, Brittany, France, 29000
Contact: Charles Bellot, MD         
Principal Investigator: Charles Bellot, MD         
Redon Hospital Recruiting
Redon, Brittany, France, 35603
Contact: Joseph Abi-Fadel, MD         
Principal Investigator: Joseph Abi-Fadel, MD         
Clinique La sagesse Recruiting
Rennes, Brittany, France, 35043
Contact: Isabelle Blanchot, MD         
Principal Investigator: Isabelle Blanchot, MD         
Rennes University Hospital Recruiting
Rennes, Brittany, France
Contact: Florence Rouget, MD         
Principal Investigator: Florence Rouget, MD         
Sub-Investigator: Patrick Pladys, MD         
Sub-Investigator: Patrice Poulain, MD         
Sub-Investigator: Laurent Pasquier, MD         
Sub-Investigator: Edouard Habonimana, MD         
Sub-Investigator: Philippe Loget, MD         
Polyclinique du Littoral Recruiting
Saint-Brieuc, Brittany, France, 22003
Contact: Joseph Magagi, MD         
Principal Investigator: Joseph Magagi, MD         
Principal Investigator: Gilles Buisson, MD         
Saint-Brieuc Hospital Recruiting
Saint-Brieuc, Brittany, France, 22000
Contact: Claire Combescure, MD         
Principal Investigator: Claire Combescure, MD         
Sub-Investigator: Jean-Baptiste Muller, MD         
Saint-Grégoire Hospital Recruiting
Saint-Grégoire, Brittany, France, 35760
Contact: Joëlle Gueguen, MD         
Principal Investigator: Joëlle Gueguen, MD         
Saint-Malo Hospital Recruiting
Saint-Malo, Brittany, France, 35400
Contact: Maria Vernis, MD         
Principal Investigator: Maria Vernis, MD         
Clinique Océane Recruiting
Vannes, Brittany, France, 56000
Contact: Claire Duhaut, MD         
Principal Investigator: Claire Duhaut, MD         
Principal Investigator: Etienne Hourdry, MD         
Vannes Hospital Recruiting
Vannes, Brittany, France, 56000
Contact: Hubert Journel, MD         
Principal Investigator: Hubert Journel, MD         
Principal Investigator: Marie-Paule Thomas, MD         
Vitré Hospital Recruiting
Vitré, Brittany, France, 35506
Contact: Dominique Chaumet, MD         
Principal Investigator: Dominique Chaumet, MD         
Sponsors and Collaborators
Rennes University Hospital
Investigators
Principal Investigator: Florence Rouget, MD Rennes University Hospital
Principal Investigator: Philippe Lefevre, MD Fougères Hospital
Principal Investigator: Joëlle Gueguen, MD Saint-Grégoire Hospital
Principal Investigator: Isabelle Blanchot, MD Clinique La Sagesse - Rennes
Principal Investigator: Maria Vernis, MD Saint-Malo Hospital
Principal Investigator: Dominique Chaumet, MD Vitré Hospital
Principal Investigator: Joseph Abi-Fadel, MD Redon Hospital
Principal Investigator: Philippe Rebour, MD Lannion Hospital
Principal Investigator: Michel Turban, MD Dinan Hospital
Principal Investigator: Claire Combescure, MD Saint-Brieuc Hospital
Principal Investigator: Joseph Magagi, MD Polyclinique du Littoral - Saint-Brieuc
Principal Investigator: Michel Collet, MD University Hospital, Brest
Principal Investigator: David Somerville, MD Polyclinique de Keraudren - Brest
Principal Investigator: Alain Hassoun, MD Clinique Pasteur - Brest
Principal Investigator: Charles Bellot, MD Quimper Hospital
Principal Investigator: Philippe Tillaut, MD Lorient Hospital
Principal Investigator: Hubert Journel, MD Vannes Hospital
Principal Investigator: Claire Duhaut, MD Clinique Océane - Vannes
Principal Investigator: Patrick Vallée, MD Pontivy Hospital
Principal Investigator: Marie-Agnès Guillou, MD Ploermël Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT01613638     History of Changes
Other Study ID Numbers: PHRC/10-02 - PENEW, B110827-40, 11/22-811, 2010-A01445-34
Study First Received: May 24, 2012
Last Updated: August 5, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
France: Committee for the Protection of Personnes
France: Direction Générale de la Santé
France: The Commission nationale de l’informatique et des libertés

Keywords provided by Rennes University Hospital:
congenital malformation
pollutants

Additional relevant MeSH terms:
Congenital Abnormalities

ClinicalTrials.gov processed this record on November 20, 2014