- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00514280
Tobacco Smoke and Lead Exposure During Pregnancy
Tobacco Smoke and Lead Exposure During Pregnancy: Intervention to Reduce Effects on Birth-Weight and Gestational Age
This study will test whether a short interview session about lead and secondhand tobacco smoke can help pregnant women reduce their exposure to lead and secondhand smoke. Both lead and secondhand tobacco smoke can cause problems with a pregnancy. The best way to prevent exposure to lead and secondhand tobacco smoke is to recognize the sources and avoid them.
Non-smoking African-American and Hispanic pregnant women between 18 and 49 years of age who live in Washington, D.C. may be eligible for this study.
Participants are randomly assigned to one of two study groups. Both groups have a 30-minute one-on-one session with a member of the study staff. The content of the session differs between groups. In addition, all women undergo the following tests and procedures:
- Answer questions about themselves, their pregnancies, diet, home and smokers in the home.
- Requested to provide permission to obtain medical records of children older than 12 months of age who have ever been seen at Children's National Medical Center.
- Blood draws at least four times during the study: at the time of enrollment, during the second trimester of the pregnancy, during the third trimester, and at the time of delivery. Up to three optional blood samples may also be requested, one during each trimester of the pregnancy. Blood samples are used to measure lead, cotinine (a chemical the body makes out of nicotine) and hematocrit (a test for anemia).
- Collection of umbilical cord blood at the time of delivery.
- Answer questions after the delivery about the patient's health, the delivery and the baby.
Aperçu de l'étude
Statut
Description détaillée
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- National Institute of Child Health and Human Development (NICHD), 9000 Rockville
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
- INCLUSION CRITERIA:
Female
Pregnant
Age 18-49
Self-identified as African-American or Hispanic/Latino
Patient at participating clinic
DC resident at the time of enrollment
No tobacco use of any kind after week 13 of the current pregnancy
Able to read, write and understand English
Able to give informed consent
Able to cooperate with testing procedures
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Collaborateurs et enquêteurs
Publications et liens utiles
Publications générales
- Haddow JE, Knight GJ, Palomaki GE, McCarthy JE. Second-trimester serum cotinine levels in nonsmokers in relation to birth weight. Am J Obstet Gynecol. 1988 Aug;159(2):481-4. doi: 10.1016/s0002-9378(88)80114-5.
- Gonzalez-Cossio T, Peterson KE, Sanin LH, Fishbein E, Palazuelos E, Aro A, Hernandez-Avila M, Hu H. Decrease in birth weight in relation to maternal bone-lead burden. Pediatrics. 1997 Nov;100(5):856-62. doi: 10.1542/peds.100.5.856.
- Mannino DM, Homa DM, Matte T, Hernandez-Avila M. Active and passive smoking and blood lead levels in U.S. adults: data from the Third National Health and Nutrition Examination Survey. Nicotine Tob Res. 2005 Aug;7(4):557-64. doi: 10.1080/14622200500185264.
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 999907199
- 07-CH-N199
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