Tobacco Smoke and Lead Exposure During Pregnancy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00514280|
Recruitment Status : Completed
First Posted : August 9, 2007
Last Update Posted : July 2, 2017
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.
|Condition or disease|
|Lead Exposure in Pregnant Women Tobacco Smoke Exposure Pregnant Women|
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Tobacco Smoke and Lead Exposure During Pregnancy: Intervention to Reduce Effects on Birth-Weight and Gestational Age|
|Study Start Date :||August 2, 2007|
|Estimated Study Completion Date :||May 11, 2011|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00514280
|United States, Maryland|
|National Institute of Child Health and Human Development (NICHD), 9000 Rockville|
|Bethesda, Maryland, United States, 20892|