Lead Exposure in Pregnant WomenNCT00514280
Tobacco Smoke and Lead Exposure During Pregnancy
An observational study of Lead Exposure in Pregnant Women and Tobacco Smoke Exposure Pregnant Women, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 49 years, women only
- Conditions the study is for
- Lead Exposure in Pregnant Women, Tobacco Smoke Exposure Pregnant Women
- How many people
- 400 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Aug 2007to 11 May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 49 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Female
- Pregnant
- Age 18-49
- Self-identified as African-American or Hispanic/Latino
- Patient at participating clinic
- DC resident at the time of enrollment
Show all 10Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institute of Child Health and Human Development (NICHD), 9000 Rockville
Bethesda, Maryland, 20892
About this study
Official title: 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.
Read more
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.
Read the detailed description
Prenatal exposure to lead and tobacco has been shown to cause long-term adverse effects to the fetus and child, including decreased birthweight and premature delivery. These effects have been shown even at very low exposure levels. Since both exposures can be modified, many experts recommend screening for and counseling to prevent or reduce these exposures as part of routine prenatal care. The high infant mortality in the District of Columbia (DC) (10.2 deaths per 1,000 live births, versus 6.2 deaths per 1,000 births nationally) is incompletely understood, but disparities in health and healthcare access for minority populations, premature delivery, and low birthweight are likely contributors. Several studies and prevention programs have addressed smoking by and secondhand tobacco smoke (SHS) exposure of pregnant women living in DC in an effort to reduce the infant mortality rate, but none have addressed elevated blood lead levels (BLL) or the effects of exposure to both elevated BLL and SHS. Since DC children have high rates of both elevated BLL and SHS exposure, compared to the US population, we hypothesize that pregnant women in DC have similar high rates of elevated BLL and SHS exposure, AND that these exposures contribute to the high rates of low birthweight and decreased gestational age, and therefore to the rate of infant mortality in DC. The primary aim of this study is to determine the effectiveness of a screening and secondary prevention intervention for elevated blood lead and SHS exposure of low income, pregnant women living in Washington, DC.
- Keywords
- Lead and Smoke Study in D.C., Birth Weight, Gestational Age, Lead, Tobacco Smoke
- Medical subject headings
- Birth Weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2007 (estimated)
- Study start2 Aug 2007
- Study completion11 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Lead Exposure in Pregnant WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Other
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514280
- Sponsor's protocol ID
- 999907199
- Other IDs
- 07-CH-N199
- Status last verified
- 11 May 2011
- First submitted
- 8 Aug 2007
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 3407708Gonzalez-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.
PubMed 9346987Mannino 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.
PubMed 16085527
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tobacco Smoke and Lead Exposure During Pregnancy: Intervention to Reduce Effects on Birth-Weight and Gestational Age
- ClinicalTrials.gov ID
- NCT00514280
- Acronym / sponsor ID
- 999907199
- Keywords
- Lead and Smoke Study in D.C., Birth Weight, Gestational Age, Lead, Tobacco Smoke
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 2 Aug 2007
- Study completion
- 11 May 2011
- First posted
- 9 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Prenatal exposure to lead and tobacco has been shown to cause long-term adverse effects to the fetus and child, including decreased birthweight and premature delivery. These effects have been shown even at very low exposure levels. Since both exposures can be modified, many experts recommend screening for and counseling to prevent or reduce these exposures as part of routine prenatal care. The high infant mortality in the District of Columbia (DC) (10.2 deaths per 1,000 live births, versus 6.2 deaths per 1,000 births nationally) is incompletely understood, but disparities in health and healthcare access for minority populations, premature delivery, and low birthweight are likely contributors. Several studies and prevention programs have addressed smoking by and secondhand tobacco smoke (SHS) exposure of pregnant women living in DC in an effort to reduce the infant mortality rate, but none have addressed elevated blood lead levels (BLL) or the effects of exposure to both elevated BLL and SHS. Since DC children have high rates of both elevated BLL and SHS exposure, compared to the US population, we hypothesize that pregnant women in DC have similar high rates of elevated BLL and SHS exposure, AND that these exposures contribute to the high rates of low birthweight and decreased gestational age, and therefore to the rate of infant mortality in DC. The primary aim of this study is to determine the effectiveness of a screening and secondary prevention intervention for elevated blood lead and SHS exposure of low income, pregnant women living in Washington, DC.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 49 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Female
- Pregnant
- Age 18-49
- Self-identified as African-American or Hispanic/Latino
- Patient at participating clinic
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 3407708Haddow 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.
- Background: PubMed 9346987Gonzalez-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.
- Background: PubMed 16085527Mannino 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lead Exposure in Pregnant Women and Tobacco Smoke Exposure Pregnant Women, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00514280, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.