- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00878098
Study of DDT and Loss of Clinically-Recognized Pregnancies in South Africa
Study of DDT and Loss of Clinically Recognized Pregnancies in South Africa
Background:
- In some countries, such as South Africa, the pesticide DDT is an important chemical for control of malaria-carrying mosquitoes. However, there is little evidence about the effects that it might have on human health.
- DDT has been associated with miscarriage and fetal loss in areas with high levels of exposure, but more research is needed to determine what levels of exposure are associated with loss of pregnancies.
Objectives:
- To examine the relationship between pre-pregnancy levels of DDT in the blood and the loss of clinically recognized pregnancies.
- To conduct a pilot study to evaluate data collection procedures for future research.
Eligibility:
- Women between 20 and 30 years of age who are not currently pregnant and who reside in villages in the Vhembe District in the northeastern part of South Africa.
Design:
Evaluation of eligibility:
- Short physical examination, with questionnaire about medical history, current living conditions, and daily life.
- Several blood samples will be taken for study and to test for anemia, elevated lead levels, malaria, syphilis, and human immunodeficiency virus (HIV).
- Half of the women will come from villages that are currently being sprayed with DDT, and half will come from villages that are not being sprayed.
Evaluation before and during pregnancy for subjects who become pregnant:
- Blood and urine test, including urine pregnancy test.
- Questions about recent menstrual history and sexual activity.
- Questions about medical history, including treatment for malaria.
- Pregnancy follow-up study, including blood draws, will be conducted regardless of whether the pregnancy is carried to term.
- Researchers will assess and adjust study parameters as needed.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Thulamela Municipality, South Africa
- Pretoria Academic Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
- ELIGIBILITY CRITERIA:
Enrollment criteria and follow-up criteria will be in two stages. Women will have to meet eligibility criteria to be enrolled for the study. Then, only those participants who meet the follow-up criteria will continue to be followed in the study until the end of their pregnancy. Those participants that do not meet the follow-up criteria will be withdrawn from the follow-up portion of the study.
ELIGIBILITY CRITERIA FOR ENROLLMENT
- Aged 20-34 years
- Plan to reside in the same (studied) village throughout participation in the study
- Live in a village currently being studied
- Have no previous pregnancy in the study
- Have a positive spot pregnancy urine (hCG) test
ELIGIBILITY CRITERIA FOR FOLLOW-UP
- Have two positive serum hCG tests at least one week apart, with the concentration of hCG in the second test being higher than that of the first, and who are still pregnant 4 weeks after the first blood test.
- The first serum hCG test is positive and reports a pregnancy loss within the first 4 weeks after the first blood test. An Inexscreen urine pregnancy test confirms that the participant is no longer pregnant at the second clinic visit (1 week after the first blood test) or at the third clinic visit (4 weeks after the first blood test).
EXCLUSION CRITERIA FOR FOLLOW-UP
1. Have two positive serum hCG tests at least one week apart, with the concentration of hCG in the second test being equal or lower than that of the first, and are still pregnant 4 weeks after the first blood test.
Study Plan
How is the study designed?
Design Details
Collaborators and Investigators
Investigators
- Principal Investigator: Gitanjali Taneja, Ph.D., National Institute of Environmental Health Sciences (NIEHS)
Publications and helpful links
General Publications
- Aneck-Hahn NH, Schulenburg GW, Bornman MS, Farias P, de Jager C. Impaired semen quality associated with environmental DDT exposure in young men living in a malaria area in the Limpopo Province, South Africa. J Androl. 2007 May-Jun;28(3):423-34. doi: 10.2164/jandrol.106.001701. Epub 2006 Dec 27.
- Cooper GS, Klebanoff MA, Promislow J, Brock JW, Longnecker MP. Polychlorinated biphenyls and menstrual cycle characteristics. Epidemiology. 2005 Mar;16(2):191-200. doi: 10.1097/01.ede.0000152913.12393.86.
- Bouwman H, Cooppan RM, Becker PJ, Ngxongo S. Malaria control and levels of DDT in serum of two populations in Kwazulu. J Toxicol Environ Health. 1991 Jun;33(2):141-55. doi: 10.1080/15287399109531514.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 999909115
- 09-E-N115
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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