Study of DDT and Loss of Clinically-Recognized Pregnancies in South Africa
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|ClinicalTrials.gov Identifier: NCT00878098|
Recruitment Status : Completed
First Posted : April 8, 2009
Last Update Posted : July 18, 2019
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- 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.
- 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.
- 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.
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.
|Condition or disease|
|Spontaneous Abortion Malaria Pregnancy Outcome Stillbirth HIV Infections|
|Study Type :||Observational|
|Actual Enrollment :||513 participants|
|Official Title:||Study of DDT and Loss of Clinically Recognized Pregnancies in South Africa|
|Study Start Date :||June 1, 2009|
|Study Completion Date :||July 12, 2019|
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|Ages Eligible for Study:||20 Years to 34 Years (Adult)|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||Yes|
- 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.
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): NCT00878098
|Pretoria Academic Hospital|
|Thulamela Municipality, South Africa|
|Principal Investigator:||Gitanjali Taneja, Ph.D.||National Institute of Environmental Health Sciences (NIEHS)|
|Responsible Party:||National Institute of Environmental Health Sciences (NIEHS)|
|Other Study ID Numbers:||
|First Posted:||April 8, 2009 Key Record Dates|
|Last Update Posted:||July 18, 2019|
|Last Verified:||July 12, 2019|
Vector Borne Diseases
Female Urogenital Diseases and Pregnancy Complications