Status:
COMPLETED
Study of DDT and Loss of Clinically-Recognized Pregnancies in South Africa
Lead Sponsor:
National Institute of Environmental Health Sciences (NIEHS)
Conditions:
Spontaneous Abortion
Malaria
Eligibility:
FEMALE
20-34 years
Brief Summary
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 ...
Detailed Description
In this study, the primary goal is to examine the relationship between DDT (dichlorodiphenyltrichloroethane) levels and the odds of loss of clinically-recognized pregnancies amongst women in Limpopo, ...
Eligibility Criteria
Inclusion
- 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 Those participants that do not meet the follow-up criteria will be withdrawn from the follow-up portion of the study.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.
Exclusion
Key Trial Info
Start Date :
June 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 12 2019
Estimated Enrollment :
513 Patients enrolled
Trial Details
Trial ID
NCT00878098
Start Date
June 1 2009
End Date
July 12 2019
Last Update
July 18 2019
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Pretoria Academic Hospital
Thulamela Municipality, South Africa