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| Sponsor: | National Institute of Environmental Health Sciences (NIEHS) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00878098 |
Purpose
Background:
Objectives:
Eligibility:
Design:
Evaluation of eligibility:
Evaluation before and during pregnancy for subjects who become pregnant:
| Condition |
|---|
|
Spontaneous Abortion Malaria Pregnancy Outcome Stillbirth HIV Infections |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Study of DDT and Loss of Clinically Recognized Pregnancies in South Africa |
| Estimated Enrollment: | 2805 |
| Study Start Date: | April 2009 |
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, South Africa. The initial protocol (which will be referred to as Part 1) planned to enroll 2,400 non-pregnant women, draw blood for measurement of DDT exposure, and follow 1,200 pregnant participants to ascertain occurrence of miscarriage. An initial two-year pilot of 850 non-pregnant women was proposed to evaluate field procedures, recruitment strategies and the reproducibility of DDT levels. Of the 444 women enrolled in the first 10 months of the pilot of Part 1, only 27 have become pregnant. Although the field procedures have been well executed, the number of pregnancies has been low. Based upon the experience to date, the approach taken so far is unlikely to generate enough pregnancies to monitor the occurrence of miscarriages. Therefore, the revised protocol (referred to as Part 2) will modify enrollment criteria to include only pregnant women who are in the early stages of pregnancy, confirmed by rising human chorionic gonadotropin (hCG) blood levels taken 1 week apart or pregnant women who have a pregnancy loss within 4 weeks of enrollment. Participants who were enrolled in Part 1 of the pilot, who are still not pregnant at implementation of Part 2 will be withdrawn from the study, while pregnant participants from Part 1 will continue to be followed. In Part 2, a total of 2,400 pregnant women will be enrolled. Only those who meet the follow-up criteria (n=1,200) will be followed to determine the outcome of pregnancy. The reproducibility study of DDT levels amongst a subset of 200 women will also be dropped and replaced with an analysis using specimens that were collected in Part 1.
Eligibility| Ages Eligible for Study: | 20 Years to 34 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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
ELIGIBILITY CRITERIA FOR FOLLOW-UP
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.
Contacts and Locations| South Africa | |
| Pretoria Academic Hospital | |
| Thulamela Municipality, South Africa | |
| Principal Investigator: | Matthew Longnecker, M.D. | National Institute of Environmental Health Sciences (NIEHS) |
More Information
| ClinicalTrials.gov Identifier: | NCT00878098 History of Changes |
| Other Study ID Numbers: | 999909115, 09-E-N115 |
| Study First Received: | April 7, 2009 |
| Last Updated: | May 3, 2012 |
| Health Authority: | United States: Federal Government |
|
DDT Malaria Pregnancy Outcome |
Spontaneous Abortion HIV Pregnancy |
|
Abortion, Spontaneous HIV Infections Acquired Immunodeficiency Syndrome Malaria Pregnancy Complications Lentivirus Infections Retroviridae Infections RNA Virus Infections |
Virus Diseases Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Protozoan Infections Parasitic Diseases |