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Study of DDT and Loss of Clinically-Recognized Pregnancies in South Africa

NCT00878098 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 513

Last updated 2019-07-18

No results posted yet for this study

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 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:

1. Short physical examination, with questionnaire about medical history, current living conditions, and daily life.
2. 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:

1. Blood and urine test, including urine pregnancy test.
2. Questions about recent menstrual history and sexual activity.
3. 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.

Conditions

  • Spontaneous Abortion
  • Malaria
  • Pregnancy Outcome
  • Stillbirth
  • HIV Infections

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Gitanjali Taneja, Ph.D. · National Institute of Environmental Health Sciences (NIEHS)

Eligibility

Min Age
20 Years
Max Age
34 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-06-01
Completion
2019-07-12

Countries

  • South Africa

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00878098 on ClinicalTrials.gov