Study of DDT and Loss of Clinically-Recognized Pregnancies in South Africa (NCT00878098) | Clinical Trial Compass
CompletedNot Applicable
Study of DDT and Loss of Clinically-Recognized Pregnancies in South Africa
South Africa513 participantsStarted 2009-06-01
Plain-language 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.
Who can participate
Age range
20 Years – 34 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
* 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
1. Aged 20-34 years
2. Plan to reside in the same (studied) village throughout participation in the study
3. Live in a village currently being studied
4. Have no previous pregnancy in the study
5. Have a positive spot pregnancy urine (hCG) test
ELIGIBILITY 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 higher than that of the first, and who are still pregnant 4 weeks after the first blood test.
2. 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 pr…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Trial details
NCT IDNCT00878098
SponsorNational Institute of Environmental Health Sciences (NIEHS)