Spontaneous AbortionNCT00878098
Study of DDT and Loss of Clinically-Recognized Pregnancies in South Africa
An observational study of Spontaneous Abortion and Malaria, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in South Africa.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 34 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Spontaneous Abortion, Malaria, Pregnancy Outcome
- How many people
- 513 participants
- Where
- 1 siteSouth Africa
- Study dates
- 1 Jun 2009to 12 Jul 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 34 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of DDT and Loss of Clinically Recognized Pregnancies in South Africa
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.
Read more
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:
- 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.
Read the 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, 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.
- Conditions
- Spontaneous Abortion, Malaria, Pregnancy Outcome, Stillbirth, HIV Infections
- Keywords
- DDT, Malaria, Pregnancy Outcome, Spontaneous Abortion, HIV, Pregnancy
- Medical subject headings
- Abortion, Spontaneous, Malaria, Stillbirth, HIV Infections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study start1 Jun 2009
- Study completion12 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spontaneous AbortionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 513 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Gitanjali Taneja, Ph.D., Principal investigator, National Institute of Environmental Health Sciences (NIEHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00878098
- Sponsor's protocol ID
- 999909115
- Other IDs
- 09-E-N115
- Status last verified
- 12 Jul 2019
- First submitted
- 7 Apr 2009
- Last updated
- 18 Jul 2019
- Results posted
- No
Publications
Aneck-Hahn NH, Schulenburg GW, Bornman MS, Farias P, de Jager C. Impaired semen quality associated with environmental DDT exposure in young men living in a malaria area in the Limpopo Province, South Africa. J Androl. 2007 May-Jun;28(3):423-34. doi: 10.2164/jandrol.106.001701. Epub 2006 Dec 27.
PubMed 17192596Cooper GS, Klebanoff MA, Promislow J, Brock JW, Longnecker MP. Polychlorinated biphenyls and menstrual cycle characteristics. Epidemiology. 2005 Mar;16(2):191-200. doi: 10.1097/01.ede.0000152913.12393.86.
PubMed 15703533Bouwman H, Cooppan RM, Becker PJ, Ngxongo S. Malaria control and levels of DDT in serum of two populations in Kwazulu. J Toxicol Environ Health. 1991 Jun;33(2):141-55. doi: 10.1080/15287399109531514.
PubMed 2051491
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of DDT and Loss of Clinically Recognized Pregnancies in South Africa
- ClinicalTrials.gov ID
- NCT00878098
- Acronym / sponsor ID
- 999909115
- Conditions
- Spontaneous Abortion, Malaria, Pregnancy Outcome, Stillbirth, HIV Infections
- Keywords
- DDT, Malaria, Pregnancy Outcome, Spontaneous Abortion, HIV, Pregnancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 513 participants (actual)
- Lead sponsor
- National Institute of Environmental Health Sciences (NIEHS)US National Institutes of Health
- Study start
- 1 Jun 2009
- Study completion
- 12 Jul 2019
- First posted
- 8 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
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, 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.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 34 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Background: PubMed 17192596Aneck-Hahn NH, Schulenburg GW, Bornman MS, Farias P, de Jager C. Impaired semen quality associated with environmental DDT exposure in young men living in a malaria area in the Limpopo Province, South Africa. J Androl. 2007 May-Jun;28(3):423-34. doi: 10.2164/jandrol.106.001701. Epub 2006 Dec 27.
- Background: PubMed 15703533Cooper GS, Klebanoff MA, Promislow J, Brock JW, Longnecker MP. Polychlorinated biphenyls and menstrual cycle characteristics. Epidemiology. 2005 Mar;16(2):191-200. doi: 10.1097/01.ede.0000152913.12393.86.
- Background: PubMed 2051491Bouwman H, Cooppan RM, Becker PJ, Ngxongo S. Malaria control and levels of DDT in serum of two populations in Kwazulu. J Toxicol Environ Health. 1991 Jun;33(2):141-55. doi: 10.1080/15287399109531514.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gitanjali Taneja, Ph.D. principal investigator
National Institute of Environmental Health Sciences (NIEHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spontaneous Abortion and Malaria, run by National Institute of Environmental Health Sciences (NIEHS) at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00878098, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.