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

NCT00878098 | Completed

• 2 other identifiers: 99990911509-E-N115
• Study Type: observational
• Target: 513
• Locations: 1 country
• Sites: 1

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 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.

Conditions

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

Keywords

DDT; Malaria; Pregnancy Outcome; Spontaneous Abortion; HIV; Pregnancy

Eligibility Criteria

• Age: 20 Years - 34 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• \. 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.

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

Pretoria Academic Hospital

Thulamela Municipality, South Africa

Location

Related Publications (3)

• 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.

  PMID: 17192596 BACKGROUND

• Cooper 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.

  PMID: 15703533 BACKGROUND

• Bouwman 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.

  PMID: 2051491 BACKGROUND

MeSH Terms

Conditions

Abortion, Spontaneous; Malaria; Stillbirth; HIV Infections

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Protozoan Infections; Parasitic Diseases; Infections; Mosquito-Borne Diseases; Vector Borne Diseases; Fetal Death; Death; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Officials

• Gitanjali Taneja, Ph.D.

  National Institute of Environmental Health Sciences (NIEHS)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2009
• First Posted: April 8, 2009
• Study Start: June 1, 2009
• Study Completion: July 12, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07-12

Locations

ZA (1)