Influence of Social and Environmental Factors on Women's Reproductive Function in a Maya Community of Guatemala
The Influence of Social and Environmental Factors on Fecundability in a Maya Community of Guatemala
This study will explore the influence of social and environmental factors, such as stress, nutrition, health status, etc., on women's reproductive function.
Married Mayan women 16-42 years of age who live in the rural highlands of Guatemala and who have given birth to at least one child are eligible to participate in this study.
Participants are interviewed about their demographic, social, family, personal, health, reproductive and economic situations. They have saliva and urine samples collected three times a week for up to 1 year. Their nutritional and health status is assessed monthly.
調査の概要
状態
条件
詳細な説明
Background & Objectives: To explore the influence that social and environmental factors have on women's reproductive function. The general hypothesis is that deterioration in the quality of women's reproductive environment (e.g. psychosocial stress, nutritional status, health status, etc.) would have deleterious effects on fecundability and early pregnancy maintenance.
Study population: Data were collected from Mayan women in Guatemala. The reduced ethnic and socio-economic heterogeneity of this traditional population, as compared to that of an industrialized society, increased the robustness of the study design.
Inclusion and exclusion criteria: The goal was to evaluate fecundability and early pregnancy, thus, only women who met all six of the following criteria were recruited: (1) cohabitating with husband, (2), parity greater than or equal to 1 (to reduce the number of infertile participants), (3) being between 16-42 years of age (women aged greater than or equal to 16 are considered adults in this Mayan community. In fact, the first two pre-requisite to participate were that women were married and had given birth to at least one child), (4) not pregnant at the onset of the study (5) not using any form of contraception, and (6) last birth greater than six months prior to the onset of the study.
Human Subject Protection: Participants' recruitment was voluntary. Consent was obtained orally because most participants were illiterate, Privacy and confidentiality were assured, and participants were informed that they could discontinue their participation at any time with no cost or consequences to them. No deception, or covert observation, or interviewing of children were involved. I.D. numbers (not names) were used in recording the data. Names of participants are kept separately from data. All names and data files are kept in password protected NIEHS-computer or CDs stored under lock and key. Only ID numbers are used in analyses. Names are stored in case future research is needed. We have no current plants for research that involves re-contacting participants. Such research would entail a separate IRB application.
Design and outcome parameters: Saliva and first-morning urine specimens plus interview data were collected every other day, for a total of three times each week for up to one year. Participants' stress is measured via interview instruments as well as salivary and urinary free cortisol levels. Fecundability and early pregnancy are monitored through the determination of progesterone and estrone conjugates, luteinizing and follicle stimulating hormones, and chorionic gonadotropin. Nutritional and health assessments were achieved through standard medical and anthropometric procedures. Lactation, frequency and timing of intercourse, socio-economic status, and participant's life and reproductive history were all assessed via interview instruments. The data collection phase of this project is finished. Specimen and data analyses will continue including further assessment of stress, fecundability, and early pregnancy. Specimen analyses will be conducted by our collaborator Dr. Barry G. England at the University of Michigan under a separated University of Michigan IRB approval.
研究の種類
連絡先と場所
研究場所
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Michigan
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Ann Arbor、Michigan、アメリカ、48109-0624
- University of Michigan
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North Carolina
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Research Triangle Park、North Carolina、アメリカ、27709
- NIEHS, Research Triangle Park
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
- ELIGIBILITY CRITERIA:
Women who met all five of the following criteria were invited to participate: (1) cohabitating with husband, (2) not pregnant at the onset of the study, (3) parity greater than or equal to 1, (4) not using any form of contraception, and (5) last birth greater than six months prior to the onset of the study.
研究計画
研究はどのように設計されていますか?
協力者と研究者
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 999906145
- 06-E-N145
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妊娠初期の臨床試験
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Western University, Canadaまだ募集していません