Influence of Social and Environmental Factors on Women's Reproductive Function in a Maya Community of Guatemala
Condition: Early Pregnancy
Study type: Observational

Summary: 
      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.
    

Detailed description: 
      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.
    

Keywords: Menstrual Cycles; Early Pregnancy; Reproductive Hormones; Stress; Adrenal Function