Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00340782
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2006-06-19
Brief Title:
Influence of Social and Environmental Factors on Womens Reproductive Function in a Maya Community of Guatemala
Sponsor:
National Institute of Environmental Health Sciences NIEHS
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Influence of Social and Environmental Factors on Fecundability in a Maya Community of Guatemala
Status:
COMPLETED
Status Verified Date:
2008-04-21
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will explore the influence of social and environmental factors such as stress nutrition health status etc on womens 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
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 womens reproductive function The general hypothesis is that deterioration in the quality of womens reproductive environment eg 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 ID 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 participants 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
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 ID 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 participants 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-E-N145 | None | None | None |