NCT00340782

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 2006

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 21, 2006

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 21, 2008

Completed
Last Updated

July 2, 2017

Status Verified

April 21, 2008

First QC Date

June 19, 2006

Last Update Submit

June 30, 2017

Conditions

Early Pregnancy

Keywords

Menstrual CyclesEarly PregnancyReproductive HormonesStressAdrenal Function

Eligibility Criteria

Age16 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

University of Michigan

Ann Arbor, Michigan, 48109-0624, United States

Location

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

Related Publications (1)

  • Neugebauer R, Kline J, Stein Z, Shrout P, Warburton D, Susser M. Association of stressful life events with chromosomally normal spontaneous abortion. Am J Epidemiol. 1996 Mar 15;143(6):588-96. doi: 10.1093/oxfordjournals.aje.a008789.

    PMID: 8610676BACKGROUND
0

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

June 19, 2006

First Posted

June 21, 2006

Study Start

April 13, 2006

Study Completion

April 21, 2008

Last Updated

July 2, 2017

Record last verified: 2008-04-21

Locations

US(2)