NCT01132924

Brief Summary

Background: \- The purpose of the 1982 1986 North Carolina Early Pregnancy Study was to determine how often pregnancy loss occurs before women know they are pregnant. Women planning to become pregnant were asked to collect daily urine specimens and fill out daily diaries of their intercourse and menstrual bleeding. Researchers are interested in re-contacting this cohort to gather new information and to examine how accurately women can recall events that occurred earlier in their lives. Objectives: \- To follow-up with and gather additional information from women who were involved in the Early Pregnancy Study. Eligibility: \- Women who participated in the 1982 1986 North Carolina Early Pregnancy Study. Design:

  • Participants will receive and complete a questionnaire that includes the following topics:
  • Their pregnancy history.
  • The infant s birth, including method of delivery and induction of labor.
  • Early life exposures such as their own birth weight and their parents ages at their birth.
  • Tap water use during their attempt to conceive
  • General description of their behaviors during their participation in the original study, these include: physical activity, caffeine, alcohol, and soy food consumption.
  • Participants will return the surveys to the researchers in the stamped envelope provided with the questionnaire....

Trial Health

87
On Track

Trial Health Score

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

Enrollment
173

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

May 5, 2010

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 28, 2010

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 2, 2011

Completed
5.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 24, 2017

Completed
Last Updated

September 29, 2023

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

May 27, 2010

Last Update Submit

September 27, 2023

Conditions

Keywords

Early PregnancyGestational AgeFecundabilityOvulationRecallNatural History

Outcome Measures

Primary Outcomes (1)

  • Gestation Length

    Recall of time to pregnancy.

    Retrospective recall

Study Arms (1)

EPS Study Participants

Women who participated in the 1982-1986 North Carolina Early Pregnancy Study (EPS)

Eligibility Criteria

Age45 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who participated in the 1982-1986 North Carolina Early Pregnancy Study (EPS)

You may not qualify if:

  • This study is a follow-up study of women who participated in the NIEHS EPS. All of the women who participated in that study are eligible for this follow-up.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NIEHS, Research Triangle Park

Research Triangle Park, North Carolina, 27709, United States

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Study Officials

  • Anne Marie Z Jukic, Ph.D.

    National Institute of Environmental Health Sciences (NIEHS)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
NIH
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 27, 2010

First Posted

May 28, 2010

Study Start

May 5, 2010

Primary Completion

September 2, 2011

Study Completion

February 24, 2017

Last Updated

September 29, 2023

Record last verified: 2023-09

Locations