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Factors Influencing Fertility or Pregnancy Health

NCT04595760 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 231

Last updated 2026-05-22

No results posted yet for this study

Summary

Background:

The North Carolina Early Pregnancy Study (EPS) was held from 1982 to 1986. Women who were trying to get pregnant took part in the study. They collected urine samples. They kept diaries. They filled out surveys. They answered questions about their partners. They were asked about their drug use. Data about air pollution and other exposures were also collected. A follow-up study was held from 2010 to 2011. Researchers want to use the data and samples to study factors that affect reproductive success.

Objective:

To examine behavioral and environmental exposures and reproductive health, such as menstrual cycles, conception, pregnancy loss, and pregnancy outcomes.

Eligibility:

The 221 healthy women age 21-42 who were planning to get pregnant and took part in the 1982-86 North Carolina EPS at the time they stopped using all birth control. A 2010-11 follow-up included 173 of these women.

Design:

This study uses existing data. No new data will be collected in this study.

Stored urine samples may be used. Data from surveys and other sources will be used. All of the women who gave data and samples will be included.

Electronic data is held in secure databases. The data is kept on computers that are password protected. Hard-copy data are stored in locked file cabinets.

The study will take place at more than one site. Data will be shared with groups outside the NIH....

Conditions

  • Menstrual Cycles
  • Conception
  • Early Pregnancy Loss
  • Pregnancy Outcomes

Sponsors & Collaborators

  • National Institute of Environmental Health Sciences (NIEHS)

    lead NIH

Principal Investigators

  • Anne Marie Z Jukic, Ph.D. · National Institute of Environmental Health Sciences (NIEHS)

Eligibility

Min Age
21 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-10-19
Primary Completion
2030-12-31
Completion
2030-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04595760 on ClinicalTrials.gov