Factors Influencing Fertility or Pregnancy Health

NCT04595760 | Active Not Recruiting

• 2 other identifiers: 10000058000058-E
• Study Type: observational
• Target: 231
• Locations: 1 country
• Sites: 1

Brief 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

Early Pregnancy Loss; Conception; Menstrual Cycles; Pregnancy Outcomes

Keywords

Pregnancy; Fertility; Reproductive Health; Fecundability; Natural History

Outcome Measures

Primary Outcomes (1)

• Time-to-pregnancy

  Reproductive function includes a spectrum of relevant endpoints and outcomes. We will examine behavioral and environmental exposures and reproductive health including menstrual cycles, conception, pregnancy loss, and pregnancy outcomes

  Prospectively measured

Secondary Outcomes (1)

• Pregnancy loss, hormone levels, birth outcomes, pregnancy complications

  Prospectively measured

Study Arms (1)

EPS Study Participants

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

Eligibility Criteria

• Age: 21 Years - 42 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• healthy white women aged 21-42 who were planning to become
• pregnant
• women enrolled in the 1982-1986 North Carolina Early Pregnancy
• Study (EPS) at the time they discontinued all methods of birth control

Sponsors & Collaborators

• National Institute of Environmental Health Sciences (NIEHS): lead

Study Sites (1)

National Institute of Environmental Health Sciences (NIEHS)

Bethesda, Maryland, 20892, United States

Location

MeSH Terms

Conditions

Abortion, Spontaneous

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital 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: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2020
• First Posted: October 22, 2020
• Study Start: October 19, 2020
• Primary Completion (Estimated): December 31, 2030
• Study Completion (Estimated): December 31, 2030
• Last Updated: July 14, 2026

Record last verified: 2025-12-02

Locations

US (1)