Factors Influencing Fertility or Pregnancy Health

• ClinicalTrials.gov Identifier: NCT04595760
• Recruitment Status: Active, not recruiting
• First Posted: October 22, 2020
• Last Update Posted: December 16, 2021
• Sponsor: National Institute of Environmental Health Sciences (NIEHS)
• Information provided by (Responsible Party): National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) )

Study Description

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.

Condition or disease
Menstrual Cycles; Conception; Early Pregnancy Loss; Pregnancy Outcomes

Detailed Description:

Existing self-reported data and assay results from the 1982-1986 North Carolina Early Pregnancy Study (EPS) and a subsequent 2010-2011 cohort follow-up study will be used to examine predictors of fertility and pregnancy outcomes. Some of these data will be harmonized with data from other studies by our collaborator (Harville PI, Tulane University) to examine factors, such as marijuana use in women and their partners, influencing reproductive success, including (but not limited to) conception, pregnancy loss, and birth outcomes. Women enrolled in the original EPS study after discontinuing birth control and were followed for the occurrence of a pregnancy. Participants completed daily diaries and collected first morning urine specimens which allowed the identification of hormonal endpoints. Thus, each woman s time to pregnancy was prospectively measured. In the EPS Follow-up study, women completed a questionnaire that included their recall of their time to pregnancy during the study. This allowed analysis of two major questions, one regarding the recall of time- to-pregnancy, and the other regarding the natural length of gestation. Several exposure metrics based on address geolocation data were calculated, including the distance from residence to nearest major road, air pollution and related exposures, light at night, and other exposures. Existing urine specimens can be assayed for numerous environmental contaminants including metals, pesticides, and drug metabolites (both over-the-counter medications like acetaminophen and drugs of abuse like marijuana or opioids). Urine specimens can also be used to examine nutritional markers such as phytoestrogen exposure and caffeine metabolites. Additional hormone measures may also be possible as metabolomics and technology improve. Thus, the stored EPS specimens can be leveraged to answer multiple, relevant fertility research questions. Women in the original tudy answered questions regarding their tobacco smoking and marijuana smoking. In addition, partners of the women were asked the same series of questions regarding tobacco and marijuana use.

We intend to use all of this existing data, assay results, and to perform additional urine assays, to examine factors influencing reproductive success, including (but not limited to) conception, pregnancy loss, and birth outcomes. To address some of these questions, de-identified data from the Early Pregnancy Study will be harmonized with data from other studies in the Preconception Period Analysis of Risks and Exposures Influencing Health and Development (PrePARED) consortium. Further, de-identified data and specimens will be shared with Dr. Ashley Boggs and colleagues to address the objectives below. Data and specimens will be shared with other qualified investigators in the future to address relevant research questions.

Study Design

• Study Type: Observational
• Actual Enrollment: 231 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Factors Influencing Fertility or Pregnancy Health
• Actual Study Start Date: October 19, 2020
• Estimated Primary Completion Date: December 31, 2030
• Estimated Study Completion Date: December 31, 2030

Groups and Cohorts

Group/Cohort
EPS Study Participants; Women who participated in the 1982-1986 North Carolina Early Pregnancy Study (EPS)

Outcome Measures

Primary Outcome Measures :

1. Time-to-pregnancy [ Time Frame: Prospectively measured ]
   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

Secondary Outcome Measures :

1. Pregnancy loss, hormone levels, birth outcomes, pregnancy complications [ Time Frame: Prospectively measured ]
   Reproductive function includes a spectrum ofnrelevant endpoints and outcomes. We will examine behavioral and environmental exposures and reproductive health including menstrual cycles, conception, pregnancy loss, and pregnancy outcomes.

Eligibility Criteria

• Ages Eligible for Study: 21 Years to 42 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

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

Criteria

• INCLUSION CRITERIA:
• 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

Contacts and Locations

Locations

United States, Maryland

National Institute of Environmental Health Sciences (NIEHS)

Bethesda, Maryland, United States, 20892

Sponsors and Collaborators

National Institute of Environmental Health Sciences (NIEHS)

Investigators

• Principal Investigator: Anne Marie Z Jukic, Ph.D.; National Institute of Environmental Health Sciences (NIEHS)

More Information

• Responsible Party: National Institute of Environmental Health Sciences (NIEHS)
• ClinicalTrials.gov Identifier: NCT04595760
• Other Study ID Numbers: 10000058; 000058-E
• First Posted: October 22, 2020
• Last Update Posted: December 16, 2021
• Last Verified: September 1, 2021

Keywords provided by National Institutes of Health Clinical Center (CC) ( National Institute of Environmental Health Sciences (NIEHS) ):

Pregnancy; Fertility; Reproductive Health; Fecundability; Natural History

Additional relevant MeSH terms:

Abortion, Spontaneous; Pregnancy Complications