Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT04595760 |
| Other study ID # |
10000058 |
| Secondary ID |
000058-E |
| Status |
Active, not recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
October 19, 2020 |
| Est. completion date |
December 31, 2030 |
Study information
| Verified date |
September 20, 2023 |
| Source |
National Institutes of Health Clinical Center (CC) |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial 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....
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.
