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临床试验/NCT04595760
NCT04595760进行中(未招募)不适用

Factors Influencing Fertility or Pregnancy Health

National Institute of Environmental Health Sciences (NIEHS)1 个研究点 分布在 1 个国家目标入组 231 人开始时间: 2020年10月19日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
231
试验地点
1
主要终点
Time-to-pregnancy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
21 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

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

排除标准

  • 未提供

研究组 & 干预措施

EPS Study Participants

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

结局指标

主要结局

Time-to-pregnancy

时间窗: 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

次要结局

  • Pregnancy loss, hormone levels, birth outcomes, pregnancy complications(Prospectively measured)

研究者

发起方
National Institute of Environmental Health Sciences (NIEHS)
申办方类型
Nih
责任方
Sponsor

研究点 (1)

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